| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K973926 |
10/15/1997 |
O BUTMENT HS IMPLANT |
"O" CO., INC. |
DAVID D DALISE |
| K973899 |
10/14/1997 |
UNIFINE PENTIPS |
*OWNE MUMFORD USA, INC.** |
ROBERT E SHAW |
| K973961 |
10/16/1997 |
3M DENT SYSTEM II PLUS |
3M COMPANY |
LAEL J PICKETT |
| K974032 |
10/23/1997 |
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K974038 |
10/24/1997 |
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K974103 |
10/31/1997 |
ABBOTT AXSYM TROPONIN-I |
ABBOTT LABORATORIES |
LAURA L GRANITZ |
| K973811 |
10/07/1997 |
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) |
ABSOLUTE QUALITY LEADERSHIP, INC. |
DONNA DI GANGI |
| K973767 |
10/02/1997 |
HARMONIC IMAGING WITH CONTRAST |
ACUSON CORP. |
WILLIAM WELCH |
| K973981 |
10/20/1997 |
SAFEPASS STERILIZATION POUCH |
ADROIT MEDICAL SYSTEMS, INC. |
RICHARD L STUDER |
| K974010 |
10/21/1997 |
ADVANTAGE EMG SYSTEM, MODEL #A100 |
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
ROBERT SNOW |
| K973736 |
10/01/1997 |
AESCULAP HILAN MOTOR SYSTEM |
AESCULAP, INC. |
MARY E HOLDEN |
| K973953 |
10/16/1997 |
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
| K973967 |
10/17/1997 |
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) |
ALDEN OPTICAL LABS., INC. |
MARTIN DALSING |
| K973850 |
10/08/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K973851 |
10/08/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K974061 |
10/27/1997 |
RECHARGEABLE BATTERY PART NUMBER GL825-200 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K974027 |
10/23/1997 |
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK |
ALFA BIOTECH (UK) LTD. |
M. JOHN TAYLOR |
| K973770 |
10/02/1997 |
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K973873 |
10/10/1997 |
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 |
AMERICAN TELECARE, INC. |
GERARD J PRUD'HOMME |
| K973957 |
10/16/1997 |
DBEST ONE-STEP HCG SERUM/URINE TEST |
AMERITEK, INC. |
K C YEE |
| K974042 |
10/24/1997 |
AMSURE CLEANSING ENEMA SET |
AMSINO INTL., INC. |
RICHARD Y LI |
| K974045 |
10/24/1997 |
VENNETO |
AMSURE SPORTS, INC. |
WENDY W.C. SIU |
| K973980 |
10/20/1997 |
ACU-STIM TENS, AP-101082T |
APEX MEDICAL CORP. |
DANIEL LEE |
| K973978 |
10/20/1997 |
MICRO II MICROCURRENT TENS |
APEX MEDICAL CORP. |
DANIEL LEE |
| K973979 |
10/20/1997 |
MULTI-STIM TENS, AP-101081T |
APEX MEDICAL CORP. |
DANIEL LEE |
| K973891 |
10/14/1997 |
LAPAROSCOPIC GASTROSTOMY KIT |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
| K973893 |
10/14/1997 |
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
| K973950 |
10/16/1997 |
RETINAL CUBE |
APPLIED SPECTRAL IMAGING, LTD. |
MICHAEL ADEL |
| K973812 |
10/07/1997 |
ARTHREX PUDDU OSTEOTOMY SYSTEM |
ARTHREX, INC. |
SCOTT M DURLACHER |
| K973872 |
10/10/1997 |
ATRION MEDICAL COATED LACRIMAL INTUBATION SET |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARK |
| K973741 |
10/01/1997 |
BAIR HUGGER BLOOD/FLUID WARMER |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
| K973829 |
10/07/1997 |
IRRIGATION BOTTLE |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K973760 |
10/02/1997 |
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE |
AVECOR CARDIOVASCULAR, INC. |
DENNIS E STEGER |
| K973846 |
10/08/1997 |
AIR CONDUCTION HEARING AID |
BARON TRADING, INC. |
PHILLIP RECHISTER |
| K973921 |
10/15/1997 |
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K974006 |
10/21/1997 |
BECTON DICKINSON TWINPAK |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
GREG MORGON |
| K973743 |
10/01/1997 |
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
MICHELE Z BURTNESS |
| K973966 |
10/17/1997 |
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
SHELLIE GUST |
| K974075 |
10/29/1997 |
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
