| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K000968 |
05/03/2000 |
3181 DUO DELIVERY SYSTEM |
A-DEC, INC. |
LOVENA STANDRIDGE |
| K000966 |
05/03/2000 |
4631 DUO DELIVERY SYSTEM |
A-DEC, INC. |
LOVENA STANDRIDGE |
| K000967 |
05/03/2000 |
4635 ASSISTANT'S INSTRUMENTATION |
A-DEC, INC. |
LOVENA STANDRIDGE |
| K992592 |
05/04/2000 |
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 |
A-MED SYSTEMS, INC. |
ROBERTA THOMPSON |
| K000596 |
05/22/2000 |
ETEST GATIFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K000298 |
05/18/2000 |
ETEST MOXIFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K994433 |
05/05/2000 |
CONNECT DATA MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
EVE A CONNER |
| K992085 |
05/25/2000 |
ABBOTT IMX GLYCATED HEMOGLOBIN II |
ABBOTT LABORATORIES |
KATHERINE M WORTLEY |
| K991103 |
05/31/2000 |
MODIFICATION TO ACIST CL 100H |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K000932 |
05/17/2000 |
ARACHNOPHLEBECTOMY NEEDLE |
ADVANCED MEDICAL PRODUCTS, INC. |
CHARLES H KYPER |
| K001381 |
05/17/2000 |
CIDEX OPA SOLUTION |
ADVANCED STERILIZATION PRODUCTS |
NEELU MEDHEKAR |
| K000547 |
05/03/2000 |
ATR TECNIKA |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. |
DANIELE POLI |
| K000775 |
05/17/2000 |
HEART 2005 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
| K001330 |
05/30/2000 |
SOVEREIGN BIPOLAR INSTRUMENTS |
AESCULAP, INC. |
LIA S JONES |
| K001308 |
05/17/2000 |
MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW |
AGILENT TECHNOLOGIES |
GRETEL LUMLEY |
| K001333 |
05/17/2000 |
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI |
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
EGON PFEIL |
| K994188 |
05/19/2000 |
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 |
AGILENT TECHNOLOGIES, GMBH |
HERBERT VAN DYK |
| K001057 |
05/03/2000 |
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K001348 |
05/17/2000 |
ST/AR ST AND ARRHYTHMIA SOFTWARE |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K001013 |
05/16/2000 |
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY |
AIRSEP CORP. |
PETER WEISENBORN |
| K000162 |
05/12/2000 |
METRISCAN BONE DENSITY SYSTEM |
ALARA, INC. |
DIANE M KING |
| K000637 |
05/19/2000 |
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) |
ALCON LABORATORIES, INC. |
S.K. MCGARVEY |
| K001321 |
05/16/2000 |
ALL-PRO 2010 |
ALL-PRO IMAGING CORP. |
JOSEPH CAREY |
| K001141 |
05/09/2000 |
POWDER FREE STERILE LATEX EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K993278 |
05/17/2000 |
AMBU NEONATE SILICONE RESUSCITATOR |
AMBU, INC. |
SANJAY PARIKH |
| K994362 |
05/11/2000 |
HEADLAMP HL2000. |
ANGIOLAZ, INC. |
ROBERT ALLMAN |
| K001239 |
05/15/2000 |
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K000545 |
05/02/2000 |
SENTRY EXPANDING INTRODUCER SHEATH (EIS) |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K001079 |
05/01/2000 |
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO |
ARJO, INC. |
DAVID INSCO |
| K001212 |
05/09/2000 |
TROJAN EXTRA LARGE LATEX CONDOM |
ARMKEL, LLC. |
STEPHEN C KOLAKOWSKY |
| K000729 |
05/19/2000 |
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K000506 |
05/01/2000 |
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B |
ARTHREX, INC. |
VERNON BROWN |
| K001302 |
05/30/2000 |
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K000778 |
05/03/2000 |
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K993592 |
05/17/2000 |
AXIOM MULTIPURPOSE WOUND DRAIN |
AXIOM MEDICAL, INC. |
RIDWAN HARDY |
| K000960 |
05/26/2000 |
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 |
BARZELL-WHITMORE MAROON BELLS, INC. |
ART WARD |
| K993816 |
05/04/2000 |
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD |
BAXTER EDWARDS |
DIANE PETERSON |
| K000903 |
05/18/2000 |
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
FREDRICK CLERIE |
| K000921 |
05/18/2000 |
BAYER ADVIA IMS SYSTEM; 200 + 3 |
BAYER CORP. |
