| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K980732 |
05/15/1998 |
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT |
3M HEALTH CARE |
DIANA THORSON |
| K974038 |
05/11/1998 |
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K980345 |
05/27/1998 |
ETEST CEFTRIAXONE |
AB BIODISK |
ANNE BOLMSTROM |
| K980342 |
05/29/1998 |
ETEST CHLORAMPHENICAL |
AB BIODISK |
ANNE BOLMSTROM |
| K980773 |
05/18/1998 |
ETEST GREPAFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K980338 |
05/28/1998 |
ETEST OFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K980347 |
05/27/1998 |
ETEST TETRACYCLINE |
AB BIODISK |
ANNE BOLMSTROM |
| K981134 |
05/28/1998 |
ETEST TETRACYCLINE |
AB BIODISK |
ANNE BOLMSTROM |
| K980603 |
05/13/1998 |
ETEST TROVAFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K980348 |
05/29/1998 |
ETEST VANCOMYCIN |
AB BIODISK |
ANNE BOLMSTROM |
| K981468 |
05/27/1998 |
ALBG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981245 |
05/20/1998 |
ALKALINE PHOSPHATASE (ALKP) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981218 |
05/01/1998 |
CREATINE KINASE (CK) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981240 |
05/29/1998 |
CREATININE (CREA) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981185 |
05/07/1998 |
GLU |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981241 |
05/01/1998 |
IRON |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981338 |
05/18/1998 |
LD-1 |
ABBOTT LABORATORIES |
MIKE LITTLEFIELD |
| K981192 |
05/01/1998 |
MG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981336 |
05/01/1998 |
TBIL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981279 |
05/20/1998 |
TIBC |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981189 |
05/07/1998 |
URIC ACID |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981457 |
05/27/1998 |
ALBP |
ABBOTT MFG., INC. |
MARK LITTLEFIELD |
| K981232 |
05/18/1998 |
CA |
ABBOTT MFG., INC. |
MARK LITTLEFIELD |
| K981231 |
05/12/1998 |
CO2 |
ABBOTT MFG., INC. |
MARK LITLEFIELD |
| K981113 |
05/29/1998 |
PEDIATRIC PRC |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
| K980715 |
05/06/1998 |
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K974649 |
05/01/1998 |
BIO-POST DENTAL POST SYSTEM |
ADVANCED AEROMEDICAL, INC. |
CAROLANN KOTULA |
| K980021 |
05/11/1998 |
EXTENTRAC |
ADVANCED BACK TECHNOLOGIES |
DAVID F CUCCIA |
| K980844 |
05/11/1998 |
SURGIDEV SILICONE PUNCTUM PLUG |
ADVANCED VISION SCIENCE |
KHALID MENTAK |
| K980703 |
05/04/1998 |
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K980704 |
05/11/1998 |
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K974596 |
05/26/1998 |
DIMERTEST LATEX ASSAY |
AGEN BIOMEDICAL LTD. |
RUSSELL RICHARDS |
| K980292 |
05/19/1998 |
CATARACT LIQUEFRACTURE DEVICE |
ALCON LABORATORIES |
MARTIN A KAUFMAN |
| K980892 |
05/11/1998 |
HAKOMED ELECDT / PRO ELEDT SERIES |
ALIVE, INC. |
KAI HANSJURGENS |
| K980958 |
05/11/1998 |
HAKOMED ELECDT/VACUPULLS |
ALIVE, INC. |
KAI HANSJURGENS |
| K981116 |
05/19/1998 |
SOVEREIGN CATARACT EXTRACTION SYSTEM |
ALLERGAN, INC. |
MARCIA S YAROSS, PH,D. |
| K980788 |
05/22/1998 |
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM |
ALPHATEC MFG., INC. |
DAN PASTRICK |
| K981392 |
05/11/1998 |
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE |
ANSELL PERRY |
JAMES R CHATTERTON |
| K980880 |
05/20/1998 |
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K974488 |
05/26/1998 |
AIRPREP SYSTEM - MODEL 9001 |
ASI MEDICAL, INC. |
JOHN W MCPEEK |
| K981423 |
05/20/1998 |
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 |
AUTOGENESIS, INC. |
JAMES EDWARDS |
| K972595 |
05/20/1998 |
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K980988 |
05/11/1998 |
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K980407 |
05/27/1998 |
HOPE NEBULIZER |
B & B MEDICAL TECHNOLOGIES, INC. |