JAN OLSEN |
| K973932 |
10/15/1997 |
BECKMAN CALIBRATOR 2 (CAL2) |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K973928 |
10/15/1997 |
BECKMAN URINE PROTEIN CALIBRATOR (UCAL) |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K974110 |
10/31/1997 |
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K973813 |
10/07/1997 |
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K974050 |
10/24/1997 |
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K973832 |
10/07/1997 |
OPUS HLH CONTROLS |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K973948 |
10/16/1997 |
DUALINE 100 BTE |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K974069 |
10/28/1997 |
OPUS 2 - CANAL SERIES (ITC) |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K974106 |
10/31/1997 |
ICON IMPLANT SYSTEM |
BIO SCIENCE TECHNOLOGIES, INC. |
ALAN DONALD |
| K973883 |
10/14/1997 |
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K974076 |
10/29/1997 |
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K973857 |
10/09/1997 |
FLOSTAT VASCULAR REPORT GENERATOR (VRG) |
BIOMEDIX, INC. |
DAVID LERNER |
| K973819 |
10/07/1997 |
VIDAS D-DIMER (DD) ASSAY |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K973775 |
10/03/1997 |
HARPOON SUTURE ANCHORS |
BIOMET, INC. |
MARY VERSTYNEN |
| K973784 |
10/03/1997 |
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K973922 |
10/15/1997 |
ARCHIMED 4210 AND 4220 |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K974079 |
10/29/1997 |
FORMULA FOR ARCHIMED |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K974097 |
10/30/1997 |
PERIACRYL |
BLACKLOCK MEDICAL PRODUCTS, INC. |
DON BLACKLOCK |
| K973973 |
10/20/1997 |
ELECSYS CALLCHECK DIGOXIN |
BOEHRINGER MANNHEIM CORP. |
JODY J SAVAGE |
| K973788 |
10/06/1997 |
MICROVASIVE LIPTHOTRIPSY PROBES |
BOSTON SCIENTIFIC CORP. |
CAROL J HOLLOWAY |
| K973826 |
10/07/1997 |
SPHINCTEROTOME |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLON |
| K973818 |
10/07/1997 |
T-REX BIOPSY FORCEPS |
BOSTON SCIENTIFIC CORP. |
JOCELYN KERSTEN |
| K973962 |
10/16/1997 |
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS |
C.R. BARD, INC. |
SANDRA PERREAND |
| K974638 |
10/10/1997 |
STERITITE SEALED CONTAINERS MODEL SCO4Q |
CASE MEDICAL, INC. |
LARRY R PILOT |
| K973839 |
10/08/1997 |
DISPOSABLE ESOPHAGEAL STETHOSCOPE |
CATHETER RESEARCH, INC. |
JOHN A STEEN, PH.D. |
| K973776 |
10/03/1997 |
REFLECTIONS |
CDB CORP. |
SYLVIA C JOYCE |
| K974029 |
10/23/1997 |
ACS TOBRAMYCIN |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K973820 |
10/07/1997 |
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE |
CIRCON CORP. |
ANDREW D SIMONS |
| K973746 |
10/01/1997 |
PRE-FILLED SYRINGE FOR KOALA IUP |
CLINICAL INNOVATIONS, INC. |
DEAN WALLACE |
| K974085 |
10/29/1997 |
COBE OXYGENATOR PRODUCTS |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K973936 |
10/15/1997 |
FOCUS RTP SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
| K973860 |
10/09/1997 |
OVULON MONITOR |
CONCEPTION TECHNOLOGY, INC. |
TERRY R KNAPP, MD |
| K974028 |
10/23/1997 |
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING |
CONCEPTUS, INC. |
CONNIE ACUFF |
| K973890 |
10/14/1997 |
UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE |
CONMED CORP. |
IRA D DUESLER, JR |
| K973806 |
10/06/1997 |
DUODERM HYDROACTIVE GEL |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973807 |
10/06/1997 |
DUODERM HYDROACTIVE PASTE |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973845 |
10/08/1997 |
CORDIS HYDRONOL STEERABLE GUIDEWIRE |
CORDIS CORP. |
JACQUELINE ZIMOVAN |
| K973836 |
10/08/1997 |
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM |
CROSS MEDICAL PRODUCTS, INC. |
PHIL MELLINGER |
| K973974 |