FREDRICK CLERIE |
| K000897 |
05/05/2000 |
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE |
BD Biosciences |
CINDY MORROW |
| K000611 |
05/18/2000 |
STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER |
BD Biosciences |
JO-ANN E FABILA |
| K000121 |
05/17/2000 |
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K000606 |
05/05/2000 |
SYNCHRON SYSTEMS AMPHETAMINE REAGENT |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K000799 |
05/17/2000 |
BELMONT UNIT, MODEL 2000 SERIES |
BELMONT EQUIPMENT CORP. |
JOHN E COLLINS |
| K000108 |
05/23/2000 |
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 |
BHK HOLDING |
ART WARD |
| K001373 |
05/25/2000 |
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 |
BIO-RAD |
ELIZABETH PLATT |
| K993319 |
05/22/2000 |
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 |
BIOMERIEUX, INC. |
ANNA DEMARINIS |
| K993438 |
05/18/2000 |
METAL ON METAL ACETABULAR SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K000760 |
05/23/2000 |
REACH FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K000248 |
05/05/2000 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
AMY WALTERS |
| K000190 |
05/05/2000 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
SIGI CARON |
| K000332 |
05/04/2000 |
NOGA CARDIAC NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
AMY WALTERS |
| K001139 |
05/10/2000 |
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M |
BIOSENSE WEBSTER, INC. |
MARY ADAMS |
| K000681 |
05/03/2000 |
AU5, AU6 |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K000438 |
05/03/2000 |
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER |
BIOSURGICAL CORP. |
TERRY LAAS |
| K000633 |
05/25/2000 |
SYNTHETIC GLASS BONE GRAFT MATERIAL |
BLUE SKY BIO |
RITA GIEBEL |
| K000510 |
05/15/2000 |
ART-M1, MODEL M1-1-ART-A1 |
BONART CO. LTD. |
BANKSON TSAI |
| K992320 |
05/18/2000 |
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
BOSTON SCIENTIFIC CORP. |
RONALD W BENNETT |
| K000308 |
05/19/2000 |
WALLSTENT BILIARY ENDOPROSTHESIS |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K000281 |
05/12/2000 |
WALLSTENT ENTERNAL PROSTHESIS |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K001083 |
05/03/2000 |
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K000520 |
05/16/2000 |
C-IT |
BREGAS AB |
PAUL KRILL |
| K000519 |
05/01/2000 |
GLUCANPRO |
BRENNEN MEDICAL, INC. |
PHIL LAWIN |
| K000518 |
05/01/2000 |
MACROPRO GEL |
BRENNEN MEDICAL, INC. |
PHIL LAWIN |
| K000639 |
05/25/2000 |
VISIONARY 2000 |
BURTON MEDICAL PRODUCTS CORP. |
DORIAN SWARTZ |
| K994260 |
05/26/2000 |
CANDELA GENTLELASE GL DERMATOLOGICAL LASER |
CANDELA CORP. |
JAY CAPLAN |
| K000609 |
05/23/2000 |
CARDTEL, MODEL NT-100 |
CARDIAC TELECOMMUNICATIONS |
J. HARVEY KNAUSS |
| K001100 |
05/05/2000 |
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRIAN PARK |
| K001368 |
05/12/2000 |
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER |
CARMEL PHARMA AB. |
KJELL ANDREASSON |
| K000686 |
05/25/2000 |
KROM-ALGINATE AND ALGINATE PLUS |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K000770 |
05/16/2000 |
PROVIEW MEDICAL IMAGE DISPLAY MODULE |
CERNER CORP. |
SHELLEY LOOBY |
| K000607 |
05/15/2000 |
SOLO-CARE BRAND HARD SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K000368 |
05/04/2000 |
EYECAP IMAGING SYSTEM |
CLEMENT CLARKE INTL., LTD. |
M.J. WILKINSON |
| K001042 |
05/23/2000 |
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
CHEE YONG FOO |
| K001090 |
05/19/2000 |
METHAFILCON A |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K001089 |
05/19/2000 |
POLYMACON |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K000579 |
05/03/2000 |
TEMPO AQUA ANGIOGRAPHIC CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K000500 |
05/26/2000 |
DINAMAP ADVANCED NIBP MODULE |
CRITIKON COMPANY, L.L.C. |
THOMAS J ENGLISH |
| K000973 |
05/26/2000 |
BEHRING COAGULATION SYSTEM (BCS) |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K001256 |