STEPHEN W BRIGGS III |
| K974196 |
05/12/1998 |
MEGAVAC SYSTEM |
BARRY J. KAPLAN, INC. |
BARRY J KAPLAN |
| K980658 |
05/19/1998 |
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K980656 |
05/19/1998 |
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILSINSON |
| K974571 |
05/21/1998 |
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE |
BAXTER HEALTHCARE CORP. |
MARY ELLEN S NYDER |
| K974678 |
05/29/1998 |
B-D AUTO-INJECTOR |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MICHAEL GROSS |
| K974883 |
05/01/1998 |
BACTEC MGIT 960 SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
JODY J HOFFMANN |
| K981354 |
05/01/1998 |
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 |
BECKMAN INSTRUMENTS, INC. |
ELLEN M VOSS |
| K981403 |
05/08/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K971994 |
05/01/1998 |
B-D ASSURE EAR THERMOMETER |
BECTON DICKINSON CONSUMER PRODUCTS |
PETER ZURLO |
| K980858 |
05/22/1998 |
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
| K980683 |
05/01/1998 |
TROVAFLOXACIN 10G, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
| K981532 |
05/12/1998 |
LYPHOCHEK IMMUNOASSAY PLUS CONTROL |
BIO-RAD |
ELIZABETH PLATT |
| K981070 |
05/20/1998 |
20-HOLE ADAPTATION PLATE |
BIOMET, INC. |
MARY VERSTYNEN |
| K980428 |
05/05/1998 |
BIOMET BIAXIAL TOTAL ELBOW |
BIOMET, INC. |
DEBORAH M MATARAZZO R.N., B.S.N. |
| K980665 |
05/20/1998 |
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS |
BIOMET, INC. |
PATRICIA S BERES |
| K973922 |
05/12/1998 |
ARCHIMED 4210 AND 4220 |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K973646 |
05/07/1998 |
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER |
BIRD PRODUCTS CORP. |
NEIL BATTISTE |
| K974491 |
05/13/1998 |
ACCU-CHEK A1C HEMOGLOBIN TEST |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K980731 |
05/22/1998 |
ACCU-CHEK COMFORT CURVE TEST STRIPS |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K981401 |
05/18/1998 |
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K980746 |
05/26/1998 |
CEDIA DAU EDDP ASSAY |
BOEHRINGER MANNHEIM CORP. |
JULIE SMITH |
| K981413 |
05/13/1998 |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
BOSTON SCIENTIFIC SCIMED, INC. |
MARIA BRITTLE |
| K980548 |
05/13/1998 |
DURA-PATCH MODEL DP-XXX |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
| K980046 |
05/01/1998 |
BRONCHIAL CATHETER SYSTEM |
BRONCUS TECHNOLOGIES, INC. |
GLENDON E FRENCH |
| K971421 |
05/14/1998 |
BARD ISOFLOW BLOOD PUMP |
C.R. BARD, INC. |
SANDRA L PERREAND |
| K980575 |
05/15/1998 |
SITESEER ANGIOGRAPHIC CATHETER |
C.R. BARD, INC. |
VICKI BRUNELLE |
| K980065 |
05/11/1998 |
C/T MED-SYSTEMS CASSETTE SYSTEM |
C/T MED SYSTEM, LTD. |
ALAN BOOKER |
| K980246 |
05/06/1998 |
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM |
CANON U.S.A., INC. |
GLENN IMPAL |
| K981206 |
05/26/1998 |
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) |
CARDIOVASCULAR DIAGNOSTICS, INC. |
GREG GODLEVSKI |
| K981037 |
05/22/1998 |
CLEAR (TM) SPECIAL NIT COMB |
CARE TECHNOLOGIES, INC. |
DANIEL J MANELLI |
| K972020 |
05/05/1998 |
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K981368 |
05/01/1998 |
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K981382 |
05/01/1998 |
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K980965 |
05/01/1998 |
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL |
CAVEX HOLLAND B.V. |
BERNARD VAN DUJIN |
| K973820 |
05/12/1998 |
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE |
CIRCON CORP. |
ANDREW D SIMONS |
| K980598 |
05/01/1998 |
EBNA-1 IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
WILLIAM L BOTELER, JR. |
| K980431 |
05/28/1998 |
SURGISIS |
COOK BIOTECH, INC. |
NEAL E FEARNOTM PH.D |
| K980649 |
05/13/1998 |
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K974560 |
05/11/1998 |