10/20/1997 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE INTL., INC. |
BETTY HERNANDEZ-LABADIE |
| K973840 |
10/08/1997 |
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER |
DAIG CORP. |
DEAN BRUHN-DING, RAC |
| K973954 |
10/09/1997 |
IMAGEN RESPIRATORY SCREEN |
DAKO DIAGNOSTICS LTD. |
ELISABETH SILVER |
| K974114 |
10/31/1997 |
DASH, VITAL GARD |
DASH MEDICAL GLOVES SDN BHD |
ROBERT J SULLIVAN |
| K973985 |
10/20/1997 |
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K974101 |
10/30/1997 |
DATEX-ENGSTROM NETWORK |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K974015 |
10/22/1997 |
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL |
DAVIS & GECK, INC. |
STEPHEN J TAMSETT |
| K974057 |
10/27/1997 |
DENTEK LD 15 LASERSYSTEM |
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. |
ROBERT W BAUER |
| K973781 |
10/03/1997 |
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K973782 |
10/03/1997 |
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K974035 |
10/24/1997 |
CENTURY ALLOY |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K974044 |
10/24/1997 |
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K974117 |
10/31/1997 |
PELVX DONUT, PELVX CUBE |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
| K974116 |
10/31/1997 |
PELVX INCONTINENCE RING |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
| K974115 |
10/31/1997 |
PELVX RING, PELVX RING WITH SUPPORT |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
| K974003 |
10/21/1997 |
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974053 |
10/27/1997 |
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974001 |
10/21/1997 |
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973999 |
10/21/1997 |
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974002 |
10/21/1997 |
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973933 |
10/15/1997 |
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973931 |
10/15/1997 |
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974000 |
10/21/1997 |
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973810 |
10/07/1997 |
DRG LARGE SCREW SYSTEM |
DOLPHIN MEDICAL TECHNOLOGIES, INC. |
MARK G URBANSKI |
| K973949 |
10/16/1997 |
PERIOPERATIVE DATA MANAGEMENT SYSTEM |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K973757 |
10/02/1997 |
D.O.R.C. SOLUX LIGHT SOURCE |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K973833 |
10/07/1997 |
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL |
DYNARAD CORP. |
RAYMOND MANEZ |
| K974086 |
10/29/1997 |
KODAK DIGITAL SCIENCE CARDIAC VIEWER |
EASTMAN KODAK COMPANY |
MARK SMITH |
| K974107 |
10/31/1997 |
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) |
EASTMAN KODAK COMPANY |
NANCY BUTCHER |
| K973923 |
10/15/1997 |
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI ELECTRO BIOLOGY |
JON CAPAROTTA |
| K973934 |
10/15/1997 |
SUNGLASSES |
ELEGANCE OPTICAL MANUFACTORY, LTD. |
ESTER LAI |
| K973809 |
10/06/1997 |
FOUNDATION FRACTURE STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K974095 |
10/30/1997 |
FOUNDATION POROUS COATED FLARED RIM SHELL |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K974093 |
10/30/1997 |
FOUNDATION POROUS COATED HEMISPHERICAL SHELL |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K973803 |
10/06/1997 |
FLEXVIEW CO2 BLOWER WITH MIST |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
| K974098 |
10/30/1997 |
PUBOUURETHRAL SLING |
ETHICON, INC. |
GREGORY R JONES |
| K973998 |
10/21/1997 |
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE |
EVERRISE GLOVE PRODUCTS CO., LTD. |
JASON CHANG |
| K973902 |
10/14/1997 |
VINYL PATIENT EXAMINATION GLOVES POWDERED |
EVERRISE GLOVE PRODUCTS CO., LTD. |
JASON CHANG |
| K974008 |
10/17/1997 |
PFLEIDERER'S INTRATYMPANIC CATHETER |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K974007 |