05/24/2000 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
DONNA A WOLF |
| K001145 |
05/11/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K994334 |
05/15/2000 |
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX |
DAIG CORP. |
TODD KORNMANN |
| K001198 |
05/12/2000 |
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET |
DATASCOPE CORP. |
JOANN WOLF |
| K000706 |
05/11/2000 |
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
| K000894 |
05/19/2000 |
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO |
DENTAL VENTURES OF AMERICA, INC. |
ANTHONY SIRAGUSA |
| K000658 |
05/11/2000 |
ERS RADIAL HEAD REPLACEMENT |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K001451 |
05/18/2000 |
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
| K001086 |
05/18/2000 |
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K000982 |
05/01/2000 |
A100 AESTHETIC DIODE LASER |
DIOMED, INC. |
MAUREEN O'CONNELL |
| K000704 |
05/19/2000 |
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) |
DMC MEDICAL LTD. |
CHARMAINE HENDERSON |
| K001243 |
05/24/2000 |
DORNIER MEDILAS H |
DORNIER SURGICAL PRODUCTS, INC. |
JOE D BROWN |
| K001030 |
05/11/2000 |
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S |
DYMEDIX, INC. |
Gary Syring |
| K001263 |
05/05/2000 |
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 |
E S C SHARPLAN |
ZVI LADIN |
| K001264 |
05/30/2000 |
EAGLE ENDO SPECIMEN RETRIEVAL BAG |
EAGLE ENDOSCOPIC, INC. |
JOHN MAYALL |
| K001358 |
05/23/2000 |
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K000556 |
05/17/2000 |
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K000958 |
05/24/2000 |
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS |
ELAN HOLDINGS, INC. |
WYNN STOKING |
| K000900 |
05/02/2000 |
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K000480 |
05/02/2000 |
ACTIVE ELECTRODE MONITORING SYSTEM |
ELECTROSCOPE, INC. |
LYNNE ARONSON |
| K001253 |
05/26/2000 |
SURGITRON IEC II |
ELLMAN INTL., INC. |
FRANK LIN |
| K993841 |
05/04/2000 |
CEMSTOP CEMENT RESTRICTOR |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K000521 |
05/10/2000 |
KEYSTONE HIP |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K000590 |
05/11/2000 |
LATERAL PIVOT INSERT |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K001024 |
05/23/2000 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DE LOS SANTOS |
| K000215 |
05/26/2000 |
SWIVEL ELBOW |
ENGINEERED MEDICAL SYSTEMS |
BONNIE HOLLY |
| K993010 |
05/30/2000 |
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER |
ENVIRONMENTAL TECTONICS CORP. |
HOWARD M HOLSTEIN |
| K001220 |
05/16/2000 |
ENDOPATH SURESEAL REDUCER CAP |
ETHICON ENDO-SURGERY, INC. |
TAMIMA ITANI |
| K001122 |
05/23/2000 |
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH |
ETHICON, INC. |
GREGORY R JONES |
| K994098 |
05/23/2000 |
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. |
DOREEN FENG |
| K001335 |
05/18/2000 |
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED |
EXACTECH, INC. |
Lisa Simpson |
| K991293 |
05/05/2000 |
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR |
FISCHER MEDICAL TECHNOLOGIES, INC. |
RONALD SHORES |
| K001232 |
05/15/2000 |
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH J E PEREIRA |
| K000896 |
05/03/2000 |
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH J E PEREIRA |
| K000451 |
05/09/2000 |
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K000802 |
05/26/2000 |
SPIRAL IMAGING OPTION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K000395 |
05/03/2000 |
EINSTEIN PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K001267 |
05/12/2000 |
GE SYSTEM FIVE |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K001029 |
05/23/2000 |
GEIGER NEEDLE ADAPTER, MODEL 406 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K000779 |
05/18/2000 |
APEXPRO TELEMETRY SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K000645 |
05/24/2000 |