CORDIS VANGUARD STEERABLE GUIDEWIRES |
CORDIS CORP. |
DENNIS GRIFFIN |
| K981407 |
05/20/1998 |
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER |
CORDIS CORP. |
MIRJAM BARBOZA |
| K980961 |
05/28/1998 |
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. |
CORDIS WEBSTER, INC. |
MARY ADAMS |
| K970726 |
05/18/1998 |
VAPOCIDE |
COTTRELL, LTD. |
MARY MC NAMARA-CULLINANE |
| DEN980001 |
05/29/1998 |
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND |
CRANIAL TECHNOLOGIES, INC. |
TIMOTHY R LITTLEFIELD |
| K981276 |
05/01/1998 |
N-ASSAY L D-BIL |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
| K980754 |
05/18/1998 |
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G |
CROCKER INDUSTRIAL RESOURCES SDN. BHD. |
CHONG LEE CHUAN |
| K972849 |
05/28/1998 |
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K981099 |
05/26/1998 |
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
| K973840 |
05/21/1998 |
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER |
DAIG CORP. |
DEAN BRUHN-DING, RAC |
| K980385 |
05/01/1998 |
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES |
DATASCOPE CORP. |
WHITNEY TORNING |
| K980780 |
05/29/1998 |
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES |
DATASCOPE CORP. |
WHITNEY TORNING |
| K980384 |
05/01/1998 |
TRIP TONOMETRY CATHETER, 18F |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
| K974015 |
05/18/1998 |
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL |
DAVIS & GECK, INC. |
STEPHEN J TAMSETT |
| K980610 |
05/18/1998 |
DEXON RAPID (DEXON R) |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K980620 |
05/15/1998 |
DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM |
DENTATUS USA, LTD. |
STEPHEN B RUBINSKY |
| K974245 |
05/22/1998 |
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K980595 |
05/11/1998 |
DEPUY ORTHOTECH CATERA SUTURE ANCHOR |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K980794 |
05/20/1998 |
DUAL LOCK HIP STEM |
DEPUY, INC. |
ARLENE C SAULL, RAC |
| K981239 |
05/14/1998 |
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
DEROYAL SURGICAL |
CAMILLE MATLOCK |
| K981059 |
05/12/1998 |
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK, R.T.B.SC |
| K980206 |
05/01/1998 |
IMMULITE ANTI-TG AB |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE, PH.D. |
| K980833 |
05/01/1998 |
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K981455 |
05/13/1998 |
THIRD GENERATION PSA CONTROL MODULE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K981607 |
05/27/1998 |
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K981270 |
05/01/1998 |
IRMA BLOOD ANALYSIS SYSTEM |
DIAMETRICS MEDICAL, INC. |
STEVE BOEH |
| K980886 |
05/29/1998 |
BABYTHERM 8000 LDR |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K981472 |
05/07/1998 |
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
DRAEGER MEDICAL, INC. |
J. TERESA DORRIETY |
| K980861 |
05/20/1998 |
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SHARMINI ATHERAY |
| K980863 |
05/11/1998 |
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SHARMINI ATHERAY |
| K980777 |
05/04/1998 |
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SHARMINI ATHERAY, M.SC |
| K980636 |
05/20/1998 |
FIBER OPTIC ENDOILLUMINATION PROBE |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K981267 |
05/06/1998 |
FACTS MONOBLOCK |
DYNARAD CORP. |
RAYMOND MANEZ |
| K980308 |
05/06/1998 |
ECHOTECH 3D FREESCAN |
ECHOTECH 3D IMAGING SYSTEMS GMBH |
KEVIN MORNINGSTAR |
| K971831 |
05/07/1998 |
QUICK CHECK INSTANT THERMOMETER |
EJB MEDICAL, INC. |
EDWARD J BUZBY |
| K974536 |
05/20/1998 |
PHOTODERM HR SYSTEM |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K980815 |
05/01/1998 |
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
| K981000 |
05/15/1998 |
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN |
EUROPEAN DENTAL IMPORTS, INC. |
MICHAEL H EVERNGAM |
| K980661 |
05/01/1998 |
CERA E DENTAL ALLOY |
EUROPEAN DENTAL IMPORTS, INC. |
GISELA N EVERNGAM |
| K981001 |
05/18/1998 |
ORION VESTA DENTAL ALLOY |
EUROPEAN DENTAL IMPORTS, INC. |
MICHAEL H EVERNGAM |
| K981002 |
05/18/1998 |
ORION WX DENTAL ALLOY |
EUROPEAN DENTAL IMPORTS, INC. |
MICHAEL H EVERNGAM |
| K963658 |
05/05/1998 |
EXEL AVF SINGLE NEEDLE |
EXEL INTL. |
ARMAND HAMID |
| K981183 |
05/07/1998 |
CARESIDE GLUCOSE |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K981045 |
05/20/1998 |
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K974008 |
05/13/1998 |
PFLEIDERER'S INTRATYMPANIC CATHETER |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K980647 |
05/15/1998 |
EYE IRRIGATOR MODEL #2020 |
EYE-DEAL OCULAR SAFETY PRODUCTS, INC. |
ELAINE DUNCAN |
| K980963 |
05/11/1998 |
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) |
FOREMOST DENTAL MFG., INC. |
AN-SHIH CHENG |
| K980917 |
05/27/1998 |
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR |
FORTUNE MEDICAL INSTRUMENT CORP. |
KAREN U SALINAS |
| K974584 |
05/14/1998 |
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
FRESENIUS USA, INC. |
VIRGINIA SINGER |
| K973924 |
05/07/1998 |
FRIOS BONESHIELD |
FRIATEC AG |
ROBERT J SLOMOFF |
| K981404 |
05/20/1998 |
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
| K980808 |
05/08/1998 |
ENDO FMS UROLOGY |
FUTURE MEDICAL SYSTEMS, INC. |
PATRICK JANIN |
| K980479 |
05/06/1998 |
QUICK-CUT AUTOMATIC BIOPSY SYSTEM |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K980676 |
05/21/1998 |
SPIGAL NEEDLE |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K981085 |
05/18/1998 |
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM |
GAMBRO HEALTHCARE |
WILLIAM M TOWNSEND |
| K981296 |
05/29/1998 |
GEEN MEDISOX |
GEEN HEALTHCARE, INC. |
GREG W GEEN |
| K980210 |
05/15/1998 |
VARIOUS SURGICAL OR PATIENT DRAPES |
GEL-LITE, L.L.C. |
Ed Horton |
| K974533 |
05/07/1998 |
TRIMPORT |
GERARD MEDICAL, INC. |
RICHARD CAYER |
| K980857 |
05/12/1998 |
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE |
GRAPHIC CONTROLS CORP. |
KATHLEEN SELOVER |
| K970968 |
05/21/1998 |
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
DAVID W SCHLERF |
| K980393 |
05/01/1998 |
SOPRANO CRYO-THERAPY SYSTEM |
GYNECARE INNOVATION CENTER |
JEAN LADOUCEUR |
| K980640 |
05/01/1998 |
HEELBO WAIST AND CHEST VEST |
HEELBO, INC. |
JOSEPH S TOKARZ |
| K980671 |
05/12/1998 |
COLOSCREEN-ES |
HELENA LABORATORIES |
PAT FRANKS |
| K980650 |
05/01/1998 |
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL |
HELENA LABORATORIES |
PAT FRANKS |
| K980337 |
05/12/1998 |
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM |
HELIX DIAGNOSTICS, INC. |
VIRGINIA L CAPPEL |
| K973955 |
05/11/1998 |
HERNIAMESH SURGICAL MESHES |
HERNIAMESH |
LORENA A TRABUCCO |
| K980687 |
05/22/1998 |
SONOS 5500 ULTRASOUND IMAGING SYSTEM |
HEWLETT-PACKARD CO. |
PAUL SCHRADER |
| K980691 |
05/11/1998 |
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K980985 |
05/01/1998 |
SCMD-1000 |
HOWARD INSTRUMENTS, INC. |
JACK W HOWARD |
| K980713 |
05/22/1998 |
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K981201 |
05/29/1998 |
OSTEOLOCK ACETABULAR CUP |
HOWMEDICA CORP. |
FRANK MAAS |
| K980558 |
05/28/1998 |
PAINBUSTER INFUSION SYSTEM |
I-FLOW CORP. |
ROBERT J BARD, ESQ., R.A.C. |
| K980684 |
05/06/1998 |
VR NETSERVE |
I.S.G. TECHNOLOGIES, INC. |
CAROL NAKAGAWA |
| K981327 |
05/11/1998 |
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
DONNA WARD |
| K971408 |
05/12/1998 |
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) |
IKONOS CORP. |
CHARLES ALBERT |
| K980096 |
05/01/1998 |
OAC (OPTICAL ASPIRATING CURETTE) |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
RONALD H BERGESON |
| K980781 |
05/22/1998 |
