| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K974553 |
02/03/1998 |
3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) |
3M HEALTH CARE |
LINDA JOHNSEN |
| K973590 |
02/05/1998 |
HEMORRELIEF DEVICE |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
AHAVA STEIN |
| K982142 |
12/30/1998 |
MOUNTABLE ENDOSCOPIC KNIFE |
A.M. SURGICAL, INC. |
EUGENE T KING |
| K980366 |
02/27/1998 |
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 |
AARON MEDICAL INDUSTRIES |
ROB SARON |
| K983761 |
12/30/1998 |
AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 |
AARON MEDICAL INDUSTRIES |
J.ROBERT SARON |
| K983486 |
12/23/1998 |
SYSTEM U3 FOR NORFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K983571 |
12/30/1998 |
SYSTEM U3 FOR TETRACYCLINE |
AB BIODISK |
ANNE BOLMSTROM |
| K974779 |
02/13/1998 |
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER |
ABBOTT LABORATORIES |
ANDREW JOHNSON |
| K983424 |
12/01/1998 |
ABBOTT ARCHEITECT TOTAL B-HCG |
ABBOTT LABORATORIES |
KAREN L GATES |
| K983759 |
12/07/1998 |
ABBOTT ARCHITECT FERRITIN |
ABBOTT LABORATORIES |
LAURA GRANITZ |
| K974651 |
02/12/1998 |
ABBOTT AXSYM SYSTEM |
ABBOTT LABORATORIES |
PATTY O'BRIEN |
| K980013 |
02/04/1998 |
AMYLASE |
AC BIOCHEMICALS, INC. |
CHARLES C ALLAIN |
| K980012 |
02/25/1998 |
CREATINE KINASE REAGENT |
AC BIOCHEMICALS, INC. |
CHARLES C ALLAIN |
| K983306 |
12/18/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K983310 |
12/17/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K983309 |
12/14/1998 |
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K974474 |
02/24/1998 |
PEGASYS INTOUCH |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K983215 |
12/04/1998 |
MULTIPULSE CO2 LASER |
AESCULAP-MEDITEC GMBH |
WILLIAM T KELLEY |
| K974467 |
02/19/1998 |
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 |
AESCULAP-MEDITEC NORTH AMERICA |
WILLIAM T KELLEY |
| K983365 |
12/18/1998 |
AESCULAP MINOP SYSTEM |
AESCULAP, INC. |
MARY E HOLDEN |
| K983758 |
12/18/1998 |
YASARGIL TITANIUM ANEURYSM CLIPS |
AESCULAP, INC. |
VICTORIA MACKINNON |
| K974619 |
02/25/1998 |
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM |
AFP IMAGING CORP. |
MARY MCNAMARA-CULLINANE |
| K974775 |
02/19/1998 |
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE |
AIRTRONIC SERVICES, INC. |
ROBERT E WALTER |
| K974239 |
02/10/1998 |
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
| K974332 |
12/29/1998 |
VARIABLE PRESSURE SYRINGE PUMP |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K981054 |
12/07/1998 |
BROWNE GA INDICATOR FOR CIDEX PRODUCTS |
ALBERT BROWNE LTD. |
CYNTHIA J M NOLTE, PH.D |
| K983780 |
12/18/1998 |
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 |
ALCON LABORATORIES |
MICHAEL PFLEGER |
| K983973 |
12/18/1998 |
OPTI-ONE MULTI-PURPOSE SOLUTION |
ALCON LABORATORIES |
MICHAEL PFLEGER |
| K974505 |
02/17/1998 |
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 |
ALFA BIOTECH (UK) LTD. |
M JOHN TAYLOR |
| K974027 |
02/02/1998 |
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK |
ALFA BIOTECH (UK) LTD. |
M. JOHN TAYLOR |
| K973000 |
02/26/1998 |
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM |
ALIMENTERICS, INC. |
JANET G MURNICK |
| K984383 |
12/18/1998 |
ULTRACARE NEUTRALIZING TABLETS |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K983146 |
12/07/1998 |
ARSOFT |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K983770 |
12/31/1998 |
'RAPID DRUG SCREEN' 9-PANEL |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K974701 |
02/17/1998 |
ORGENTEC ANTI-MPO (P-ANCA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K974702 |
02/17/1998 |
ORGENTEC ANTI-PR3 (C-ANCA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K974561 |
02/19/1998 |
MOISTAIR FLUID AIR TUBING SET |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K974508 |
02/02/1998 |
DBEST ONE-STEP OVULATION TEST |
AMERITEK, INC. |
KUO CHIANG YEE |
| K982076 |
12/10/1998 |
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
AMIRA MEDICAL, INC. |
DAVID A HASKER |
| K974235 |
02/10/1998 |
AMPLAID AM50 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K972959 |
02/06/1998 |
AMPLAID MK22 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K974455 |
02/20/1998 |
ANATOM 1000 (A MINUS, A-) |
ANALOGIC CORP. |
ROBERT H FRENCH |
| K983599 |
12/11/1998 |
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT |
ANDWIN SCIENTIFIC |
NATALIE SARRAF |
| K983489 |
12/14/1998 |
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K974783 |
02/09/1998 |
ENCORE MARK IV POWDER FREE SURGICAL GLOVES |
ANSELL PERRY |
JAMES R CHATTERTON |
| K973465 |
02/19/1998 |
LATIS GRAFT CLEANING CATHETER |
APPLIED MEDICAL RESOURCES |
MARY JO STEGWELL |
| K972478 |
02/09/1998 |
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
| K983543 |
12/16/1998 |
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM |
ARGUS PHOTONICS GROUP |
KEVIN DICKENSON |
| K983649 |
12/11/1998 |
MAX-ACT |
ARRAY MEDICAL, INC. |
MICHAEL F CORSELLO |
| K970229 |
02/13/1998 |
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K974487 |
02/18/1998 |
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 |
ASI MEDICAL, INC. |
JOHN W MCPEEK |
| K974496 |
02/06/1998 |
A-2000 EEG MONITOR WITH BIS |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE MORGIDA |
| K983623 |
12/18/1998 |
MODULAP |
ATC TECHNOLOGIES, INC. |
MARIAN HARDING COCHRAN |
| K973829 |
02/23/1998 |
IRRIGATION BOTTLE |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K982268 |
12/04/1998 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K973760 |
02/18/1998 |
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE |
AVECOR CARDIOVASCULAR, INC. |
DENNIS E STEGER |
| K972554 |
02/17/1998 |
REGANES RADIONUCLIDE SEED MAGAZINE |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K974784 |
02/24/1998 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K984299 |
12/11/1998 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K983741 |
12/18/1998 |
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 |
AXELGAARD MFG. CO., LTD. |
DAN P JEFFREY |
| K970736 |
12/16/1998 |
BRAUN PREFILLED SYRINGE |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K974347 |
02/10/1998 |
BALDUR NON-STERILE COTTON SPONGES |
BALDUR SYSTEMS CORP. |
DAVID HU, PH.D. |
| K974845 |
12/08/1998 |
BTA STAT TEST PRESCRIPTION HOME USE |
BARD DIAGNOSTIC SCIENCES,INC. |
Glen Paul Freiberg |
| K983526 |
12/11/1998 |
VERTICAL LIFT |
BARNES,RICHARDSON & COLBURN |
ALYSA CHUMMANVECH |
| K983317 |
12/02/1998 |
BARRON MICROKERATOME SYSTEM, MODEL B2000 |
BARRON PRECISION INSTRUMENTS, L.L.C. |
MARK BARRON |
| K974397 |
02/10/1998 |
STERILE SALINE FOR CATHETER CARE |
BAXTER HEALTHCARE CORP. |
MARCIA MARCONI |
| K983345 |
12/07/1998 |
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY |
BAYER CORP. |
GABRIEL J MURACA JR |
| K983340 |
12/14/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K983747 |
12/30/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K984014 |
12/23/1998 |
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K983640 |
12/21/1998 |
SYNCHRON SYSTEMS LIPID CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K974816 |
02/20/1998 |
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 |
BECKMAN INSTRUMENTS, INC. |
ELLEN VOSS |
| K974564 |
02/17/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K981816 |
12/04/1998 |
CUE AMBULATORY VOLUMETRIC INFUSION PUMP |
BECTON DICKINSON CURLIN, LLC. |
CHARLES J WELLE |
| K973483 |
02/17/1998 |
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
| K974764 |
02/26/1998 |
INTROSYTE CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
C J WELLE |
| K974578 |
02/23/1998 |
GREPAFLOXACIN, 5 MG, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
| K972075 |
02/24/1998 |
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE |
BECTON DICKINSON VACUTAINER SYSTEMS |
JOHN SCHALAGO |
| K980098 |
02/05/1998 |
VACUTAINER BRAND PRONTO NEEDLES HOLDER |
BECTON DICKINSON VACUTAINER SYSTEMS |
JOHN SCHALAGO |
| K983773 |
12/22/1998 |
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MARTIN DALSING |
| K980418 |
02/27/1998 |
BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MICHAEL A CLARK |
| K974433 |
02/20/1998 |
CHROMOPHARE D 500, CHROMOPHARE D 530 |
BERCHTOLD HOLDING GMBH |
WOLFRAM K HILL |
| K983183 |
12/10/1998 |
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P |
BIEN AIR USA, INC. |
ARTHUR MATEEN |
| K972244 |
02/27/1998 |
NT2000 |
BIO-MEDICAL RESEARCH, LTD. |
GREG SHIPP |
| K981665 |
12/07/1998 |
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE |
BIO-MEDICAL SCIENCES, INC. |