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
IAN MCDONALD |
| K000263 |
05/09/2000 |
GO MEDICAL BALLOON INFUSION SYSTEM |
GO MEDICAL INDUSTRIES PTY. LTD. |
GEORGE O'NEIL |
| K993732 |
05/15/2000 |
BVBLUE |
GRYPHUS DIAGNOSTICS, L.L.C. |
THOMAS M TSAKERIS |
| K001222 |
05/17/2000 |
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 |
GUIDANT CORP. |
MARGARET ANDERSON |
| K001224 |
05/17/2000 |
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 |
GUIDANT CORP. |
MARGARET ANDERSON |
| K001049 |
05/23/2000 |
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K993678 |
05/05/2000 |
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES |
HAEMOSCOPE CORP. |
ELI COHEN |
| K000380 |
05/03/2000 |
FOTOMASTER |
HAMILTON THORNE RESEARCH |
MEG D HAMILTON |
| K993760 |
05/15/2000 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K000303 |
05/16/2000 |
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB |
HEALTHCARE SERVICE AND SUPPLY |
RICK ROEDER |
| K994243 |
05/05/2000 |
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K992543 |
05/18/2000 |
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE |
HEWLETT-PACKARD CO. |
TERESA SKARR |
| K993991 |
05/30/2000 |
HM-930 ELECTROSURGICAL UNIT |
HILL-MED, INC. |
JHOANA VASQUEZ |
| K000630 |
05/12/2000 |
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM |
HOPKINS IMAGING SYSTEMS, INC. |
RICHARD HOPKINS |
| K000957 |
05/23/2000 |
HOFFMANN II EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K000965 |
05/11/2000 |
MULTI-AXIAL CROSS (MAC) CONNECTOR |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K000636 |
05/11/2000 |
STRYKER TRAUMA PLATING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K001272 |
05/11/2000 |
XIA SPINE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K001319 |
05/23/2000 |
XIA SPINE SYSTEM HOOKS |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K993355 |
05/24/2000 |
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 |
HUDSON RESPIRATORY CARE, INC. |
CHARLES MIERKIEWICZ |
| K000915 |
05/12/2000 |
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
CINDY SHOWALTER |
| K000472 |
05/10/2000 |
POSI-LINK |
ICU MEDICAL, INC. |
SALVADORE F PALOMARES |
| K001248 |
05/04/2000 |
MULTI-PULSE 2000 |
IMAGING SCIENCES INTL., INC. |
ROBERT E HAY |
| K001307 |
05/23/2000 |
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ |
IMPLEX CORP. |
JOHN SCHALAGO |
| K992668 |
05/26/2000 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K000485 |
05/12/2000 |
HYDRO2, HS-75 |
INNOVISION, INC. |
DON M WOODFORD |
| K001171 |
05/12/2000 |
DELTA 16 TACT |
INSTRUMENTARIUM IMAGING, INC. |
MAX LINDERT |
| K000405 |
05/17/2000 |
INTERCURE LTD. RESPI-LOW |
INTERCURE LTD. |
JONATHAN S KAHAN |
| K001257 |
05/18/2000 |
INTRACOIL STENT |
INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K984231 |
05/31/2000 |
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B |
INVASATEC |
KATE ANDERSON |
| K000939 |
05/04/2000 |
HTF-HEPES |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K000940 |
05/04/2000 |
HUMAN SERUM ALBUMIN (HSA) |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K000938 |
05/25/2000 |
IVC ONE MEDIUM |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K000937 |
05/25/2000 |
IVC TWO MEDIUM |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K993484 |
05/25/2000 |
Q-HTF, CAT# 2001 |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K980672 |
05/04/2000 |
SIMPLEX AIRBRATOR (SAB-7) |
IRT MANAGEMENT CORP. |
NICHOLAS G LEVANDOSKI, PH.D. |
| K000587 |
05/04/2000 |
SHUTTLE STOP |
ISOTIS NV |
CYNTHIA J.M. NOLTE |
| K000078 |
05/15/2000 |
JETLITE 4000 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K001260 |
05/17/2000 |
ALLROUND 55 LF |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K001196 |
05/11/2000 |
JEL BIOS 90 (CODE NAME RD-2401) |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K000738 |
05/26/2000 |
WHEELCHAIR, MODELS H001A, 4422 |
JACKSON COMPANY LLC. |