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS |
IMPLEX CORP. |
ROBERT POGGIE, PH.D. |
| K981076 |
05/07/1998 |
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K981079 |
05/07/1998 |
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K980673 |
05/21/1998 |
SPYROSORB FOAM ISLAND WOUND DRESSING |
INNOVATIVE TECHNOLOGIES (US), INC. |
JULIE CHAFFEE |
| K980989 |
05/27/1998 |
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
ANNA E MCRIGHT |
| K974456 |
05/01/1998 |
CMVGEN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K974711 |
05/01/1998 |
COAMATIC PLASMINOGEN |
INSTRUMENTATION LABORATORY CO. |
CAROLE MARBLE |
| K980646 |
05/06/1998 |
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K981200 |
05/26/1998 |
IL TEST PLASMINOGEN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K980986 |
05/11/1998 |
PROCAD |
IVOCLAR USA, INC. |
PETER P MANCUSO |
| K980456 |
05/05/1998 |
JOBST ATHROMBIC PUMP SYSTEM 2600 |
JOBST A BEIERSDORF CO. |
KENNETH M BOLAM |
| K974080 |
05/18/1998 |
CRITIKON SOFT BLOOD PRESSURE CUFF |
JOHNSON & JOHNSON MEDICAL, INC. |
DARLENE T KORAB |
| K980801 |
05/29/1998 |
J-FX BIPOLAR HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
MARY E GRAY |
| K980852 |
05/01/1998 |
GII SPINAL FIXATION SYSTEM |
KAREN E. WARDEN, M.E.B.E. |
KAREN E WARDEN |
| K981458 |
05/20/1998 |
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
| K980694 |
05/08/1998 |
KSEA PLASTIC TROCARS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K980563 |
05/20/1998 |
SKAR-KARE SHEET |
LIFE MEDICAL SCIENCES, INC. |
JULES T MITCHEL |
| K980942 |
05/11/1998 |
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE |
LONDON INTERNATIONAL GROUP, INC. |
NEIL ANDERSON |
| K980319 |
05/20/1998 |
DUREX ULTRA COMFORT |
LONDON INTL. LLC. |
NEIL ANDERSON, RAC |
| K981179 |
05/15/1998 |
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES |
LOVYTEX SDN BHD |
M.G. DESAI |
| K980685 |
05/20/1998 |
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS |
LUMENIS, INC. |
ANNE WORDEN |
| K980809 |
05/11/1998 |
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER |
LUMISYS, INC. |
GARY J ALLSENBROOK |
| K980763 |
05/28/1998 |
LYSONIX LIPOPLASTY ACCESS PORT |
LYSONIX, INC. |
RONALD F LAGERQUIST |
| K973615 |
05/20/1998 |
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES |
MACRO RUBBER INDUSTRIAL, INC. |
ED RANSOM |
| K980495 |
05/07/1998 |
MUSE CARDIOVASCULAR INFORMATION SYSTEM |
MARQUETTE MEDICAL SYSTEMS, INC. |
KRISTIN PABST |
| K981061 |
05/26/1998 |
INTRAVASCULAR RETRIEVAL DEVICE |
MED INSTITUTE, INC. |
NEAL FEARNOT |
| K981073 |
05/15/1998 |
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK |
MEDCOM LAUNDRY SERVICE, INC. |
GARY VANDRIEL |
| K973561 |
05/11/1998 |
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K980193 |
05/27/1998 |
MANAN GENERAL UTILITY DRAINAGE CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K980192 |
05/27/1998 |
MANAN NEPHROSTOMY DRAINAGE CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K981510 |
05/08/1998 |
SONOACE 6000/ ULTRAMARK 400 |
MEDISON AMERICA, INC. |
|
| K971077 |
05/15/1998 |
COVERTIP SAFETY SYRINGE |
MEDISYS TECHNOLOGIES, INC. |
JOEL S FADEN |
| K980417 |
05/04/1998 |
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V |
MEDRAD, INC. |
SANDRA PAVLOVIC |
| K973360 |
05/26/1998 |
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD |
MEDTRONIC VASCULAR |
SUSAN NODDIN |
| K980076 |
05/12/1998 |
PREMIER PLATINUM HPSA |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K974882 |
05/22/1998 |
DOWNSCAN LT |
MERLIN ENGINEERING WORKS, INC. |
GERALD ENGBRETSON |
| K980609 |
05/18/1998 |
SEGMENTAL DEFECT REPLACEMENT SYSTEM |
METAGEN, L.L.C. |
FLOYD G LARSON |
| K981373 |
05/27/1998 |
ALKPHASE-B ASSAY KIT |
METRA BIOSYSTEMS, INC. |
JILL VISOR |
| K981388 |
05/29/1998 |
MICRO-STRIP FOR COCAINE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K981389 |