MARK E DILLON |
| K984325 |
12/17/1998 |
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984319 |
12/22/1998 |
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984318 |
12/15/1998 |
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984323 |
12/15/1998 |
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984324 |
12/15/1998 |
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984327 |
12/22/1998 |
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 |
BIO-RAD |
ELIZABETH PLATT |
| K973350 |
02/09/1998 |
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST |
BIO-RAD |
TREVOR WALL |
| K984397 |
12/18/1998 |
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 |
BIO-RAD |
ELIZABETH PLATT |
| K984473 |
12/22/1998 |
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 |
BIO-RAD |
ELIZABETH PLATT |
| K984398 |
12/18/1998 |
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 |
BIO-RAD |
ELIZABETH PLATT |
| K984399 |
12/18/1998 |
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 |
BIO-RAD |
ELIZABETH PLATT |
| K984400 |
12/18/1998 |
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 |
BIO-RAD |
ELIZABETH PLATT |
| K984396 |
12/18/1998 |
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 |
BIO-RAD |
ELIZABETH PLATT |
| K984464 |
12/22/1998 |
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 |
BIO-RAD |
ELIZABETH PLATT |
| K984476 |
12/22/1998 |
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 |
BIO-RAD |
ELIZABETH PLATT |
| K984475 |
12/22/1998 |
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 |
BIO-RAD |
ELIZABETH PLATT |
| K984479 |
12/22/1998 |
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 |
BIO-RAD |
ELIZABETH PLATT |
| K984470 |
12/22/1998 |
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 |
BIO-RAD |
ELIZABETH PLATT |
| K984478 |
12/22/1998 |
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 |
BIO-RAD |
ELIZABETH PLATT |
| K980556 |
02/25/1998 |
LIQUICHEK CARDIAC MARKERS CONTROL LT |
BIO-RAD |
ELIZABETH PLATT |
| K984462 |
12/22/1998 |
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 |
BIO-RAD |
ELIZABETH PLATT |
| K984071 |
12/03/1998 |
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 |
BIO-RAD |
ELIZABETH PLATT |
| K984225 |
12/14/1998 |
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 |
BIO-RAD |
ELIZABETH PLATT |
| K983807 |
12/16/1998 |
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 |
BIO-RAD |
ELIZABETH PLATT |
| K984268 |
12/17/1998 |
VARIANT II HEMOGLOBIN A1C PROGRAM |
BIO-RAD |
JULIET CARRARA |
| K980117 |
12/18/1998 |
NUVO BARRIER FILM |
BIOMEDICAL DEVELOPMENT CO. |
RICHARD A HAMER |
| K983710 |
12/02/1998 |
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH |
BIOMET, INC. |
FRED MCCLURE |
| K983641 |
12/04/1998 |
HOLLAND FEMORAL NAIL SYSTEM |
BIOMET, INC. |
FRED MCCLURE |
| K983452 |
12/03/1998 |
NELSON RESURFACING HEAD |
BIOMET, INC. |
JULIE K RYAN |
| K983967 |
12/16/1998 |
PEDIATRIC CANNULATED OSTEOTOMY PLATES |
BIOMET, INC. |
LONNIE WITHAM |
| K980178 |
02/12/1998 |
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY |
BIONOSTICS, INC. |
BRUCE R WILLIAMS |
| K981824 |
12/22/1998 |
OPTICOAT T3 EIA KIT |
BIOTECX LABORATORIES, INC. |
MOHAN MEHRA |
| K984112 |
12/22/1998 |
ADVENT |
BISCO, INC. |
STEVEN J DURAY |
| K974483 |
02/09/1998 |
NTL-FLOW |
BISCO, INC. |
JAMES L SANDRIK |
| K984372 |
12/14/1998 |
ELECSYS CALCHECK TROPONIN T |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K984105 |
12/08/1998 |
ELECSYS TROPONIN T STAT TEST |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K983503 |
12/01/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 |
BOEHRINGER MANNHEIM CORP. |
JENNIFER L TRIBBETT |
| K974809 |
02/05/1998 |
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K974810 |
02/05/1998 |
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K974811 |
02/10/1998 |
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K974247 |
02/10/1998 |
40 CC GRANDE |
BOSTON SCIENTIFIC CORP. |
LEO BASTA |
| K974541 |
02/09/1998 |
MODIFIED URETERAL INDWELLING CATHETER/STENT |
BOSTON SCIENTIFIC CORP. |
TERRY MYERS |
| K972512 |
02/12/1998 |
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL |
BOSTON SCIENTIFIC SCIMED, INC. |
RON BENNETT |
| K984431 |
12/30/1998 |
ULTIMA AIRFLOW PRESSURE SENSOR |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K983454 |
12/16/1998 |
PAIN CARE 2000 |
BREG, INC. |
KATHLEEN BARBER |
| K974379 |
02/18/1998 |
ULTRANEB |
BREMED ITALIA, S.R.L. |
MARK HEBENSTREIT |
| K974295 |
02/10/1998 |
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING |
BYRON MEDICAL |
TODD LANE |
| K973962 |
02/19/1998 |
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS |
C.R. BARD, INC. |
SANDRA PERREAND |
| K983498 |
12/15/1998 |
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
| K971336 |
12/01/1998 |
CAIRD TECHNOLOGY SPIROMETER |
CAIRD TECHNOLOGY |
JAMES H BROWN |
| K971169 |
02/17/1998 |
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) |
CAMBRIDGE BIOTECH CORP. |
REBECCA LEAPER |
| K971170 |
02/17/1998 |
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) |
CAMBRIDGE BIOTECH CORP. |
REBECCA LEAPER |
| K974381 |
02/10/1998 |
CANDELA GENTLELASE GL DERMATOLOGICAL LASER |
CANDELA CORP. |
JAN CAPLAN |
| K983026 |
12/02/1998 |
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K983653 |
12/22/1998 |
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D |
CARDIAC PATHWAYS CORP. |
ERIN DIGNAN |
| K983789 |
12/17/1998 |
CARESIDE CALCIUM, ORIGINAL |
CARESIDE, INC. |
KENNETH B ASARCH PHARM |
| K983182 |
12/10/1998 |
ALOE THERAPY ORAL RINSE |
CARRINGTON LABORATORIES, INC. |
E.J. Smith |
| K972904 |
02/20/1998 |
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL |
CASCO STANDARDS |
CHRISTINE V BEACH |
| K974357 |
02/02/1998 |
UTERINE MANIPULATOR/INJECTOR |
CATHETER RESEARCH, INC. |
JOHN A STEEN, PH.D. |
| K984042 |
12/04/1998 |
QUADRANT CORE LC |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984044 |
12/16/1998 |
QUADRANT POSTERIOR DENSE |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984043 |
12/04/1998 |
QUADRANT TOTAL ETCH |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984041 |
12/04/1998 |
QUADRANT UNIVERSAL LC |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K981746 |
12/07/1998 |
CELL ROBOTICS' LASETTE |
CELL ROBOTICS, INC. |
CONNIE WHITE |
| K973285 |
02/25/1998 |
D/SENSE-T |
CENTRIX, INC. |
JOHN DISCKO |
| K981972 |
12/07/1998 |
GREEN-OR DENTIN DESENSITIZER |
CENTRIX, INC. |
JOHN DISCKO |
| K983685 |
12/04/1998 |
BONE BAND |
CHAPEL AND ASSOC. |
JAMES F CHAPEL |
| K974029 |
02/12/1998 |
ACS TOBRAMYCIN |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K983432 |
12/17/1998 |
SUPREME II CONTROL SOLUTIONS |
CHRONIMED, INC. |
JEFFREY P HEATON |
| K974579 |
02/18/1998 |
PERCSCOPE MODEL 2600 |
CLARUS MEDICAL SYSTEMS, INC. |
DALE SAPPENFIELD |
| K974389 |
02/19/1998 |
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER |
CLINICAL INNOVATIONS, INC. |
WM. DEAN WALLACE |
| K983463 |
12/11/1998 |
SURECAUT DIAMOND LASER KNIFE |
CLINICON CORP. |
GERALD S PALECKI |
| K974301 |
02/06/1998 |
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER |
CLK INTL., INC. |
GEORGE Q KUO |
| K983921 |
12/28/1998 |
AUTOSTAT II ENA SCREEN ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K983714 |
12/23/1998 |
SOLARTEC SOURCE 270, MODEL # 90123 |
COGENT LIGHT TECHNOLOGIES, INC. |
DON KNAEPPLE |
| K983173 |
12/16/1998 |
BIATAIN FOAM ADHESIVE DRESSING |
COLOPLAST CORP. |
M. SYDNEY LILLY |
| K983163 |
12/16/1998 |
BIATAIN FOAM DRESSING |
COLOPLAST CORP. |
M. SYDNEY LILLY |
| K983519 |
12/30/1998 |
COMFEEL SEASORB DRESSING |
COLOPLAST CORP. |
M.SYDNEY LILLY |
| K983553 |
12/07/1998 |
ANTI-TG IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983605 |
12/16/1998 |
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983606 |
12/16/1998 |
IS BORRELIA BURGDORFERI IGM TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K972676 |
02/23/1998 |
URINE SCREENING DEVICE |
COMBACT DIAGNOSTIC SYSTEMS LTD. |
THOMAS M TSAKERIS |
| K980378 |
12/09/1998 |
MELODIE INFUSION PUMP |
COMPAGNIE DE DEVELOPPEMENT AGUETTANT |
DIANE MCCOLL |
| K973700 |
02/24/1998 |
HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
Douglas Bueschel |
| K983568 |
12/21/1998 |
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER |
CONTRACT LATEX DIPPERS SDN BHD |
VINAYAGAN RAMALINGAM |
| K974205 |
02/06/1998 |
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K974823 |
02/20/1998 |
NONWOVEN DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K983415 |
12/01/1998 |
DELIVERY SHEATH |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K983116 |