10/21/1997 |
SHAH PERMAVENT |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K973756 |
10/02/1997 |
EYE SYS VISTA |
EYESYS TECHNOLOGIES, INC. |
BETH A SOPER |
| K973884 |
10/14/1997 |
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE |
FRANTZ DESIGN, INC. |
DONALD FRANTZ |
| K974090 |
10/29/1997 |
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS |
FRESENIUS MEDICAL CARE NORTH AMERICA |
TOM FOLDEN |
| K973924 |
10/15/1997 |
FRIOS BONESHIELD |
FRIATEC AG |
ROBERT J SLOMOFF |
| K973844 |
10/08/1997 |
GASTRIC AND RECTAL CATHETERS |
G & J ELECTRONICS, INC. |
SAM JUNDLER |
| K973941 |
10/15/1997 |
IMMUNOWELL EBNA IGG TEST |
GenBio |
Bryan Kiehl |
| K973940 |
10/15/1997 |
IMMUNOWELL EBV VCA IGG TEST |
GenBio |
Bryan Kiehl |
| K973939 |
10/15/1997 |
IMMUNOWELL VCA IGM TEST |
GenBio |
Bryan Kiehl |
| K973910 |
10/14/1997 |
GLIADIN ANTIBODIES ELISA |
GENESIS DIAGNOSTICS LTD. |
MICHAEL WALKER |
| K973825 |
10/07/1997 |
MIDSTREAM HOME REGNANCY TEST |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
| K974084 |
10/29/1997 |
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT |
GETINGE/CASTLE, INC. |
TREVOR WILLIAMSON |
| K973871 |
10/10/1997 |
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K973778 |
10/03/1997 |
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES |
HARTALEGA SDN BHD |
KAM H KUAN |
| K973823 |
10/07/1997 |
PR 3 ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH CALIFANO |
| K973822 |
10/07/1997 |
VIRGO ANCA SCREEN KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K973824 |
10/07/1997 |
VIRGO PANCO KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K973955 |
10/16/1997 |
HERNIAMESH SURGICAL MESHES |
HERNIAMESH |
LORENA A TRABUCCO |
| K974087 |
10/29/1997 |
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT |
HEWLETT-PACKARD CO. |
RAY STELTING |
| K973863 |
10/09/1997 |
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR |
HI-TRONICS DESIGNS, INC. |
JACQUES P SCHWARTZ |
| K973849 |
10/08/1997 |
BIOABSORBABLE BANKART TACK |
HOGAN & HARTSON |
JONATHAN S KAHAN |
| K974048 |
10/24/1997 |
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K974058 |
10/27/1997 |
FS IV MINI C-ARM SYSTEM |
HOLOGIC, INC. |
Nandini Murthy |
| K974056 |
10/27/1997 |
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP |
HOLOPACK INTERNATIONAL, LP |
JOHN J BARTHE |
| K974054 |
10/27/1997 |
DISTAL CENTRALIZER, EXETER II HIP SYSTEM |
HOWMEDICA, INC. |
FRANK MAAS |
| K973982 |
10/20/1997 |
ORBITAL RECONSTRUCTION PLATES |
HOWMEDICA, INC. |
VIVIAN KELLY |
| K973927 |
10/15/1997 |
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL |
HYUNJAE CORP. |
DAN MODICA |
| K973771 |
10/02/1997 |
DENTAL/SURGICAL DRILLS, BURS, TAPS |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K974074 |
10/29/1997 |
INFUSION DYNAMICS POWER INFUSER |
INFUSION DYNAMICS, INC. |
THOMAS BECZE |
| K973874 |
10/10/1997 |
ACL CLIP-IN PLATE |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
| K974049 |
10/24/1997 |
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN PAGE |
| K973855 |
10/09/1997 |
IT HYDROCOLLOID WITH ZINC |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD COX |
| K973755 |
10/02/1997 |
PILOT TUBE REPAIR KIT |
INSTRUMENTATION INDUSTRIES, INC. |
EDWARD C HOREY, JR. |
| K974060 |
10/27/1997 |
MINISTRIP/ SERUM AND URINE COMBO HCG TEST |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
| K974059 |
10/27/1997 |
ONE STEP MIDSTREAM HCG PREGNANCY TEST |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
| K974009 |
10/21/1997 |
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
| K974077 |
10/29/1997 |
VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. |
J. MORITA USA, INC. |
TERRY G MAHN |
| K973881 |
10/14/1997 |