05/29/1998 |
DISPOSABLE RE-NEW FORCEPS |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
| K981188 |
05/20/1998 |
ELECTROSURGICAL CAUTERY PROBES |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
| K980510 |
05/01/1998 |
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) |
MICROSPECIALTIES, INC. |
CHARLES VASSALLO |
| K980508 |
05/01/1998 |
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 |
MICROSPECIALTIES, INC. |
CHARLES VASSALLO |
| K981460 |
05/20/1998 |
CUB DIS II DPOAE MEASUREMENT SYSTEM |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
| K980859 |
05/12/1998 |
HEMOCOR HPH MINI HEMOCONCENTRATOR |
MINNTECH CORP. |
MARK MURPHY |
| K980295 |
05/19/1998 |
OPHTHAVISION IMAGING SYSTEM |
MRP GROUP, INC. |
MATTHEW CARNEVALE |
| K963364 |
05/01/1998 |
GLASS VAN GLASS SYRINGES |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
| K981250 |
05/28/1998 |
LICEMEISTER COMB |
NATIONAL PEDICULOSIS ASSOC. |
HANS SCHWARTZ |
| K973929 |
05/21/1998 |
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM |
NEOTONUS, INC. |
JAMES R VEALE |
| K980866 |
05/20/1998 |
MEDI-DX 7000 CPT WITH AMREX ELECTRODES |
NEURO-DIAGNOSTIC ASSOC. |
JAMES L HEDGECOCK, DC, PHD |
| K980018 |
05/19/1998 |
CRISTOBAL |
NEWAVE MEDICAL, INC. |
JEAN-LUC BOULNOIS |
| K980547 |
05/13/1998 |
NIDEK PRIMA MODEL GYC-1500/2000 |
NIDEK, INC. |
KEN KATO |
| K974123 |
05/26/1998 |
BRANEMARK SYSTEM DEC 600 DRILLING UNIT |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
| K980460 |
05/05/1998 |
ONPLANT ORTHODONTIC SYSTEM |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
| K973789 |
05/18/1998 |
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC |
NORIAN CORP. |
SUSANNE T SMITH |
| K980125 |
05/20/1998 |
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER |
NORLAND CORP. |
TERRY SCHWALANBERG |
| K981427 |
05/12/1998 |
STAT PROFILE M ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K981425 |
05/12/1998 |
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K981426 |
05/12/1998 |
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K980629 |
05/06/1998 |
VSS, VIRTUAL SIMULATION SYSTEM |
NUCLETRON CORP. |
RALPH E SHUPING |
| K981305 |
05/07/1998 |
OLYMPUS SERUM PROTEIN MULTICALIBRATOR |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K980842 |
05/20/1998 |
COPPER TONGUE SCRAPER |
ONTEL PRODUCTS CORP. |
MIKE K LAKHIANI |
| K980739 |
05/26/1998 |
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K974534 |
05/18/1998 |
MICRO-PLATE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
R S NIEDBALA |
| K974234 |
05/14/1998 |
MICRO-PLATE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
SAM R NIEDBALA |
| K981341 |
05/22/1998 |
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) |
ORASURE TECHNOLOGIES, INC. |
R S NIEDBALA |
| K981700 |
05/29/1998 |
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM |
ORIGIN MEDSYSTEMS, INC. |
CYNTHIA G ROYSTER |
| K980981 |
05/20/1998 |
OMEGA HA COATED TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K981259 |
05/11/1998 |
OSTEO 4.0MM CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTTON |
| K980766 |
05/27/1998 |
OSTEONICS ANTEVERTED NECK HA HIP STEMS |
OSTEONICS CORP. |
DONNA S WILSON |
| K980594 |
05/05/1998 |
OSTEONICS FX-CABLELOK GRIP COMPONENTS |
OSTEONICS CORP. |
DONNA S WILSON |
| K981452 |
05/20/1998 |
OSTEONICS LONG ARM CONTAINMENT RING |
OSTEONICS CORP. |
KATE SUTTON |
| K980502 |
05/05/1998 |
OSTEONICS TOTAL ELBOW SYSTEM |
OSTEONICS CORP. |
KATE SUTTON |
| K980420 |
05/04/1998 |
LIGHTSHEER |
PALOMAR MEDICAL PRODUCTS, INC. |
STEVEN ARMSTRONG |
| K980955 |
05/18/1998 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K980530 |
05/12/1998 |
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K980797 |
05/19/1998 |
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K974285 |
05/28/1998 |