12/03/1998 |
ELECTROSURGICAL INFLATABLE BASKET ELECTRODES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K983609 |
12/16/1998 |
COOK TEST TUBE HEATER |
COOK OB/GYN |
BRENDA DAVIS |
| K983594 |
12/21/1998 |
EMBRYO TRANSFER CATHETERS/SETS |
COOK OB/GYN |
DEBBIE SCHMITT |
| K983590 |
12/21/1998 |
GIFT CATHETER SET/S |
COOK OB/GYN |
BRENDA DAVIS |
| K983587 |
12/16/1998 |
HYSTEROSCOPIC GIFT CATHETER SETS |
COOK OB/GYN |
BRENDA DAVIS |
| K983591 |
12/21/1998 |
INTRATUBAL TRANSFER SETS |
COOK OB/GYN |
DEBBIE SCHMITT |
| K972630 |
02/02/1998 |
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM |
COOPERSURGICAL, INC. |
SHEILA HEMEON-HEYER |
| K974448 |
02/06/1998 |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ARIEL MACTAVISH |
| K984500 |
12/23/1998 |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ARIEL MACTAVISH |
| K980823 |
12/18/1998 |
CORDIS NITINOL STENT AND DELIVERY SYSTEM |
CORDIS CORP. |
JOAN MARTIN |
| K974222 |
02/10/1998 |
CES MASSTRANSIT INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
Lisa Wells |
| K982434 |
12/22/1998 |
REAADS IGA ANTI-B2GP 1 TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K982391 |
12/07/1998 |
REAADS IGG ANTI-B2GPI TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K982433 |
12/07/1998 |
REAADS IGM ANTI-B2GP1 TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K983914 |
12/22/1998 |
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K973425 |
02/27/1998 |
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM |
CORIN U.S.A. |
CRAIG CORRANCE |
| K982651 |
12/11/1998 |
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER |
COROMETRICS MEDICAL SYSTEMS, INC. |
RICHARD CEHOVSKY |
| K974494 |
02/10/1998 |
RENAMEL FLOWABLE COMPOSITE |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K974320 |
02/03/1998 |
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM |
CRYOGEN, INC. |
CHERYL L SHEA |
| K974256 |
02/25/1998 |
ECAT PET SCANNERS |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K983277 |
12/16/1998 |
LIGHTSOURCE OR ILLUMINATOR MODEL I-100 |
CUDA PRODUCTS CO. |
KIM REED |
| K974900 |
02/27/1998 |
CYNOSURE PHOTOGENICA 532 LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K972883 |
02/26/1998 |
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K984193 |
12/14/1998 |
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984191 |
12/10/1998 |
MYOGLOBIN FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984093 |
12/14/1998 |
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984065 |
12/14/1998 |
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983392 |
12/15/1998 |
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR |
DATA RAY |
GREG ROBERTS |
| K982091 |
12/22/1998 |
CS/3 COMPACT AIRWAY MODULE, M-COVX |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
| K974101 |
02/06/1998 |
DATEX-ENGSTROM NETWORK |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K983366 |
12/23/1998 |
TRIP TONOMETRY CATHETER, 16F |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K973409 |
02/27/1998 |
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K981680 |
12/31/1998 |
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS |
DAYTON WATER SYSTEMS |
CINDY HELTON |
| K973221 |
02/09/1998 |
COMPOSITE 168 RESTORATIVE SYSTEM |
DENTSPLY INTL. |
JEFFERY LEHN |
| K973235 |
02/05/1998 |
DYRACT AP RESTORATIVE |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K980332 |
02/24/1998 |
MTA MATERIAL |
DENTSPLY INTL. |
P JEFFREY LEHN |
| K984458 |
12/31/1998 |
DEPUY ACE SPIDER PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K983853 |
12/22/1998 |
DEPUY ACE TIMAX META PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K983491 |
12/02/1998 |
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983906 |
12/18/1998 |
DEPUY ORTHOTECH SPIKED WASHER |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983583 |
12/03/1998 |
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS |
DEPUY, INC. |
LYNETTE WHITAKER |
| K984378 |
12/30/1998 |
DEPUY ACROMED MOSS SPINAL SYSTEM |
DEPUY, INC. |
LYNNETTE WHITAKER |
| K974573 |
02/18/1998 |
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
DEPUY, INC. |
CHERYL K HASTINGS |
| K980509 |
02/26/1998 |
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS |
DEROYAL INDUSTRIES, INC. |
CAMILLE MATLOCK |
| K972788 |
12/22/1998 |
CROSSLAPS ELISA |
DEVICES AND DIAGNOSTICS CONSULTING GROUP |
TOM TSAKARIS |
| K980316 |
02/12/1998 |
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974874 |
02/12/1998 |
BILIRUBIN-SL (TOTAL) ASSAY |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
KAREN CALLBECK |
| K983954 |
12/17/1998 |
ALASTAT MICROPLATE MIXED ALLERGEN PANELS |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983263 |
12/07/1998 |
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K982078 |
12/11/1998 |
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983972 |
12/07/1998 |
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983880 |
12/18/1998 |
TRANSFERRIN SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K982650 |
12/16/1998 |
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) |
DIDECO S.P.A. |
ROSINA ROBINSON |
| K980120 |
02/06/1998 |
DIGENE DML 2000 MICROPLATE LUMINOMETER |
DIGENE CORP. |
CONSTANCE A FINCH |
| K981881 |
12/02/1998 |
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K973949 |
02/06/1998 |
PERIOPERATIVE DATA MANAGEMENT SYSTEM |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K983219 |
12/07/1998 |
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 |
DRAGER, INC. |
HARALD KNEUER |
| K973326 |
02/24/1998 |
QUIKPAC II ONE STEP BENZODIAZEPINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K973269 |
02/25/1998 |
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K984023 |
12/08/1998 |
MAXVIEW DIAGNOSTIC WORKSTATION |
DYNAMIC HEALTHCARE TECHNOLOGIES, INC. |
KAREN W WHITE |
| K983348 |
12/11/1998 |
DYNAREX TRACHEOSTOMY SPONGE |
DYNAREX CORP. |
JOHN G MOULDEN |
| K974504 |
02/27/1998 |
EPS |
E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC |
STU BUSH |
| K971619 |
02/27/1998 |
MICROFUSE MEMBRANE INFUSION CATHETER |
E-MED CORP. |
JOHN DOCKTER |
| K974132 |
02/25/1998 |
VOICE MASTER PROSTHESIS |
E. BENSON HOOD LAB, INC. |
ANTHONY M SACCHETTI |
| K971471 |
02/09/1998 |
ELASTYREN POWDER-FREE SURGICAL GLOVE |
ECI MEDICAL TECHNOLOGIES, INC. |
MICHAEL FORER |
| K974259 |
12/01/1998 |
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
R D HIBBERT |
| K971799 |
02/06/1998 |
PRECISION FLOW OSV II |
ELEKTA IMPLANTS, SA |
BARBARA RAMSEYER |
| K983313 |
12/11/1998 |
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY |
ELSCINT, INC. |
STEVEN M KAY |
| K983473 |
12/17/1998 |
FERTILMARQ TEST KIT |
EMBRYOTECH LABORATORIES, INC. |
ANN D MCGONIGLE |
| K982832 |
12/23/1998 |
PROGUARD, RR-1, RR-2 |
EMERSON & CO. S.R.L. |
STEFANO COSTIGLTOLO |
| K983484 |
12/28/1998 |
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE |
EMPI |
CAROLYN M STEELE HUSTEN |
| K974617 |
12/01/1998 |
PERIPHERAL VASCULAR DILATOR |
ENDOVASCULAR INSTRUMENTS, INC. |
JACK SPEER |
| K973395 |
02/13/1998 |
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE |
EPITOPE, INC. |
CAROLINE SAYRE |
| K983414 |
12/16/1998 |
EVERBOND |
ESPE DENTAL AG |
A. PETERMANN |
| K974458 |
02/02/1998 |
COMPOLUTE APLICAP |
ESPE DENTAL-MEDIZIN GMBH & CO.KG. |
BARBARA WAGNER-SCHUH |
| K983536 |
12/18/1998 |
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS |
ETHICON ENDO-SURGERY, INC. |
EDWIN O BILLIPS |
| K974299 |
02/13/1998 |
PANACRYL |
ETHICON, INC. |
GREGORY JONES |
| K980041 |
02/04/1998 |
CARESIDE ALBUMIN |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K980057 |
02/05/1998 |
CARESIDE BUN |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K980042 |
02/04/1998 |
CARESIDE TOTAL PROTEIN |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K983199 |
12/14/1998 |
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL |
FIBRA SONICS, INC. |
ROBERT BROHM |
| K974219 |
02/20/1998 |
FACEPLATE ASSEMBLY |
FINETONE HEARING INSTRUMENTS |
PAUL MENEZES |
| K974839 |
02/04/1998 |
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT |
FIRST MEDICAL, INC. |
VAN N JOHNSON |
| K974358 |
02/10/1998 |
FRIALIT -2 SCREW |
FRIATEC AG |
ROBERT SLOMOFF |
| K974359 |
02/10/1998 |
FRIALIT-2 CYLINDER |
FRIATEC AG |
ROBERT J SLOMOFF |
| K983561 |
12/16/1998 |
FUJINON EVL-F VIDEO LAPROSCOPE |
FUJINON, INC. |
GARY A ADLER |
| K980248 |
02/18/1998 |
ACRI R NEEDLE |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K974355 |
02/17/1998 |
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K983256 |