DEBORAH WEIMAN |
| K000805 |
05/04/2000 |
KAVO K.E.Y. LASER 1242 |
KAVO AMERICA |
JOHN FRANZ |
| K001043 |
05/19/2000 |
KAWASUMI LABORATORY BLOOD DRAWING KIT |
KAWASUMI LABORATORIES AMERICA, INC. |
JACK PAVLO |
| K000948 |
05/12/2000 |
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
ROGER GRAY |
| K990614 |
05/23/2000 |
HME-BOOSTER |
KING SYSTEMS CORP. |
CHARLES A BURT |
| K001190 |
05/23/2000 |
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
LIM KWAN HWA |
| K000320 |
05/02/2000 |
SONOS AIRES 600 (SA-600) |
KPI ULTRASOUND, LLC. |
STEVEN S MINN |
| K000663 |
05/02/2000 |
KRONNER LOW PROFILE SCOPE HOLDER |
KRONNER PROTOTYPES, INC. |
RICHARD KRONNER |
| K000950 |
05/12/2000 |
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 |
LABOTECT LABOR-TECHNIK GOTTINGEN |
ANGELIKA ALBRECHT |
| K001144 |
05/05/2000 |
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS |
LASERSIGHT TECHNOLOGIES, INC. |
SAM MIRZA |
| K001428 |
05/26/2000 |
OPTIMUM WETTING AND REWETTING DROP |
LOBOB LABORATORIES, INC. |
DANIEL J MANELLI |
| K001115 |
05/17/2000 |
ULTRA CATHETER SET |
LYCO ENTERPRISES, INC. |
ROBERT L CHILD |
| K000503 |
05/15/2000 |
MEDART 520 COOLING SYSTEM |
MEDART CORP. |
JAN K ENEMAERKE |
| K993815 |
05/11/2000 |
UNI-LASER 430 |
MEDART CORP. |
JAN K ENEMAERKE |
| K000328 |
05/09/2000 |
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP |
MEDEX, INC. |
CATHY CHENETSKI |
| K000926 |
05/15/2000 |
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER |
MEDICA CORP. |
Photios Makris |
| K993758 |
05/19/2000 |
PROAIR 3000 COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
SHOSHANA FRIEDMAN |
| K000693 |
05/16/2000 |
UMECO OPTIMA MULTILINE LASER SYSTEM |
MEDICAL LASER SOLUTIONS LLC. |
IAIN D MILLER |
| K991471 |
05/09/2000 |
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) |
MEDICULT A/S |
RONALD G LEONARDI |
| K991472 |
05/09/2000 |
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 |
MEDICULT A/S |
RONALD G LEONARDI |
| K991327 |
05/04/2000 |
MEDI-CULT FLUSHING MEDIUM |
MEDICULT A/S |
RONALD G LEONARDI |
| K991332 |
05/04/2000 |
MEDI-CULT SPERM PREPARATION - MEDIUM; |
MEDICULT A/S |
RONALD G LEONARDI |
| K001293 |
05/05/2000 |
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE |
MEDIMOP MEDICAL PROJECTS, LTD. |
BRUCE F MACKLER |
| K000669 |
05/26/2000 |
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY |
MEDIVISION ENDOSCOPY |
WAYNE B STERNER |
| K000386 |
05/05/2000 |
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K001153 |
05/03/2000 |
MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM |
MEDTRONIC SURGICAL NAVIGATION |
VICTORIA RENDON |
| K000233 |
05/19/2000 |
MENICON SF-P |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K000133 |
05/19/2000 |
MENICON Z |
MENICON U.S.A., INC. |
BEVERLY D VENUTI |
| K000563 |
05/17/2000 |
MODIFICATION TO ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
KENNETH RAICHMAN |
| K001237 |
05/18/2000 |
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K994380 |
05/02/2000 |
CEDIA DAU AMPHASSURE ASSAY |
MICROGENICS CORP. |
NEAL BELLET |
| K993699 |
05/16/2000 |
THE STRIPPER |
MID-ATLANTIC DIAGNOSTICS, INC. |
TERRANCE J FORTINO |
| K000680 |
05/25/2000 |
VISION ESTHETIC PORCELAIN SYSTEM |
MIDATLANTIC DIVISION OF DENTREX, INC. |
LAURANCE W POWELL |
| K000690 |
05/17/2000 |
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE |
MINNESOTA MINING AND MFG. CO. |
LINDA JOHNSON |
| K000999 |
05/22/2000 |
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
MULTISAFE SDN BHD |
ABD. HADI BIN HUSIN |
| K992178 |
05/12/2000 |
BALLOON FOR ULTRASONIC ENDOSCOPES |
N.M. BEALE CO. INC. |
NATHANIEL M BEALE |
| K000604 |
05/23/2000 |
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT |
NATUROPATHIC LABORATORIES INTERNATIONAL, INC. |
EMALEE G MURPHY |
| K993921 |
05/23/2000 |
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 |
NDD MEDICAL TECHNOLOGIES |
OSCAR KAELIN |
| K993877 |
05/25/2000 |