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT |
PERIMED, INC. |
KJELL BAKKEN |
| K973658 |
05/06/1998 |
DIFFUSION PACKAGE / GYROSCAN NT |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K980645 |
05/11/1998 |
PHILIPS GYROSCAN NT RELEASE 6 SERIES |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K974513 |
05/20/1998 |
PINPOINT |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K974830 |
05/20/1998 |
ULTRA BILI LIGHT |
PHYSICIAN ENGINEERED PRODUCTS, INC. |
ROBERT J ROSE |
| K980690 |
05/22/1998 |
CABLE SCREW WITH INTEGRAL CRIMP |
PIONEER SURGICAL TECHNOLOGY |
BURNS O SEVERSON |
| K980741 |
05/11/1998 |
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) |
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
DEBRA L.B. KETCHUM |
| K980811 |
05/12/1998 |
SERAQUEST ANTI-SM/RNP |
QUEST INTL., INC. |
ROBERT A CORT |
| K980810 |
05/12/1998 |
SERAQUEST ANTI-SSA |
QUEST INTL., INC. |
ROBERT A CORT |
| K980584 |
05/18/1998 |
ATLASPLAN |
RADIONICS, INC. |
NICHOLE RIEK |
| K973920 |
05/14/1998 |
STARDUST |
RESPIRONICS, INC. |
RAJI S KASBEKAR |
| K980401 |
05/21/1998 |
FLEXIBLE FIBERSCOPES AND ACCESSORIES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K981584 |
05/28/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K981585 |
05/28/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K974695 |
05/21/1998 |
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K981282 |
05/01/1998 |
ELECSYS AFP |
ROCHE DIAGNOSTICS GMBH |
Patricia M Klimley |
| K980792 |
05/15/1998 |
CU-100A LIGHT CURE UNIT |
ROLENCE ENTERPRISE CO. LTD. |
STERLING CHENG |
| K980793 |
05/15/1998 |
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT |
ROLENCE ENTERPRISE CO. LTD. |
STERLING CHENG |
| K981169 |
05/19/1998 |
RONDEX CPR ISO-SHIELD |
RONDEX PRODUCTS, INC. |
GENE R BALDWIN |
| K973892 |
05/18/1998 |
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) |
RUSCH INTL. |
JAMES R WHITNEY |
| K974141 |
05/21/1998 |
PLUS REUSABLE RESUSCITATOR |
SCHIFF & CO. |
ANNE M CESARIO |
| K980710 |
05/22/1998 |
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
| K974540 |
05/20/1998 |
SIS HERNIA REPAIR DEVICE |
SENTRON MEDICAL, INC. |
ROBERT J MORFF |
| K980837 |
05/20/1998 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K980625 |
05/19/1998 |
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAQUELINE E EMERY |
| K981626 |
05/27/1998 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K981512 |
05/28/1998 |
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 |
SKD, INC. A BECKMAN COULTER CO. |
KAREN RICHARDS |
| K981349 |
05/18/1998 |
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K981347 |
05/18/1998 |
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K981348 |
05/18/1998 |
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K973747 |
05/07/1998 |
CONTROLLED TEMPERATURE CABINET SYSTEM |
SMITH |
DURWARD FARIES, JR. |
| K981156 |
05/20/1998 |
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K980841 |
05/20/1998 |
RCI FIXATION SCREWS |
SMITH & NEPHEW, INC. |
DEMETRIOS TSAKONAS |
| K980604 |
05/19/1998 |
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K980577 |
05/08/1998 |
PRINCESS SYRINGE |
SODEXCO |
GAYLEN COX |
| K981043 |
05/26/1998 |
DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL |
SOLUTION TECHNOLOGIES |
WILLIAM J GRISWOLD, JR |
| K981505 |
05/08/1998 |
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSITE,INC. |
|
| K972502 |
05/28/1998 |
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 |
SPACELABS MEDICAL, INC. |
RUSS GARRISON |
| K980633 |
05/01/1998 |
ENDOSOLV E |
SPECIALITES SEPTODONT |
PETER S REICHERTZ |
| K981474 |
05/07/1998 |
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) |
SPECTRAL DIAGNOSTICS, INC. |
JOSEPH LAURINO |
| K980462 |
05/06/1998 |
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980446 |
05/06/1998 |