12/15/1998 |
ADVANTAGE WINDOWS (AW) FUSION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K974367 |
02/13/1998 |
ADVANTX LCN, ADVANTX LCLP |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K972990 |
02/05/1998 |
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGERR |
| K982712 |
12/18/1998 |
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
STEPHEN M PAGE |
| K983847 |
12/01/1998 |
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT |
GERMIPHENE CORP. |
LESLIE DRAKE |
| K973225 |
02/10/1998 |
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) |
GETINGE/CASTLE, INC. |
MICHAEL J PALLADINO |
| K980053 |
02/24/1998 |
GLENROE CHAIN |
GLENROE TECHNOLOGIES |
JOHN BOZMAN |
| K984218 |
12/17/1998 |
OASIS |
GLIMEX CORP. |
JEFF HACKETT |
| K973663 |
02/10/1998 |
PALJET-B |
GOLDEN GATE BIO-DEVICE |
MARK J HASTINGS |
| K974626 |
02/06/1998 |
P.T. MACHINE |
GOODMAN, GOODMAN & GOODMAN |
MARC H BOZEMAN |
| K974237 |
02/10/1998 |
GSI 70 AUDIOPATH SCREENER |
GRASON-STADLER, INC. |
NORMAN L SCHULTZ |
| K971348 |
02/27/1998 |
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM |
GREEN FIELD MEDICAL SOURCING, INC. |
DONALD R GORSUCH |
| K983952 |
12/28/1998 |
GREINER VACUETTE BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K974873 |
02/05/1998 |
VACUETTE (MULTI-USE HOLDER) |
GREINER MEDITECH, INC. |
DOUGLAS L HARRIS |
| K983055 |
12/30/1998 |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 |
GUIDANT CORP. |
SUSAN SILAVIN |
| K973197 |
02/27/1998 |
FIRE STICK |
H.S. INTL. CO., INC. |
HENRY SHAPIRO |
| K982337 |
12/29/1998 |
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER |
HAIDYLENA MEDICAL EGYPT |
SAMEH TAMIM |
| K983535 |
12/29/1998 |
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 |
HANS HERMANN GMBH |
DAGMAR S MASER |
| K983752 |
12/10/1998 |
ALUMINA-ZINC OXIDE POWDERS F AND R |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K974318 |
02/13/1998 |
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB |
HEALTHCARE SERVICE AND SUPPLY |
RICK ROEDER |
| K982426 |
12/17/1998 |
SPIFE ALKALINE HEMOGLOBIN |
HELENA LABORATORIES |
PAT FRANKS |
| K974390 |
02/04/1998 |
GLUMA ONE BOND |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K984286 |
12/17/1998 |
HEARTSTREAM ELECTRODE ADAPTER |
HEWLETT-PACKARD CO. |
WILLIAM D JORDAN |
| K974420 |
02/19/1998 |
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION |
HEWLETT-PACKARD CO. |
STEVEN A CLARKE |
| K981781 |
12/04/1998 |
ELECTROSURGICAL UNIT |
HILL-MED, INC. |
ERNESTO ACKERMAN |
| K972111 |
02/02/1998 |
RUMORS DYNAMIC AIR THERAPY UNIT |
HILL-ROM, INC. |
EDWIN BILLS |
| K972740 |
02/06/1998 |
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) |
HIMEX PRODUCTION CORP. |
GREG GEORGES |
| K974212 |
02/09/1998 |
AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES J ROGERS |
| K984278 |
12/11/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K984272 |
12/11/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K974498 |
02/26/1998 |
STRATIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K980209 |
02/20/1998 |
SIMPLICARE THIN FILM WOUND DRESSINGS |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K980171 |
02/27/1998 |
DERMASENSE PLUS DISPERSIVE ELECTRODE |
HORIZON MEDICAL, INC. |
PHILIP L RITGER |
| K980926 |
12/16/1998 |
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980626 |
12/11/1998 |
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980632 |
12/11/1998 |
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980925 |
12/16/1998 |
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K971206 |
02/11/1998 |
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING |
HOWMEDICA CORP. |
MARGARET CROWE |
| K983528 |
12/23/1998 |
MICRO DYNAMIC MESH |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K983404 |
12/22/1998 |
TYPE 3 FEMORAL COMPONENTS |
HOWMEDICA CORP. |
FRANK MAAS |
| K974289 |
02/12/1998 |
EPI-UNION PLATING SYSTEM |
HOWMEDICA, INC. |
VIVIAN KELLY |
| K974316 |
02/13/1998 |
HYDROFERA FEMORAL WICK |
HYDROFERA, LLC. |
HEATHER S BOND |
| K983559 |
12/24/1998 |
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
ICU MEDICAL, INC. |
SHERYL SAENZ |
| K974173 |
02/25/1998 |
ERECAID SYSTEM/STAY EREC SYSTEM |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
RONALD H BERGESON |
| K973336 |
02/05/1998 |
IMEX STETHODOP |
IMEX MEDICAL SYSTEMS, INC. |
DAVID W WAGNER |
| K983924 |
12/18/1998 |
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K972145 |
02/24/1998 |
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K974463 |
02/09/1998 |
IMMUNO CONCEPTS ANCA TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K974478 |
02/09/1998 |
IMMUNO CONCEPTS ANCA TEST SYSTEMS |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K980637 |
12/16/1998 |
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT |
IMPLEX CORP. |
ROBERT POGGIE, PH.D. |
| K983128 |
12/03/1998 |
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY |
IMPLEX CORP. |
JOHN SCHALAGO |
| K983769 |
12/15/1998 |
DISTAFLO BYPASS GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K974074 |
02/17/1998 |
INFUSION DYNAMICS POWER INFUSER |
INFUSION DYNAMICS, INC. |
THOMAS BECZE |
| K973381 |
02/18/1998 |
BIOROC EZ SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN M PAGE |
| K974049 |
02/18/1998 |
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN PAGE |
| K974520 |
02/06/1998 |
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM |
INNOVATIVE TECHNOLOGIES (US), INC. |
JULIE CHAFFEE |
| K982804 |
12/16/1998 |
SPYROGEL HYDROGEL WOUND AND BURN DRESSING |
INNOVATIVE TECHNOLOGIES (US), INC. |
JULIE CHAFFEE |
| K983303 |
12/09/1998 |
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS |
INNOVATIVE TECHNOLOGIES LTD. |
CHRISTOPHER OAKES |
| K974645 |
02/12/1998 |
FEMASSIST FLEXIBLE |
INSIGHT MEDICAL CORP. |
MICHAEL G VERGANO |
| K973066 |
02/03/1998 |
NON-REBREATHING 'T' (BE 117) |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
| K983073 |
12/16/1998 |
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET |
INTEGRA BIOTECHNICAL LLC. |
WILLIAM BERGELIN |
| K982562 |
12/28/1998 |
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER |
INTEGRATED ORBITAL IMPLANTS, INC. |
JEANNE DUNHAM |
| K974203 |
02/04/1998 |
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM |
INTEGRATED ORBITAL IMPLANTS, INC. |
FLOYD G LARSON |
| K972775 |
02/27/1998 |
FASTDAM |
INTERDENT, INC. |
WILLIAM GRONDIN |
| K973328 |
12/10/1998 |
INTERSOURCE |
INTERNATIONAL BRACHYTHERAPY, SA |
VINCENT E CONIGLIONE |
| K981253 |
12/11/1998 |
ULTRACON ULTRAFILTRATOR |
INTERPORE INTL. |
LYNN M RODARTI |
| K974833 |
02/13/1998 |
CK-NAC REAGENT |
INTERSECT SYSTEMS, INC. |
MARK E LEGAZ |
| K982311 |
12/14/1998 |
BARTELS CINAKIT CMV ANTIGENEMIA |
INTRACEL CORP. |
FEDORA DAYE CONTRERAS |
| K983777 |
12/18/1998 |
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM |
INVACARE CORP. |
EDWARD A KROLL |
| K982612 |
12/14/1998 |
ESP7 VENOUS IMAGE |
IRONMASTER, INC. |
FRED DAWSON |
| K971708 |
02/18/1998 |
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE |
J & J ENGINEERING, INC. |
ANAND AKERKAR |
| K974336 |
02/13/1998 |
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. |
J-LLOYD MEDICAL, INC. |
JAMES L SKAGGS |
| K974335 |
02/13/1998 |
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. |
J-LLOYD MEDICAL, INC. |
JAMES L SKAGGS SR. |
| K974376 |
02/18/1998 |
JTECH ADJUSTER REFLEX GUN |
J-TECH MEDICAL, INC. |
E.J SMITH |
| K974727 |
02/24/1998 |
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR |
J.B.C AND CO. |
PRISCILLA L MIER |
| K984164 |
12/29/1998 |
JELBOND NP |
JELENKO CO. |
TRIDIB DASGUPTA |
| K980283 |
02/25/1998 |
VITROS CHEMISTRY PRODUCTS CRBM SLIDES |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
CHARLES C MORGANSON |
| K983362 |
12/16/1998 |
NU-GEL * WOUND DRESSING |
JOHNSON & JOHNSON MEDICAL, INC. |
TERRY J DAGNON |
| K972498 |
02/17/1998 |
OBSERVER * CENTRAL STATION |
JOHNSON & JOHNSON MEDICAL, INC. |
DARLENE T KORAB |
| K982812 |
12/04/1998 |
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
MARY E GRAY |
| K982379 |
12/18/1998 |
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K974331 |
02/06/1998 |
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K974195 |
02/04/1998 |
FLEXIBLE TIP DIGITAL THERMOMETER |
K-JUMP HEALTH CO., LTD. |
ROBERT J ZAPPA |
| K983142 |
12/07/1998 |
KSEA C-MOUNT ARTHROSCOPES |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K983363 |
12/18/1998 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K973909 |
02/27/1998 |
KSEA ENDOTIP SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K980878 |
12/28/1998 |