PROSPECTOR PLUS (CODE NAME : RD-0508) |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
| K974119 |
10/31/1997 |
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) |
JACK'S ELECTRODES |
ANTHONY FENDER |
| K974080 |
10/29/1997 |
CRITIKON SOFT BLOOD PRESSURE CUFF |
JOHNSON & JOHNSON MEDICAL, INC. |
DARLENE T KORAB |
| K973774 |
10/03/1997 |
CODMAN HAKIM MICRO PRECISION VALVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K974088 |
10/30/1997 |
CODMAN INTRACRANIAL BOLT |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JAMES M FLAHERTY JR. |
| K973909 |
10/14/1997 |
KSEA ENDOTIP SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K973876 |
10/10/1997 |
PROPHYFLEX 2, MODEL 2012 |
KAVO AMERICA |
GREGORY W BOWMAN |
| K973915 |
10/14/1997 |
INFLATABLE POSITIONING CUSHIONS |
KCI NEW TECHNOLOGIES, INC. |
JUDITH A HARBOUR |
| K973763 |
10/02/1997 |
KENDALL CURITY IODOFORM PACKING STRIP |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K973827 |
10/07/1997 |
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION |
KIMBERLY-CLARK CORP. |
LARRY K LUDT |
| K973797 |
10/06/1997 |
BREATHING CIRCUIT BACTERIAL FILTER |
KING SYSTEMS CORP. |
BRUCE E GREEN |
| K973901 |
10/14/1997 |
17 B-ESTRADIOL (ELISA) |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K973897 |
10/14/1997 |
DHEA-S |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K973898 |
10/14/1997 |
PROGESTERONE ELISA |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K973900 |
10/14/1997 |
TESTOTERONE ELISA |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K973853 |
10/08/1997 |
KOLPLAST VAGINAL SPECULUM |
KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
E J SMITH |
| K974089 |
10/29/1997 |
ALLOY PRIMER |
KURARAY AMERICA, INC. |
KEJI FUJITA |
| K974004 |
10/21/1997 |
AUTOMATED DISPOSABLE KERATOME (ADK) |
LASERSIGHT TECHNOLOGIES, INC. |
CHARLES STEWART |
| K973951 |
10/16/1997 |
LEVO COMPACT-EASY LCE |
LEVO USA |
THOMAS RAEBER |
| K973758 |
10/02/1997 |
BIOSCREW ABSORBABLE INTERFERENCE SREW |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K973861 |
10/09/1997 |
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 |
MAGNATONE HEARING AID CORP. |
DON E K. CAMPBELL |
| K973984 |
10/20/1997 |
RAC 2A MODULE HOUSING |
MARQUETTE MEDICAL SYSTEMS, INC. |
DIANNE SCHMITZ |
| K973847 |
10/08/1997 |
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS |
MARTIN DALSING |
MARTIN J DALSING |
| K973887 |
10/14/1997 |
MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K973986 |
10/20/1997 |
MECTEST |
MECO INDUSTRIES |
EUGENE A ESGNERRA |
| K973919 |
10/15/1997 |
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) |
MEDENTAL INTL. |
DEBRA GILLASPY |
| K973865 |
10/06/1997 |
BIRTCHER UV LAMP |
MEDFAXX, INC. |
BOB JOHNSON |
| K973970 |
10/17/1997 |
SPO2 FINGER PROBES |
MEDICAL CABLES, INC. |
CHRISTOPHER J FONTANA |
| K973888 |
10/14/1997 |
SMARTLOCK SAFETY SYRINGE |
MEDICAL INNOVATION LTD. |
DANIEL A KRACOV |
| K974034 |
10/23/1997 |
PORTABLE INTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K973787 |
10/06/1997 |
MEDRAD 1.5T EXTREMITY ARRAY |
MEDRAD, INC. |
MARY A GREENAWALT |
| K974062 |
10/27/1997 |
MEDSCI 3% GLUTARALDEHYDE |
MEDSCI, INC. |
ROBERT MCINTOSH JR. |
| K973842 |
10/08/1997 |
CARBON FIBER CONFORMAL COUCH TOP |
MEDTEC, INC. |
DONALD F RIIBE |
| K974067 |
10/27/1997 |
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS REIGLE |
| K973991 |
10/21/1997 |
METRON QA-510 SPO2 ANALYZER |
METRON U.S., INC. |
E.J. Smith |
| K973761 |
10/02/1997 |
MICRO-STRIP FOR OPIATE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K974066 |
10/27/1997 |
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS |
MICROLINE PENTAX, INC. |
HUGHES DE LAFORCADE |
| K973765 |
10/02/1997 |
BIO-2000 |
MICRYLIUM LABORATORIES |
THAD J OVERMYER, DMD |
| K973800 |