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980444 |
05/06/1998 |
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980445 |
05/06/1998 |
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980463 |
05/06/1998 |
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980379 |
05/18/1998 |
PROWESS PRO-SIM |
SSGI PROWESS SYSTEMS |
THOMAS A BOONE |
| K980014 |
05/15/1998 |
THE SYSTEM 2S STEAM STERILIZER |
STERIS Corporation |
RAYMOND URSICK |
| K981516 |
05/11/1998 |
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB |
STERNGOLD/IMPLAMED |
KAREN HICKEY |
| K974771 |
05/29/1998 |
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL |
Stryker Endoscopy |
SALMAAN HAMEED |
| K981211 |
05/22/1998 |
APR -T REVISION HIP STEM |
SULZER ORTHOPEDICS, INC. |
SHAVAWN E PARDUHN |
| K980750 |
05/20/1998 |
RADIOCAMERAS PATIENT POSITIONING SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K980480 |
05/04/1998 |
SYNTEC VITMAN |
SYNTEC, INC. |
JAMES TAYLOR |
| K981372 |
05/11/1998 |
SYNTHES 3.0 MM PC-FIX SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K980928 |
05/11/1998 |
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM |
SYNTHES SPINE |
BARRY E SANDS |
| K981292 |
05/26/1998 |
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
| K981019 |
05/07/1998 |
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
| K980354 |
05/18/1998 |
CRYPTOSPORIDIUM TEST |
TECHLAB, INC. |
DAVID M LYERLY, PH.D. |
| K980935 |
05/14/1998 |
CAPIOX SX HARDSHELL RESERVOIR |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K972114 |
05/18/1998 |
OLYMPUS SONOSURG SYSTEM |
THE OLYMPUS OPTICAL CO. |
SUSAN D GOLDSTEIN-FALK |
| K971207 |
05/13/1998 |
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER |
THERMOLASE CORP. |
ROBERT VAN OSDEL |
| K981008 |
05/27/1998 |
SIMAL CERVICAL STABILIZATION SYSTEM |
TOP SURGICAL PRODUCTS GMBH |
KARENANN J BROZOWSKI |
| K981012 |
05/28/1998 |
AIA-PACK MYOGLOBIN ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K980827 |
05/04/1998 |
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING |
TUCKER & ASSOCIATES |
JANNA P TUCKER |
| K980726 |
05/12/1998 |
ULTRA-BLASTER |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K981128 |
05/11/1998 |
SOFSILK SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JAMIE YIEH |
| K980862 |
05/20/1998 |
TITANIUM SPINAL ROD SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K980624 |
05/11/1998 |
CARDIOSTATION |
UNIVERSAL MEDICAL, INC. |
DOUGLAS M LURIO |
| K980717 |
05/22/1998 |
UROMED SLING KIT |
UROMED CORP. |
NANCY MACDONALD |
| K981491 |
05/29/1998 |
UROSURGE FILASTENT URETERAL STENT |
UROSURGE, INC. |
THOMAS BECZE |
| K981489 |
05/29/1998 |
UROSURGE SPIRASTENT PLUS URETERAL STENT |
UROSURGE, INC. |
THOMAS BECZE |
| K973545 |
05/26/1998 |
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER |
VACUMED, DIV. OF VACUMETRICS, INC. |
RAE NADINE SMITH |
| K973544 |
05/26/1998 |
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER |
VACUMED, DIV. OF VACUMETRICS, INC. |
JACQUILINE E FRAILEY |
| K980994 |
05/29/1998 |
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES |
VENETEC INTL., INC. |
ANITA PELLETIER |
| K980992 |
05/28/1998 |
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES |
VENETEC INTL., INC. |
GRACE HOLLAND |
| K980567 |
05/06/1998 |
CHARGER (ED) |
WALLING MEDICAL EQUIPMENT CO. |
ALLAN WALLING |
| K980752 |
05/06/1998 |
XTEND |
WALLING MEDICAL EQUIPMENT CO. |
ALLAN WALLING |
| K980512 |
05/11/1998 |
LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K971374 |
05/13/1998 |
GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GARY J SFEIR |
| K981256 |
05/12/1998 |
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K981020 |
05/18/1998 |
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K981091 |
05/21/1998 |
NEOCOLLOID, ORTHOPRINT |
ZHERMACK S.P.A. |
EVAN DICK |