PULMOTRACK,MODEL 1010 |
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. |
CHARLES S IRVING |
| K981737 |
12/09/1998 |
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 |
KATECHO, INC. |
LORNE S CHARNBERG |
| K974829 |
02/12/1998 |
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) |
KAWASUMI LABORATORIES CO., LTD. |
DONALD R STONE |
| K973827 |
02/11/1998 |
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION |
KIMBERLY-CLARK CORP. |
LARRY K LUDT |
| K973900 |
02/24/1998 |
TESTOTERONE ELISA |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K982995 |
12/04/1998 |
ACCUTRAX, MODEL EPF840 |
KORR MEDICAL TECHNOLOGIES, INC. |
SCOTT KOFOED |
| K983723 |
12/07/1998 |
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K983721 |
12/07/1998 |
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K984019 |
12/23/1998 |
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K984020 |
12/23/1998 |
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K983227 |
12/11/1998 |
POWER BLOCK |
KREATIV, INC. |
JOSEPH M FOREHAND |
| K980232 |
02/24/1998 |
CLEARFIL DC CEMENT |
KURARAY COMPANY, LTD. |
HIROYUKI YONEKURA |
| K974348 |
02/13/1998 |
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING |
LABORATOIRES URGO S.A. |
EVAN DICK |
| K974229 |
02/10/1998 |
LS-905 FIBERCHOICE ADAPTER SYSTEM |
LASER PERIPHERALS LLC. |
NANCY L ARNOLD |
| K983965 |
12/22/1998 |
CO2 LASER COUPLER |
LASER, INC. |
WILLIAM K PRZBYBLA |
| K984110 |
12/18/1998 |
LASERSCOPE COOLSPOT |
LASERSCOPE |
PAUL H HARDIMAN |
| K980131 |
02/17/1998 |
ALEX TA2 ERASER |
LIGHT AGE, INC. |
RICK FROST |
| K972975 |
12/22/1998 |
LIGHT DIAGNOSTICS RABIES DFA REAGENT |
LIGHT DIAGNOSTICS |
CINDY D PENNY |
| K973758 |
02/27/1998 |
BIOSCREW ABSORBABLE INTERFERENCE SREW |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K974616 |
02/05/1998 |
SINGER ACUPUNCTURE NEEDLES |
LORAC, INC. |
SANDRA SOBCZAK |
| K974437 |
02/13/1998 |
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE |
LUNAR CORP. |
KENNETH D BUROKER |
| K983724 |
12/08/1998 |
ORCA-DX BONE DENSITOMETER |
LUNAR CORP. |
KENNETH D BUROKER |
| K983564 |
12/08/1998 |
PRODIGY TOTAL BODY SOFTWARE |
LUNAR CORP. |
KENNETH D BUROKER |
| K974543 |
02/10/1998 |
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER |
LUTHER MEDICAL PRODUCTS, INC. |
BARBARA C LUTHER |
| K974233 |
02/03/1998 |
LYSONIX IRRIGATION SYSTEM |
LYSONIX, INC. |
RONALD F LAGERQUIST |
| K981942 |
12/14/1998 |
LATEX POWDER FREE EXAMINATION GLOVES |
MAIKA RUBBER PRODUCTS SDN BHD |
RAVI ANBIL |
| K980211 |
02/06/1998 |
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES |
MANAN MEDICAL PRODUCTS, INC. |
KARL SWARTZ |
| K984177 |
12/18/1998 |
MODIFICATION TO SKVEKPATCH |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K974199 |
02/06/1998 |
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION |
MARQUETTE MEDICAL SYSTEMS, INC. |
KRISTIN PABST |
| K980845 |
12/14/1998 |
MS-900S, MS-900SPM & MS-900SFM |
MARS MEDICAL PRODUCTS |
E J SMITH |
| K980150 |
02/09/1998 |
POWDER-FREE NITRILE EXAMINATION GLOVES |
MASJU SDN. BHD. |
HENG CHENG HUI |
| K974894 |
02/12/1998 |
KROMATICA COLOR CHANGING ALGINATE |
MATECH, INC. |
PAUL L SAXTON |
| K983448 |
12/18/1998 |
ML UNIVERSAL TUBING |
MED-LOGICS, INC. |
BETTY ROSS |
| K981992 |
12/15/1998 |
ELECTRON WEDGE MODEL MT-EW-1000 |
MED-TEC,INC. |
DONALD F RIIBE |
| K972207 |
02/23/1998 |
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM |
MEDCOMP |
JEANNE M CUSH |
| K974526 |
02/05/1998 |
EASYBLOOD GAS ANALYZER |
MEDICA CORP. |
Photios Makris |
| K984277 |
12/09/1998 |
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT D KINGHORN |
| K971925 |
02/23/1998 |
MEDCOMP BIO-FLEX CS CATHETER (CS100) |
MEDICAL COMPONENTS, INC. |
JEANNE CUSH |
| K983412 |
12/10/1998 |
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K980191 |
02/09/1998 |
MANAN BILIARY DRAINAGE CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K980452 |
02/18/1998 |
MANAN LIVER BIOPSY KIT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K980226 |
02/18/1998 |
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K980196 |
02/03/1998 |
MD TECH BIOPSY SET FOR BONE AND BONE MARROW |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K974542 |
02/17/1998 |
TRUE VISION, TRUE VISION II |
MEDICAL DYNAMICS, INC. |
EDWIN L ADAIR |
| K983601 |
12/15/1998 |
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K983459 |
12/08/1998 |
PULSED OXYGEN CONSERVING DEVICE, POCD |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K973120 |
02/25/1998 |
READYCATH CATHETER |
MEDICAL TECHNOLOGIES OF GEORGIA |
RICHARD STARKE |
| K974570 |
02/27/1998 |
PERITONEAL DIALYSIS CATHETER CONNECTOR |
MEDIGROUP, INC. |
JOHN NAVIS |
| K982303 |
12/08/1998 |
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST |
MEDISENSE, INC. |
MICHAEL HALPIN |
| K982694 |
12/14/1998 |
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K972119 |
02/02/1998 |
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) |
MEDOVATIONS, INC. |
CHARLES G STANFORD |
| K984211 |
12/23/1998 |
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 |
MEDSCAND AB |
TENNY P TSE |
| K983187 |
12/10/1998 |
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE |
MEDSOL CORP. |
ALEC S GOLDENBERG |
| K973011 |
02/25/1998 |
BPX80 BIO-PUMP (BPX80) |
MEDTRONIC BIO-MEDICUS, INC. |
THOMAS K JOHNSEN |
| K983297 |
12/18/1998 |
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE |
MEDTRONIC INSTENT, INC. |
NOEL MESSENGER |
| K974163 |
02/02/1998 |
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 |
MEDTRONIC MINIMED |
DON SELVEY |
| K983331 |
12/16/1998 |
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 |
MEDTRONIC PS MEDICAL |
JEFFREY HENDERSON |
| K971756 |
02/03/1998 |
MEDTRONIC MODEL 3998 LEAD |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K972906 |
02/06/1998 |
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K980973 |
12/10/1998 |
MEDTRONIC ANGIOGRAPHIC CATHETER |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARK CHARTIER |
| K970358 |
02/11/1998 |
ENSEMBLE CENTRAL STATION MONITOR |
MENNEN MEDICAL, INC. |
ALAN SCHWEBEL PH.D. |
| K974469 |
02/24/1998 |
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL |
MENTOR CORP. |
DONNA A CRAWFORD |
| K980050 |
02/27/1998 |
MENTOR SKIN PROTECTION PAD |
MENTOR CORP. |
DONNA A CRAWFORD |
| K983065 |
12/01/1998 |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM |
MENTOR CORP. |
DONNA A CRAWFORD |
| K983255 |
12/17/1998 |
MODIFICATION TO: PREMIER PLATINUM HPSA |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K982764 |
12/03/1998 |
PREMIER CRYPTOSPORIDIUM |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K974067 |
02/27/1998 |
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS REIGLE |
| K983976 |
12/30/1998 |
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM |
METAGEN, L.L.C. |
WESLEY D JOHNSON |
| K974782 |
02/24/1998 |
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES |
MEXPO INTL., INC. |
TIM THAI |
| K981554 |
12/22/1998 |
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) |
MICRA INSTRUMENTS LTD. |
JOHN A.K. BASKERVILLE |
| K974622 |
02/10/1998 |
DENTAL D |
MICRO DENTAL LABORATORIES |
NICOLAS E AZAR |
| K982543 |
12/11/1998 |
SILVERSTREAK HYDROPHILIC GUIDEWIRE |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K973669 |
02/06/1998 |
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) |
MICRO THERAPEUTICS, INC. |
BRAIN STRAUSS |
| K981922 |
12/10/1998 |
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CARL ANGLES |
| K983374 |
12/23/1998 |
AGATHA-A-H2010 |
MIDIAN INTL. |
CHRIS MONTALBANO |
| K983909 |
12/21/1998 |
MIR SPIROBANK SPIROMETER |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K974345 |
02/13/1998 |
MITEK KNOTLESS ANCHOR |
MITEK PRODUCTS |
EDWARD F KENT |
| K983401 |
12/15/1998 |
FRAMEWAVE WEB |
ML STRATEGIES, INC. |
ALLAN M GREEN |
| K980088 |
02/04/1998 |
T-UPTAKE MICROPLATE EIA |
MONOBIND |
FREDERICK R JEROME |
| K974385 |
02/19/1998 |
MLS ELECTROMYOGRAPHIC PREAMPLIFIER |
MOTION LAB SYSTEMS, INC. |
EDMUND CRAMP |
| K980060 |
02/25/1998 |
ECHOLINK |
MPACS, LLC. |
DENNIS D ROSCOE |
| K980229 |
02/27/1998 |
MSB TENS ELECTRODES (DISPOSABLE) |
MSB LTD. |
PETER MARKS |
| K983876 |
12/16/1998 |
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC |
MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND |
LARRY STEFFIER |
| K972795 |
02/20/1998 |
CARDIO-CARD MANAGEMENT SYSTEM II |
NASIFF ASSOC., INC. |
ROGER E NASIFF |
| K982728 |
12/07/1998 |
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C |
NELLCOR PURITAN BENNETT, INC. |
SHERYLL A MATHEWS |
| K983274 |