NELSON WATER SYSTEMS FOR HEMODIALYSIS |
NELSON ENVIRONMENTAL TECHNOLOGIES, INC. |
BURKE A WEST |
| K000812 |
05/17/2000 |
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) |
NEUROSOFT, INC. |
DAVID B JONES |
| K994140 |
05/09/2000 |
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K001085 |
05/01/2000 |
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K993337 |
05/16/2000 |
APOLLO MULTI-RACIAL REFERENCE POPULATION |
NORLAND MEDICAL SYSTEMS, INC. |
TERRY SCHWALENBERG |
| K000710 |
05/11/2000 |
MD 10, SEM, SM 12, CBM |
NOUVAG AG |
MARGIT ESCHBAUMER |
| K001339 |
05/17/2000 |
MRI FASTSYSTEM RETRACTOR SYSTEM |
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. |
CATHERINE MILLER |
| K001169 |
05/16/2000 |
OPTIVU HDVD SYSTEM |
OPTIMIZE, INC. |
KEN GONG |
| K001197 |
05/11/2000 |
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K000399 |
05/15/2000 |
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 |
ORASURE TECHNOLOGIES, INC. |
R. SAM NEIDBALA |
| K000691 |
05/04/2000 |
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS |
ORATEC INTERVENTIONS, INC. |
JENNIFER BRENNAN |
| K001310 |
05/05/2000 |
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K001266 |
05/02/2000 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA |
Ortho-Clinical Diagnostics, Inc. |
DARLENE PHILLIPS |
| K000930 |
05/22/2000 |
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K000928 |
05/15/2000 |
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K994225 |
05/18/2000 |
PALOMAR SLP 2000 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K993586 |
05/22/2000 |
SPORTSIGHT GP |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K000694 |
05/11/2000 |
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) |
PECTOFIX, INC. |
ERIC BANNON |
| K001397 |
05/26/2000 |
QUICKSCREEN PRO DRUG CUP, MODEL 9195X |
PHAMATECH |
CARL MONGIOVI |
| K000819 |
05/12/2000 |
PHILIPS CT SECURA MV |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
FRANK GIANELLI |
| K000514 |
05/10/2000 |
RUMBAR DRAINAGE SYSTEM |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K001055 |
05/11/2000 |
MODEL 4300 PSARRAY EEG ELECTRODE SET |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K000734 |
05/05/2000 |
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 |
PIONEER SURGICAL TECHNOLOGY |
AMY MOMMAERTS |
| K000771 |
05/03/2000 |
DIMAX 2 |
PLANMECA OY |
BOB PIENKOWSKI |
| K001221 |
05/19/2000 |
MALE LATEX COMDOM WITH DOTTED SURFACE |
PLEASURE LATEX PRODUCTS SDN. BHD. |
KOI-YONG LIM |
| K994126 |
05/04/2000 |
MODULAR-PLUS REVISION STEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K000795 |
05/26/2000 |
RIGID GAS PERMEABLE CONTACT LENS |
POLYMER TECHNOLOGY |
DEBRA L.B. KETCHUM |
| K991894 |
05/24/2000 |
BIOSCANNER TRIGLYCERIDES TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K001327 |
05/23/2000 |
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) |
PREMIER PATHWAY SDN. BHD. |
JANNA P TUCKER |
| K001108 |
05/30/2000 |
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDDO MARASIGAN |
| K993131 |
05/22/2000 |
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY |
PRIMUS, INC. |
JIMMIE K NOFFSINGER |
| K001225 |
05/17/2000 |
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K001098 |
05/18/2000 |
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 |
PRO. DUCT HEALTH, INC. |
ANGELA B SOITO |
| K001132 |
05/01/2000 |
BONE BIOPSY NEEDLE |
PROMEX, INC. |
JOSEPH L MARK |
| K000216 |
05/09/2000 |
PSK ENDOSCOPE CLEANING SYSTEM |
PSK CONNECTORS PTY LTD |
BRIAN NEWTON |
| K994426 |
05/23/2000 |
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K991886 |
05/11/2000 |
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR |
PULSION MEDICAL SYSTEMS, INC. |
ULF BORG |
| K994274 |
05/31/2000 |
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) |
QUEST MEDICAL, INC. |
MALCOLM LEWIS |
| K993777 |
05/25/2000 |
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES |
R-GROUP INTL. |
KERRY A KAHN |