10/06/1997 |
23:1 REDUCTION ANGLE |
MIDWEST DENTAL PRODUCTS CORP. |
ROBERT E BOOTH |
| K974022 |
10/14/1997 |
VAPR |
MITEK PRODUCTS |
EDWARD F KENT |
| K974102 |
10/31/1997 |
MILTRA IMAGING INC., IMAGE VAULT |
MITRA IMAGING, INC. |
GARY J ALLSEBROOK |
| K973963 |
10/16/1997 |
120 LEAF MULTILEAF COLLIMATOR |
MITSUBISHI ELECTRONICS AMERICA, INC. |
T W ATHEY |
| K973916 |
10/14/1997 |
NP MEDICAL CAPLESS LUER ACTIVATED VALVE |
N.P. MEDICAL, INC. |
PAUL A CARACCIOLO |
| K974047 |
10/24/1997 |
ACCUWELL PHENYLALANINE ASSAY |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K973929 |
10/15/1997 |
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM |
NEOTONUS, INC. |
JAMES R VEALE |
| K973740 |
10/01/1997 |
ROUND WINDOW E-CATH |
NEURO-BIOMETRIX, INC. |
MICHAEL H ARENBERG |
| K973764 |
10/02/1997 |
TEMPERATURE DIAGNOSTIC ACCESSORY |
NEW STAR LASERS, INC. |
DAVE HENNINGS |
| K973828 |
10/07/1997 |
PRIMA KTP LASER SYSTEM |
NIDEK, INC. |
KEN KATO |
| K973918 |
10/15/1997 |
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K973789 |
10/06/1997 |
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC |
NORIAN CORP. |
SUSANNE T SMITH |
| K973848 |
10/08/1997 |
IBU, INTEGRATED BRACHY THERAPY UNIT |
NUCLETRON CORP. |
RALPH E SHUPING |
| K973786 |
10/06/1997 |
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE |
NW RADIATION THERAPY PRODUCTS |
TERENCE ELLARD |
| K974083 |
10/29/1997 |
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS |
OHMEDA MEDICAL |
JING ZHANG |
| K973896 |
10/14/1997 |
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM |
OHMEDA MEDICAL |
CHARLES MORREALE |
| K973959 |
10/16/1997 |
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE |
OLICON IMAGING SYSTEMS, INC. |
HERMAN OOSTERWIJCK |
| K973793 |
10/06/1997 |
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE |
OLICON IMAGING SYSTEMS, INC. |
HERMAN OOSTERWIJCK |
| K973750 |
10/01/1997 |
STC CANNABINOIDS MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K973944 |
10/16/1997 |
ORTHOFIX FEMORAL NAILING SYTEM |
ORTHOFIX SRL |
ROBERT L SHERIDAN |
| K973868 |
10/10/1997 |
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K973886 |
10/14/1997 |
OTICON DIGISOUND COMPACT |
OTICON, INC. |
PREBEN BRUNVED |
| K973885 |
10/14/1997 |
OTICON DIGISOUND ITE |
OTICON, INC. |
PROBEN BRUNVED |
| K973976 |
10/20/1997 |
EPIC-FLO |
PARKELL, INC. |
NELSON J GENDUSA |
| K973864 |
10/09/1997 |
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO |
PAUSCH CORP. |
KENNETH J H. RICE |
| K973834 |
10/08/1997 |
CS2000 & CS2000 TOMO |
PAUSCH CORP. |
KENNETH TICE |
| K973972 |
10/20/1997 |
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) |
PERFECT EAR |
DON CAMPBELL |
| K974082 |
10/29/1997 |
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE |
PERFORMANCE PLUS, INC. |
CAROLANN KOTULA |
| K973835 |
10/08/1997 |
PHILIPS EASYVISION WORKSTATION |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K973983 |
10/20/1997 |
PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K974096 |
10/30/1997 |
CRX DIAMOND VALVE |
PHOENIX BIOMEDICAL CORP. |
DAVID KUNIN |
| K974070 |
10/28/1997 |
PHYSIO/1000 |
PHYSIO DESIGNS, INC. |
JAMES M TERRACCIANO |
| K974016 |
10/22/1997 |
CERCLAGE CABLE WITH HEX BUTTON |
PIONEER SURGICAL TECHNOLOGY |
BURNS O SEVERSON |
| K973958 |
10/16/1997 |
GENERAL PURPOSE ATL NEEDLE GUIDE KIT |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K974014 |
10/22/1997 |
PULPDENT DENTASTIC UNO |
PULPDENT CORP. |
KENNETH J BERK |
| K973913 |
10/14/1997 |
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE |
PWA INDUSTRIES SDN. BHD. |
AZMAN ISMAIL |
| K973780 |
10/03/1997 |
PERSONAL LUBRICATING LIQUID |
QUALIS, INC. |
MARY A FINN |
| K973894 |
10/14/1997 |
IMMUSURE |
QUANTIMETRIX CORP. |
EVY JOHNSON |
| K973858 |
10/09/1997 |
CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO |
QUIDEL CORP. |
Robin Weiner |
| K973841 |
10/08/1997 |
QUICKVUE ONE-STEP HCG-COMBO |
QUIDEL CORP. |
ROBING WEINER |
| K974052 |
10/27/1997 |
QUICKVUE SEMI-Q HCG-COMBO |
QUIDEL CORP. |
Robin Weiner |
| K974111 |
10/31/1997 |
QUIDEL CH50 EQ EIA |
QUIDEL CORP. |
Robin Weiner |
| K974108 |
10/31/1997 |
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) |
QUIDEL CORP. |
EDWARD J MCMULLEN |
| K973995 |
10/21/1997 |
RANDOX BILIRUBIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K973993 |
10/21/1997 |
RANDOX CREATININE |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K973988 |
10/21/1997 |
RDI HOMOGENEOUS HDL CHOLESTEROL TEST |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K974380 |
10/21/1997 |
REJUVENESS |
REJUVENESS PHARAMCEUTICALS, INC. |
RICHARD A PICCOLO |
| K974064 |
10/27/1997 |
MICRO X RESIDUAL TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
WALTER JANSEN |
| K974426 |
10/27/1997 |
POTENCY TEST STRIPS, INDICATOR TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
WALTER B JANSEN |
| K974081 |
10/29/1997 |
RESOUND STEALTH CIC |
RESOUND CORP. |
KRISTA M BUCKLES |
| K973875 |
10/10/1997 |
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K973920 |
10/15/1997 |
STARDUST |
RESPIRONICS, INC. |
RAJI S KASBEKAR |
| K973943 |
10/16/1997 |
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K973892 |
10/14/1997 |
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) |
RUSCH INTL. |
JAMES R WHITNEY |
| K974021 |
10/22/1997 |
SIGNAL PREGNANCY TEST KIT |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K973792 |
10/06/1997 |
EASYSAFE RETRACTING NEEDLE SYRINGE |
SAF-T-MED, INC. |
JAMES ERBS |
| K973830 |
10/07/1997 |
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE |
SAFE GLOVE LTD. |
ED SING |
| K973831 |
10/07/1997 |
PRE-POWDERED PATIENT EXAMINATION GLOVE |
SAFE GLOVE LTD. |
ED SING |
| K973911 |
10/14/1997 |
2 GALLON ALTERNATE CARE SHARPS CONTAINER |
SAGE PRODUCTS, INC. |
KAREN PINTO |
| K973791 |
10/06/1997 |
ABC CALIBRATION VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
STEVE CHIAMORI |
| K973790 |
10/06/1997 |
ABC LINEARITY VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
ROY F SCHALL JR. |
| K973751 |
10/01/1997 |
MT-200 |
SCHILLER AMERICA, INC. |
MARKUS MARITZ |
| K974039 |
10/16/1997 |
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
| K974122 |
10/31/1997 |
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA |
SCIENTIFIC HEALTH CARE |
HENRY WOO |
| K973749 |
10/01/1997 |
FRAG COMMANDER |
SCIERAN TECHNOLOGIES, INC. |
ROD ROSS |
| K973945 |
10/16/1997 |
LUGE GUIDE WIRE |
SCIMED LIFE SYSTEMS, INC. |
JILL TOWNSEND |
| K973996 |
10/21/1997 |
CLEARLINE PLUS, DENTAL WATERLINE FILTER |
SCITECH SOLUTIONS, INC. |
CLIVE DEFTY |
| K973742 |
10/01/1997 |
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
SENDX MEDICAL, INC. |
RUBEN CHAIREZ |
| K973914 |
10/14/1997 |
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR |
SENSE TECHNOLOGY, INC. |
|
| K974121 |
10/31/1997 |
LUBRICATED BAGGY TACTYLON CONDOM |
SENSICON CORP. |
JEFF D GRANT |
| K973938 |
10/15/1997 |
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER |
SFRI, INC. |
GERALD ODSTRCHEL |
| K974120 |
10/31/1997 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI SUPER GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K973802 |
10/06/1997 |
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM |
SHIMADZU MEDICAL SYSTEMS |
YASUHARU ISHII |
| K973799 |
10/06/1997 |
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K973971 |
10/17/1997 |
KION ANESTHESIA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DAVID SIMARD |
| K973917 |
10/15/1997 |
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K974013 |
10/22/1997 |