12/09/1998 |
STARTRACK INFANT GRAPHICS MONITOR |
NELLCOR PURITAN BENNETT, INC. |
DAVID A.C. GREEN |
| K982535 |
12/21/1998 |
INSIGHT DIAGNOSTIC IMAGING WORKSTATION |
NEO IMAGERY TECHNOLOGIES, INC. |
GARY J ALLSEBROOK |
| K974297 |
02/13/1998 |
GALILEO DISPOSABLE HYSTEROSCOPES |
NETOPTIX CORP. |
MARY MCNAMARA-CULLINANE |
| K974495 |
02/26/1998 |
NEUROAMP EEG AMPLIFIER |
NEUROCORP, LTD. |
EMIN ERALP |
| K974514 |
02/06/1998 |
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR |
NEUROMOTION, INC. |
BRAIN ZERB |
| K980475 |
12/16/1998 |
UNIPULSE CO2 SURGICAL LASER SYSTEM |
NIDEK, INC. |
KEN KATO |
| K983072 |
12/01/1998 |
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K974310 |
02/06/1998 |
NOMOS SLIT COLLIMATOR (BEAK) |
NOMOS CORP. |
MARVIN L SUSSMAN |
| K983470 |
12/22/1998 |
SUPER PORCELAIN STAIN- PURE WHITE |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
| K973459 |
02/13/1998 |
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS |
NORLAND CORP. |
TERRY SCHWALENBERG |
| K974444 |
02/13/1998 |
NUMASTATION |
NUMA, INC. |
KURT N LARSON |
| K974349 |
02/12/1998 |
OHMEDA-OHIO CARE PLUS INCUBATOR |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K982323 |
12/11/1998 |
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K984145 |
12/23/1998 |
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT |
OLYMPUS DIAGNOSTICA GMBH |
LAURA STORMS-TYLER |
| K983811 |
12/24/1998 |
UNIPOLAR OPTICAL BIOPSY FORCEPS |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
| K983730 |
12/11/1998 |
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K983725 |
12/07/1998 |
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K981917 |
12/07/1998 |
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
OON CORP. RESOURCES |
CLEMENT K.K OON |
| K974522 |
02/25/1998 |
3D I-SCAN |
OPHTHALMIC TECHNOLOGIES, INC. |
GEORGE MYERS |
| K973750 |
02/13/1998 |
STC CANNABINOIDS MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K984185 |
12/16/1998 |
MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K974566 |
02/24/1998 |
MDA SIMPLASTIN HTF |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K983267 |
12/30/1998 |
DIGORA FOR WINDOWS 2.0 |
ORION CORPORATION SOREDEX |
KAI LANER |
| K983031 |
12/18/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K983990 |
12/29/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K984011 |
12/07/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K974406 |
02/18/1998 |
ORTHOPLAN |
ORTHO-GRAPHICS, INC. |
PETER M STEVENS |
| K972326 |
02/06/1998 |
PEBA ANCHOR/SUTURE COMBINATION |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
JEFFREY B SKIBA |
| K983169 |
12/16/1998 |
POLYMER THREADED ANCHOR |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
JEFFRY B SKIBA |
| K983881 |
12/04/1998 |
COBRA EXTERNAL FIXATOR |
ORTHOPAEDIC INNOVATIONS, INC. |
TODD J HEIN |
| K983353 |
12/18/1998 |
SCS SPINAL SYSTEM |
ORTHOTEC, INC. |
DAVID W SCHLERF |
| K973318 |
02/19/1998 |
MOBIMED SYSTEM, (PEGASUS AND POLARIS) |
ORTIVUS US, INC. |
CONSTANCE G BUNDY |
| K974506 |
02/27/1998 |
LSF HA COATED TRIAD TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAN SON |
| K983165 |
12/03/1998 |
OSTEO 4.0MM CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTTON |
| K984353 |
12/16/1998 |
OSTEO 9MM IC TIBIAL NAIL |
OSTEONICS CORP. |
KATE SUTTON |
| K983508 |
12/07/1998 |
OSTEO COMPRESSION CONDYLE SCREW SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983382 |
12/11/1998 |
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983870 |
12/02/1998 |
OSTEONICS RESTORATION HA HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| K974556 |
02/27/1998 |
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM |
OSTEONICS CORP. |
DONNA S WILSON |
| K983502 |
12/16/1998 |
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K984302 |
12/18/1998 |
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS |
OSTEONICS CORP. |
KATE SUTTON |
| K983226 |
12/04/1998 |
OSTEONICS X CEMENTED HIP STEM SERIES |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983352 |
12/11/1998 |
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983351 |
12/11/1998 |
ILO292 DP ECHOPORT PLUS OAE SYSTEM |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983350 |
12/11/1998 |
ILO292 DP ECHOPORT PLUS OAE SYSTEM |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983974 |
12/21/1998 |
OWEN MUMFORD 3ML AUTOPEN |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K982275 |
12/04/1998 |
RAPPORT V.T.D. |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K983718 |
12/11/1998 |
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K974853 |
02/09/1998 |
LATEX (POWDER FREE) LOW PROTEIN |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
| K982897 |
12/23/1998 |
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K972814 |
02/23/1998 |
LOCATOR MODEL 4036 |
PACESETTER, INC. |
BETTY M JOHNSON |
| K984129 |
12/01/1998 |
COAGULATION CONTROL LEVEL 1 (NORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K984130 |
12/01/1998 |
COAGULATION CONTROL LEVEL 2 (ABNORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K984131 |
12/01/1998 |
COAGULATION CONTROL LEVEL 3 (ABNORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K983731 |
12/21/1998 |
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE |
PALL MEDICAL |
ROBERT A DICKSTEIN |
| K974635 |
02/04/1998 |
PARAGON LENS CARE |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K983413 |
12/21/1998 |
MODEL MS-1 HANDPIECE |
PARKELL, INC. |
NELSON J GENDUSA |
| K974362 |
02/12/1998 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K974082 |
02/27/1998 |
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE |
PERFORMANCE PLUS, INC. |
CAROLANN KOTULA |
| K974629 |
02/10/1998 |
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS |
PERSONAL PRODUCTS CO. |
RALPH PETRONE |
| K983729 |
12/11/1998 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
BOB CHAN |
| K974582 |
02/04/1998 |
QUICKSCREEN ONE STEP PCP SCREENING TEST |
PHAMATECH |
CARL A MONGIOVI |
| K974580 |
02/09/1998 |
ALLERGEN IMMUNOCAP F256,F245,F207,F202 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K974350 |
02/09/1998 |
ALLERGAN IMMUNO CAP M4, M8, K70 |
PHARMACIA, INC. |
KAREN E MATIS |
| K974180 |
02/24/1998 |
STERI-TAMP |
PHARMACY, INC. |
ED RANSOM |
| K983877 |
12/21/1998 |
PHILIPS INTEGRIS 3D RA OPTION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K983821 |
12/11/1998 |
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K974530 |
02/06/1998 |
DUFFUSION-WEIGHTED MR IMAGING PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K984111 |
12/11/1998 |
FV-RF |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL J HAYES |
| K983342 |
12/21/1998 |
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K984401 |
12/30/1998 |
NEUROMAG VECTORVIEW |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K974096 |
12/08/1998 |
CRX DIAMOND VALVE |
PHOENIX BIOMEDICAL CORP. |
DAVID KUNIN |
| K983477 |
12/22/1998 |
SUPER SEAL |
PHOENIX DENTAL, INC. |
ROBERT A CHERBA |
| K974287 |
02/10/1998 |
FM RECEIVER - AUDITORY TRAINER |
PHONIC EAR, INC. |
ROBERT L REINKE |
| K974658 |
02/25/1998 |
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT |
PHONIC EAR, INC. |
ROBERT L REINKE |
| K974250 |
02/11/1998 |
VERSASTAT MULTIPOLAR SCISSORS AND CABLES |
PILLING WECK, INC. |
RICHARD G JONES |
| K974409 |
02/19/1998 |
FRIEDL GLIDING NAIL SYSTEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K974466 |
02/19/1998 |
BOSTON ADVANCE CLEANER |
POLYMER TECHNOLOGY CORP. |
DOGULAS J FORTUNATO |
| K973542 |
02/10/1998 |
MASKY |
PRESSING DI MONTICELLI RAG. STEFANO |
THOMAS MADDUX |
| K983501 |
12/18/1998 |
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K972158 |
02/20/1998 |
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
PRINCETON REGULATORY ASSOC. |
THOMAS BECZE |
| K973191 |
02/13/1998 |
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM |
PULMONX |
ROBERT KOTMEL |
| K974398 |
02/18/1998 |
PULPDENT CAVITY VARNISH |
PULPDENT CORP. |
KENNETH J BERK |
| K984379 |
12/10/1998 |
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM |
PURITAN BENNETT CORP. |
ROBBIE WALSH |
| K984535 |
12/28/1998 |
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION |
PURITAN BENNETT CORP. |
ANN-MARIE BUTLER |
| K972991 |
12/03/1998 |
MONITOR ONE NDX |
QMED, INC. |
JOSEPH HANNA |
| K971710 |
02/27/1998 |
ULTRACON ULTRAFILTRATOR |
QUANTIC BIOMEDICAL, INC. |
ANDREW G HOOD |
| K984099 |
12/10/1998 |
QBC CENTRIFUGAL HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K981643 |
12/14/1998 |
RTM DVT PROSOFT CUFF MODEL NUMBER PS100 |
R.T. MEDICAL SERVICES, INC. |