| K001431 |
05/17/2000 |
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, INC. |
KEVIN J O'CONNELL |
| K000783 |
05/04/2000 |
DIRECT TIBC CALIBRATOR |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K000781 |
05/02/2000 |
DIRECT TIBC KIT |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K001208 |
05/12/2000 |
ESPIRT |
RESPIRONICS, INC. |
KATHY MOORE |
| K000420 |
05/08/2000 |
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 |
RETINALABS.COM |
FRANK TIGHE |
| K000416 |
05/08/2000 |
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 |
RETINALABS.COM |
FRANK TIGHE |
| K000457 |
05/09/2000 |
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES |
RETINALABS.COM |
FRANK TIGHE |
| K000752 |
05/09/2000 |
RHIGENE MESACUP2 TEST- RNP |
RHIGENE, INC. |
DAVE KOLESAR |
| K000750 |
05/09/2000 |
RHIGENE MESACUP2 TEST- SCL-70 |
RHIGENE, INC. |
DAVE KOLESAR |
| K000755 |
05/09/2000 |
RHIGENE MESACUP2 TEST- SM |
RHIGENE, INC. |
DAVE KOLESAR |
| K000749 |
05/09/2000 |
RHIGENE MESACUP2 TEST- SSA |
RHIGENE, INC. |
DAVE KOLESAR |
| K000751 |
05/09/2000 |
RHIGENE MESACUP2 TEST- SSB |
RHIGENE, INC. |
DAVE KOLESAR |
| K000673 |
05/26/2000 |
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K000905 |
05/12/2000 |
URETHROTOME 8667.XXX AND 8670.XXX |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K000155 |
05/17/2000 |
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K000784 |
05/18/2000 |
THE CARDIAC READER SYSTEM |
ROCHE DIAGNOSTICS CORP. |
SUSAN D GOLDSTEIN-FALK |
| K000723 |
05/19/2000 |
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) |
ROCHESTER MEDICAL CORP. |
MARY WILEN |
| K001119 |
05/19/2000 |
ROVERS ENDOCERVEX-BRUSH |
ROVERS MEDICAL DEVICES B.V. |
TODD M GATES |
| K993528 |
05/31/2000 |
RUSCH EMERGENCY MASK |
RUSCH, INC. |
RONALD YOUNG |
| K001429 |
05/26/2000 |
MODIFICATION TO ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
DANIEL MICHAELI |
| K992823 |
05/12/2000 |
SPIROVIT SP-2, PNEUMOCHECK II |
SCHILLER AG |
MARKUS BUETLER |
| K001140 |
05/03/2000 |
IDS5 IMAGE DISPLAY SYSTEM |
SECTRA AB |
HERMAN OOSTERWIJK |
| K000578 |
05/05/2000 |
SERIM LEUKOCYTE ESTERASE TEST STRIPS |
SERIM RESEARCH CORP. |
ROBERT J CARRICO |
| K993520 |
05/03/2000 |
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
SERV-A-PURE CO. |
RICHARD C HERZBERGER |
| K001128 |
05/23/2000 |
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K001065 |
05/23/2000 |
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR |
SHEEN MORE ENT. CO., LTD. |
KEN HUANG |
| K001155 |
05/23/2000 |
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR |
SHEEN MORE ENT. CO., LTD. |
KEN HUANG |
| K982101 |
05/02/2000 |
SHELHIGH NO-REACT DURA SHIELD |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K991422 |
05/03/2000 |
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K001315 |
05/26/2000 |
MODIFICATION TO KION ANESTHESIA SYSTEM |
SIEMENS ELEMA AB |
DAVE SIMARD |
| K000672 |
05/02/2000 |
HELIODENT VARIO |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
| K994350 |
05/23/2000 |
NEER III TOTAL SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
NEAL DEFIBAUGH |
| K991031 |
05/10/2000 |
COLORADO II SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K000720 |
05/30/2000 |
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
STEVEN J OJALA |
| K001438 |
05/16/2000 |
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
STEVEN J OJALA, PH.D |
| K992819 |
05/11/2000 |
WAND PLUS |
SPINTECH, INC. |
DANIEL J MANELLI |
| K001367 |
05/31/2000 |
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX |
ST. JUDE MEDICAL, INC. |
PAUL CORNELISON |
| K001346 |
05/24/2000 |
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX |
ST. JUDE MEDICAL, INC. |
PAUL CORNELISON |
| K983068 |
05/31/2000 |
RELIANCE FAMILY OF WASHER-DISINFECTORS |
STERIS Corporation |
RAYMOND URSICK |
| K001444 |
05/15/2000 |
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K000493 |
05/15/2000 |
STRYKER IRRIGATION TUBE SET |