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K973862 |
10/09/1997 |
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS |
SIMS DELTEC, INC. |
LISA STONE |
| K973856 |
10/09/1997 |
GIOTTO HT |
SITCO, INC. |
ROBERT H MCCARTHY |
| K973965 |
10/17/1997 |
SMART MOTORIZED VIEWER |
SMARTLIGHT, LTD. |
DAN BEN-ZEEV |
| K973747 |
10/01/1997 |
CONTROLLED TEMPERATURE CABINET SYSTEM |
SMITH |
DURWARD FARIES, JR. |
| K973748 |
10/01/1997 |
TEMPO AND TEMP H20 |
SMITH |
DURWARD FARIES, JR. |
| K973843 |
10/08/1997 |
MSI PRESSURE INFUSOR |
SMITH ASSOC. |
E.J. Smith |
| K973854 |
10/03/1997 |
ORION ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K974017 |
10/22/1997 |
TIMESH SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K973880 |
10/14/1997 |
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM |
SONIX TECHNOLOGIES, INC. |
JEANNETTE SELOOVER JOHNSON |
| K973798 |
10/06/1997 |
S-357 VIDEO IMAGING SYSTEM |
SOPRO |
PIERRE MONTILLOT |
| K973796 |
10/06/1997 |
S-41 &41S VIDEO IMAGING SYSTEM |
SOPRO |
PIERRE MONTILLOT |
| K973795 |
10/06/1997 |
S-52 ELECTRONIC VIDEO LAPAROSCOPE |
SOPRO |
PIERRE MONTILLOT |
| K973794 |
10/06/1997 |
S-57 VIDEO IMAGING SYSTEM |
SOPRO |
PIERRE MONTILLOT |
| K974020 |
10/22/1997 |
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM |
SPINAL CONCEPTS, INC. |
TEENA M AUGOSTINO |
| K973815 |
10/07/1997 |
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM L AIK |
| K973801 |
10/06/1997 |
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM L AIK |
| K973904 |
10/14/1997 |
POLYMER LATEX EXAMINATION GLOVES |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973903 |
10/14/1997 |
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973805 |
10/06/1997 |
IMAGEACCESS SYSTEM |
STORCOMM, INC. |
GEORGE M TREIBER |
| K973837 |
10/08/1997 |
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL |
SULZER ORTHOPEDICS, INC. |
SHAVAWN EVANS PARDUHN |
| K974105 |
10/31/1997 |
KERR COMPOMER |
SYBRON DENTAL SPECIALTIES, INC. |
WENDY A URTEL |
| K974068 |
10/28/1997 |
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL |
TECNOL MEDICAL PRODUCTS, INC. |
RUTH JONES |
| K974030 |
10/23/1997 |
CARPAL ENGAGING WRIST FUSION PLATE |
TERRAY CORP. |
TEAL RENALS |
| K974025 |
10/23/1997 |
ANSPACH SHIELDED ATTACHMENT |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH III |
| K974036 |
10/24/1997 |
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE |
THE PROMETHEUS GROUP |
RICHARD HORTON |
| K973882 |
10/14/1997 |
EL-B2GP1SCR |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K974065 |
10/27/1997 |
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) |
TILLOTSON HEALTHCARE CORP. |
EDWARD MARKOVIC |
| K974040 |
10/24/1997 |
C3 EXTERNAL MALE BLADDER CONTROL DEVICE |
TIMM RESEARCH CO. |
DAVID ANDERSON |
| K973908 |
10/14/1997 |
AUKLET CT SCANNER, TSX-003A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K973814 |
10/07/1997 |
TRUMP-IT II AND MAGNUM 250 |
VALLEY WEST, INC. |
JULIE H BYERLY |
| K973889 |
10/14/1997 |
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE |
VARIAN MEDICAL SYSTEMS, INC. |
CHARLES H WILL |
| K973960 |
10/16/1997 |
MODEL 37-185 |
VICTOREEN, INC. |
LINDA S NASH |
| K974112 |
10/31/1997 |
VACUDAP, MODEL 2000, 2001 |
VICTOREEN, INC. |
LINDA S NASH |
| K973975 |
10/20/1997 |
RESPIRTECHPRO |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
| K973773 |
10/02/1997 |
DAPELLE HAIR REMOVER |
WELLQUEST INTL., INC. |
STEVEN MISHAN |
| K974018 |
10/22/1997 |
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K974118 |
10/31/1997 |
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
| K974159 |
10/14/1997 |
OSOM HCG-URINE TEST MODEL 101 |
WYNTEK DIAGNOSTICS, INC. |
SHU-CHING CHENG |
| K973744 |
10/01/1997 |
UNICATH SP BI-PLANE (MODEL M269 & M289) |
XRE CORP. |
WAYNE V LOOMER |