KAREN L DIEHL |
| K982791 |
12/30/1998 |
ROCS TPS |
RADIATION ONCOLOGY COMPUTER SYSTEMS |
CHARLENE NEBLETT |
| K980130 |
02/09/1998 |
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K984245 |
12/18/1998 |
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS |
RADIONICS, INC. |
KEVIN J O'CONNELL |
| K982549 |
12/30/1998 |
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC |
RADIONICS, INC. |
DAVID CROMWICK |
| K974607 |
02/02/1998 |
RANDOX CALCIUM |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K974606 |
02/12/1998 |
RANDOX MAGNESIUM |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K974326 |
02/09/1998 |
LATEX CONDOMS (NATURAL COLOUR) |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
RAVI REDDY |
| K974324 |
02/09/1998 |
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
RAVI REDDY |
| K974323 |
02/10/1998 |
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
RAVI REDDY |
| K974064 |
12/07/1998 |
MICRO X RESIDUAL TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
WALTER JANSEN |
| K980069 |
02/12/1998 |
VANISHPOINT SYRINGE |
RETRACTABLE TECHNOLOGIES, INC. |
TERANCE GRISSO |
| K983236 |
12/04/1998 |
BIPOLAR HF CABLE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983279 |
12/02/1998 |
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983628 |
12/11/1998 |
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983871 |
12/01/1998 |
RITA MODEL 70 ELECTROSURGICAL PROBE |
RITA MEDICAL SYSTEMS |
DAVID A TUCKER |
| K983555 |
12/15/1998 |
ABUSCREEN ONLINE BENZ 200 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983556 |
12/15/1998 |
ABUSCREEN ONLINE BENZ 300 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983697 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983699 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983701 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983703 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983700 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K973718 |
12/15/1998 |
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K972856 |
02/11/1998 |
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS |
ROCKET MEDICAL PLC |
L. TODD |
| K981678 |
12/11/1998 |
STRATA, MODEL V.O.95 |
ROSSES MEDICAL SYSTEMS |
RENE SPECTOR |
| K980107 |
02/19/1998 |
RUNCH INDUSTRIAL WHEELCHAIR |
RUNCH GROUP USA, INC. |
HILARIO E MATA |
| K982614 |
12/04/1998 |
RUSCH POLYFLEX STENT KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K972423 |
02/13/1998 |
RUSCH TRACHEOFIX-SET |
RUSCH INTL. |
JAMES R WHITNEY |
| K972877 |
02/26/1998 |
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K972900 |
02/26/1998 |
ULTRASAFE MODEL T200 INJECTOR |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K980490 |
02/24/1998 |
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS |
SAGE PRODUCTS, INC. |
CHRISTINE FALKSTROM |
| K983403 |
12/17/1998 |
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER |
SALTER LABS |
DUANE KAZAL |
| K980205 |
02/12/1998 |
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST |
SAN DIEGO BIOTECH |
CHAI BUNYAGIDJ, PH.D. |
| K982661 |
12/11/1998 |
CDR - PAN MODEL 4700 |
SCHICK TECHNOLOGIES, INC. |
ENRICO RENZI |
| K973867 |
02/10/1998 |
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
| K983305 |
12/17/1998 |
SCI-PHARM DESENSITIZING VARNISH |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K974253 |
02/25/1998 |
CPD COMMANDER |
SCIERAN TECHNOLOGIES, INC. |
ROD ROSS |
| K980085 |
02/24/1998 |
PHACO COMMANDER |
SCIERAN TECHNOLOGIES, INC. |
GARY S MOCNIK |
| K974559 |
02/23/1998 |
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS |
SCIMED LIFE SYSTEMS, INC. |
MELANIE RASKA |
| K974684 |
02/19/1998 |
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER |
SCIMED LIFE SYSTEMS, INC. |
MELANIE RASKA |
| K973996 |
02/04/1998 |
CLEARLINE PLUS, DENTAL WATERLINE FILTER |
SCITECH SOLUTIONS, INC. |
CLIVE DEFTY |
| K983630 |
12/11/1998 |
SEARE BIOMEDICAL SILICONE RODS |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE, JR. |
| K983792 |
12/11/1998 |
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE JR |
| K983468 |
12/17/1998 |
FASTTAKE ADAPTER, MODEL # P/N 020-072-01 |
SELFCARE, INC. |
BETTY LANE |
| K974832 |
02/11/1998 |
POWDERFREE LATEX EXAMINATION GLOVES |
SERVICOM SERVICES SDN BHD |
N.S KUMAR |
| K973938 |
02/04/1998 |
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER |
SFRI, INC. |
GERALD ODSTRCHEL |
| K982885 |
12/04/1998 |
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
DON MORRIS |
| K983645 |
12/04/1998 |
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K974492 |
02/26/1998 |
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JACQUELINE E M. EMERY |
| K974480 |
02/24/1998 |
SILIMED CALF IMPLANT |
SILIMED, LLC. |
E J SMITH |
| K974482 |
02/24/1998 |
SILIMED GLUTEAL IMPLANT |
SILIMED, LLC. |
E J SMITH |
| K982316 |
12/16/1998 |
LASEAWAY ALEXANDRITE LASER SYSTEM |
SILVER CREEK, INC. |
LORNA K LINVILLE |
| K974661 |
02/11/1998 |
0.2 U BACTERIAL FILTER |
SIMS DELTEC, INC. |
LISA STONE |
| K980466 |
02/24/1998 |
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
| K974710 |
02/25/1998 |
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE |
SINOCHEM NINGBO LATEX GLOVES FACTORY |
JANNA P TUCKER |
| K983242 |
12/11/1998 |
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HAMEON-HEYER |
| K974372 |
02/05/1998 |
AIR OXYGE MIXER |
SK MED |
DIPAK GHOSH |
| K983964 |
12/09/1998 |
BATCH #6060 CONDUCTIVE GEL |
SKYLARK DEVICE CO., LTD. |
GEORGE CHEN |
| K981449 |
12/11/1998 |
SD-956 ULTRASOUND THERAPY |
SKYLARK DEVICE CO., LTD. |
GEORGE K C CHEN |
| K983210 |
12/10/1998 |
ALGISITE M |
SMITH & NEPHEW, INC. |
JIM G IRVIN |
| K983942 |
12/04/1998 |
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP |
SMITH & NEPHEW, INC. |
|
| K974531 |
02/12/1998 |
SNORE-EZZER |
SNORE - EZZER |
ROBERT A GALL |
| K980184 |
12/18/1998 |
CD SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K983672 |
12/16/1998 |
DYNA-LOK SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K972798 |
02/24/1998 |
DYNEMO 3000 |
SOMETEC, INC. |
JEAN-LUC BOULNOIS |
| K963758 |
02/20/1998 |
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE |
SORIN BIOMEDICAL, INC. |
SUSAN J REIMERS |
| K963759 |
02/20/1998 |
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS |
SORIN BIOMEDICAL, INC. |
SUSAN J REIMERS |
| K973596 |
02/03/1998 |
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE |
SPACELABS MEDICAL, INC. |
RUSS GARRISON |
| K973169 |
02/20/1998 |
PRESSURE GUARD SITE SELECT (A) |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
WANDA TOTTON |
| K972486 |
02/20/1998 |
PRESSUREGUARD IV |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
WANDA TOTTON |
| K974654 |
02/24/1998 |
SILICONE BLOCKS |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K974209 |
02/06/1998 |
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER |
SPECIALTY SURGICAL PRODUCTS, INC. |
JAN VARNER |
| K980039 |
02/09/1998 |
POWDERED GREEN LATEX EXAMINATION GLOVES |
SRI JOHANI SDN. BHD. |
LIM L AIK |
| K980038 |
02/09/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES |
SRI JOHANI SDN. BHD. |
LIM L AIK |
| K980037 |
02/09/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) |
SRI JOHANI SDN. BHD. |
LIM L AIK |
| K984196 |
12/11/1998 |
MODIFICATION TO PROWESS PRO-SIM |
SSGI PROWESS SYSTEMS |
ROBERT J MORTON |
| K983129 |
12/04/1998 |
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) |
STAAR SURGICAL CO. |
STEVEN L ZIEMBA |
| K974429 |
02/18/1998 |
RAPET CRP |
STANBIO LABORATORY |
KIRK JOHNSON |
| K974370 |
02/17/1998 |
RAPET RF |
STANBIO LABORATORY |
KIRK JOHNSON |
| K980183 |
02/26/1998 |
PROMAX SURGICAL DRAPES AND COVERS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K973223 |
02/18/1998 |
STELLAR MODEL HS-04 |
STELLAR MEDICAL CORP. |
T. WHIT ATHEY |
| K983947 |
12/04/1998 |
AMERSE 2 |
STERIS Corporation |
MICHAEL G SARLI |
| K980369 |
02/17/1998 |
T.B.Q. RTU |
STERIS Corporation |
MICHAEL G SARLI |
| K980220 |
02/13/1998 |
IISYS PACS SYSTEM |
STERLING DIAGNOSTIC IMAGING, INC. |
TIMOTHY W CAPEHART |
| K972321 |
02/27/1998 |
S3 MAST PUMP |
STOECKERT INSTRUMENTE |
ROSINA ROBINSON |
| K983557 |
12/18/1998 |
STRYKER WEDGE SUTURE ANCHOR |
Stryker Endoscopy |
TODD MILLER |
| K983153 |
12/04/1998 |
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS |
SULZER ORTHOPEDICS, INC. |
DENISE CUCHENE |
| K983733 |
12/18/1998 |
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K980675 |
12/22/1998 |
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME |
SUMMIT TECHNOLOGY, INC. |
Eric Ankerud |
| K983320 |
12/11/1998 |