Stryker Endoscopy |
MARK KUIPER |
| K000348 |
05/03/2000 |
COLORADO MICRODISSECTION NEEDLE |
STRYKER LEIBINGER |
KRISTYN R KELLEY |
| K000349 |
05/03/2000 |
MOTORIZED MICRO MULTILEAF COLLIMATOR |
STRYKER LEIBINGER |
KRISTYN R KELLEY |
| K000530 |
05/17/2000 |
BELLEGLASS HP ENAMEL |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K000682 |
05/01/2000 |
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K000816 |
05/04/2000 |
SHARP BRAND ACUPUNCTURE NEEDLES |
TCM SUPPLY CORP. |
WILLIAM HUNG LEE |
| K000179 |
05/15/2000 |
NUZONE NITRILE SURGICAL GLOVES POWDER FREE |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K000178 |
05/23/2000 |
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K994329 |
05/26/2000 |
IIVS INTEGRATED IMAGE VIEWING STATION |
TERARECON, INC. |
DAVID W SCHLERF |
| K000665 |
05/02/2000 |
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
TFX MEDICAL, INC. |
KARENANN J BROZOWSKI |
| K991803 |
05/05/2000 |
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991802 |
05/05/2000 |
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991801 |
05/05/2000 |
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991804 |
05/05/2000 |
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K001241 |
05/09/2000 |
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K001203 |
05/26/2000 |
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K000140 |
05/03/2000 |
CLINI-DENT |
THE PRECIDENT GROUP |
WENDY BEDALE |
| K000577 |
05/05/2000 |
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA |
THE YOSHIDA DENTAL MFG. CO., LTD. |
KIYOSHI YOSHIDA |
| K992192 |
05/12/2000 |
AIRPILOTMASK, MODEL TMS-900 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
| K000745 |
05/03/2000 |
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
TILLOTSON HEALTHCARE CORP. |
THOMAS N TILLOTSON |
| K000849 |
05/19/2000 |
SOFTFORM FACIAL IMPLANT |
TISSUE TECHNOLOGIES, INC. |
JESSE KRAMER |
| K990331 |
05/31/2000 |
SURGEN VALVE |
TIVA MEDICAL |
JIM CAPUTO |
| K001035 |
05/23/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K000333 |
05/03/2000 |
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD |
TRIAD SURGICAL TECHNOLOGIES, INC. |
BRIAN MCGAVIN |
| K000189 |
05/11/2000 |
PQ1 |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K000993 |
05/26/2000 |
LIBERTY 9000 BREAST COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K000974 |
05/23/2000 |
FOWLER ENDOCURETTE, MODEL CUR-XXX |
UTAH MEDICAL PRODUCTS, INC. |
KEVIN L CORNWELL |
| K000922 |
05/24/2000 |
PROTON VISION |
VARIAN ASSOC., INC. |
LINDA S NASH |
| K000597 |
05/17/2000 |
VITA RESPONSE |
VIDENT |
BARBARA J LEWANDOWSKI |
| K000327 |
05/02/2000 |
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 |
VISX, INCORPORATED |
DAVID M PATINO |
| K000623 |
05/16/2000 |
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY Y YINGLING |
| K000625 |
05/23/2000 |
SCANDINAVIAN IVF SCIENCES AB, G1.2 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY Y YINGLING |
| K000626 |
05/23/2000 |
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY L YINGLING |
| K000621 |
05/16/2000 |
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY L YINGLING |
| K000618 |
05/17/2000 |
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY L YINGLING |
| K991348 |
05/17/2000 |
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 |
VITROLIFE SWEDEN AB |
EILER ANDERSON |
| K001002 |
05/24/2000 |
WAKO LIPASE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K001238 |
05/03/2000 |
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K000719 |
05/30/2000 |
NEOCARE 20 MICRON BLOOD FILTER |
WHATMAN, INC. |
RANDALL D BATH |
| K001041 |
05/23/2000 |
AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K001280 |
05/15/2000 |
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K000880 |
05/22/2000 |
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K000879 |
05/22/2000 |
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