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS |
SURETEX PROPHYLACTICS (INDIA) LTD. |
V.V. RAMANA RAO |
| K980156 |
02/27/1998 |
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS |
SURGICAL LASER TECHNOLOGIES, INC. |
MONICA FERRANTE |
| K983397 |
12/04/1998 |
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K982212 |
12/02/1998 |
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 |
SYNERGETICS, INC. |
KURT GAMPP |
| K974909 |
02/24/1998 |
SYNERMED CREATININE REAGENT KIT |
SYNERMED INTL., INC. |
MARCIA J ARENTZ |
| K983495 |
12/16/1998 |
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983873 |
12/30/1998 |
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983757 |
12/04/1998 |
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983485 |
12/21/1998 |
SYNTHES 1.3 MM SELF-DRILLING SCREW |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K974537 |
02/18/1998 |
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K983530 |
12/16/1998 |
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM |
SYNTHES (USA) |
JONATHAN M GILBERT |
| K974554 |
02/24/1998 |
SYNTHES RESORBABLE FIXATION SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K983766 |
12/18/1998 |
SYNTHES SYNMESH |
SYNTHES (USA) |
JAMES MCCRACKEN |
| K974712 |
02/12/1998 |
QUIKSTRIP ONE STEP BARBITURATE TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
| K971981 |
12/22/1998 |
LS SERIES 200 FLOVISION SYSTEM |
SYSTAM |
ED RANSOM |
| K974485 |
02/24/1998 |
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION |
SZABOCSIK AND ASSOC. |
JOHN M SZABOCSIK |
| K981363 |
12/22/1998 |
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST |
TCPI, INC. |
JEFFREY BOLTS |
| K974307 |
02/13/1998 |
RTR-2000/RTR-4000 |
TERARECON, INC. |
TIM FRANDSEN |
| K972657 |
02/02/1998 |
ULTRAMIST 2000 |
TEXAS MEDICAL INDUSTRIES, INC. |
STEVE HARLOW |
| K981912 |
12/04/1998 |
HUMAN IGA SUBCLASS BNII COMBI KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K973373 |
02/26/1998 |
PREVENT I |
THE BUZZZ CORP. |
KEN CASEY |
| K974280 |
02/20/1998 |
ABUTMENT - COMPLETE |
THE IMPLANT CENTER OF THE PALM BEACHES |
JACK T KRAUSER |
| K971593 |
02/26/1998 |
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT |
THE SILCRAFT CORP. |
HOWARD M HOLSTEIN |
| K971592 |
02/26/1998 |
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM |
THE SILCRAFT CORP. |
HOWARD M HOLSTEIN |
| K983622 |
12/30/1998 |
BODYFORM THORACO-LUMBAR FIXATION SYSTEM |
THEKEN SURGICAL,LLC |
LUKAS EISERMANN |
| K981171 |
12/02/1998 |
ERADIC-ALL |
THERATECHNOLOGIES, INC. |
ANDRE DE VILLERS |
| K983917 |
12/04/1998 |
THERATRON ELITE |
THERATRONICS, INC. |
E.S. MARTELL |
| K984384 |
12/23/1998 |
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 |
THERMO BIOANALYSIS CORP. |
JANET A MCGRATH |
| K974208 |
02/03/1998 |
TYTRON C-3000 |
TITRONICS RESEARCH & DEVELOPMENT CO. |
JOSEPH R TITONE |
| K980051 |
02/24/1998 |
PALFIQUE ESTELITE PASTE |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K983825 |
12/04/1998 |
NITRILE LATEX POWDER FREE EXAMINATION GLOVE |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K983816 |
12/04/1998 |
NITRILE LATEX POWDERED EXAMINATION GLOVE |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K970829 |
12/22/1998 |
PHUSIS ABSORBABLE INTERFERENCE SCREW |
TORNIER |
DAVID W SCHLERF |
| K972771 |
02/11/1998 |
PHASED ARRAY TRANSDUCER - - PVF -375DT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
STEVEN M KAY |
| K983514 |
12/23/1998 |
POSITRON OPTION, MODEL NSCO-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DONNELLE KRAJEWSKI |
| K983516 |
12/23/1998 |
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DONELLE KRAJEWSKI |
| K984359 |
12/23/1998 |
AIA-PACK TROPONIN I ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K980028 |
02/02/1998 |
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
David Johnston |
| K984414 |
12/30/1998 |
XRE COLLIMATOR WITH SPECTRAL FILTER |
TREX MEDICAL CORP. |
WAYNE V LOOMER |
| K973172 |
02/03/1998 |
RESPOSABLE BARE FIBERS |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K974238 |
02/04/1998 |
DENTAL TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K974413 |
02/02/1998 |
PERMAFLO |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K974432 |
02/09/1998 |
ULTRAGUIDE 1000 |
ULTRAGUIDE LTD. |
GEORGE H MYERS |
| K981946 |
12/10/1998 |
CLEARVIEW IM |
UNIPATH LTD. |
Louise Roberts |
| K973692 |
02/09/1998 |
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE |
UNITED BIOTECH, INC. |
CHIN SHU CHENG |
| K984342 |
12/30/1998 |
ANTERIOR CERVICAL PLATING SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
KAREN F JURCZAK |
| K974213 |
02/04/1998 |
AURORA TITANIUM SPINAL ROD SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON MURPHY |
| K983293 |
12/16/1998 |
AUTO SUTURE LAPAROSCOPES DEVICE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JAMIE YIEH |
| K983904 |
12/22/1998 |
ROGOZINSKI SPINAL ROD SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K983899 |
12/22/1998 |
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K982140 |
12/08/1998 |
CLINICAL ELECTRONIC THERMOMETER |
VALEO CORP. |
PHIL ZULUETA |
| K974402 |
02/19/1998 |
3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974403 |
02/19/1998 |
3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974856 |
02/27/1998 |
3.25MM SIMPLER THREADED DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974404 |
02/19/1998 |
4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974401 |
02/23/1998 |
4.0MM SIMPLER ONE THREADED DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974857 |
02/27/1998 |
4.0MM SIMPLER THREADED DENTAL IMPLANT |
VANCOUVER IMPLANT RESOURCES, INC. |
HAROLD BERGMAN |
| K974215 |
02/19/1998 |
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET |
VETCO, INC. |
JEFF SHAPIRO |
| K983529 |
12/31/1998 |
INSTATRAK 3000 |
VISUALIZATION TECHNOLOGY, INC. |
MARY MCNAMARA-CULLINANE |
| K982901 |
12/21/1998 |
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K983716 |
12/23/1998 |
VITALCARE DISPOSABLE VAGINAL SPECULUM |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K974521 |
02/20/1998 |
VNUS CLOSURE SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
TOM HOLDYCH |
| K974772 |
02/10/1998 |
UFI GEL C |
VOCO GMBH |
EVAN DICK |
| K983525 |
12/10/1998 |
GORE REVOX THYROPLASTY IMPLANT |
W.L. GORE & ASSOCIATES,INC |
JOHN NICHOLSON |
| K973080 |
02/23/1998 |
SURGICAL VASCULAR CLAMP |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K983663 |
12/18/1998 |
C.T.M. MOBILITY SCOOTER, MODEL # HS-666 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K983662 |
12/18/1998 |
C.T.M. MOBILITY SCOOTER, MODEL # HS-686 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K980180 |
02/12/1998 |
2700 SAMPLE MANAGER |
WATERS CORPORATION |
VIRGINIA L CORBIN |
| K980281 |
02/27/1998 |
WELCH ALLYN XENON 300 LIGHT SOURCE |
WELCH ALLYN, INC. |
KATHY LOWTHER |
| K973734 |
02/05/1998 |
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION |
WELCON, INC. |
PAMELA PAPINEAU |
| K982344 |
12/22/1998 |
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS |
WESLEY JESSEN CORP. |
JOSEPH FOOS |
| K983833 |
12/10/1998 |
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE |
WESTAIM BIOMEDICAL, INC. |
JONATHAN S KAHAN |
| K974169 |
02/17/1998 |
WIELISA ANTI-GBM TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER |
| K974166 |
02/17/1998 |
WIELISA MPO ANCA TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER |
| K974167 |
02/17/1998 |
WIELISA PR-3 ANCA TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER |
| K984157 |
12/08/1998 |
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K980333 |
02/18/1998 |
RELIEFBAND |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
| K974435 |
02/19/1998 |
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DAN REGAN |
| K983765 |
12/11/1998 |
INJECTION NEEDLE PROBE/DEVICE-TUNIS |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K983200 |
12/11/1998 |
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K974484 |
02/10/1998 |
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K984173 |
12/22/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984347 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984175 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983803 |
12/14/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983804 |
12/08/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983801 |
12/10/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984315 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K982981 |
12/17/1998 |
NEW ZIMMER SHOULDER SYSTEM |
ZIMMER, INC. |
LAURA D WILLIAMS |
