| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K993881 |
02/14/2000 |
GENX CULTURE DISH |
INTL., INC. |
MICHAEL D CECCHI |
| K993884 |
02/14/2000 |
GENX MICROTOOLS |
INTL., INC. |
MICHAEL D CECCHI |
| K994256 |
02/03/2000 |
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K001955 |
12/22/2000 |
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 |
AARON MEDICAL INDUSTRIES |
RICHARD KOZLOFF |
| K000582 |
12/05/2000 |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 |
ABBOTT DIABETES CARE INC. |
EVE CONNER |
| K003677 |
12/26/2000 |
ABX PENTRA 60C+ HEMATOLOGY ANALYZER |
ABX DIAGNOSTICS |
BRUCE H DAVIS |
| K992828 |
02/03/2000 |
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER |
ACCELERATED REHAB DESIGNS, INC. |
RANDALL POTTER |
| K992804 |
02/03/2000 |
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER |
ACCELERATED REHAB DESIGNS, INC. |
RANDALL POTTER |
| K992525 |
02/04/2000 |
ACUMED MODULAR SHOULDER SYSTEM |
ACUMED, INC. |
SHARI JEFFERS |
| K002807 |
12/01/2000 |
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING |
ACUSON CORP. |
CHALON GREEN |
| K003305 |
12/22/2000 |
PEDIATRIC INGESTASCAN |
ADAMS ELECTRONICS, INC. |
ROBERT E ADAMS |
| K003134 |
12/22/2000 |
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING |
ADRI/TECHNAM |
GEORGE H SCHERR |
| K981936 |
02/16/2000 |
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION |
ADVANCED BIOMEDICAL DEVICES, INC. |
R. EDWARD WINTERS |
| K994229 |
02/25/2000 |
VERIPATH PERIPHERAL GUIDING CATHETER |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
STACEY SIMON |
| K991392 |
02/07/2000 |
HUMAN SERUM ALBUMIN |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
GREG HOLLAND |
| K991395 |
02/15/2000 |
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
GRER HOLLAND |
| K991379 |
02/02/2000 |
QUINN'S SPERM WASHING MEDIUM |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
GREG HOLLAND |
| K992012 |
02/04/2000 |
WILTSE SYSTEM |
ADVANCED SPINE FIXATION SYSTEMS, INC. |
GREG HOLLAND |
| K992147 |
02/28/2000 |
TRIPLE-FIX SPINAL FIXATION SYSTEM |
ADVANCED SPINE TECHNOLOGY, INC. |
GORDON TAO |
| K994227 |
02/03/2000 |
ADVANTAGE HCG TEST (URINE/SERUM) |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K000159 |
02/16/2000 |
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO |
AGFA CORP. |
TIMOTHY W CAPEHART |
| K003038 |
12/15/2000 |
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A |
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
EGON PFEIL |
| K003565 |
12/20/2000 |
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A |
AGILENT TECHNOLOGIES, INC. |
GRETCHEN SOLBERG |
| K003622 |
12/18/2000 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K003621 |
12/20/2000 |
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K002122 |
12/21/2000 |
VECTOR |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K002894 |
12/05/2000 |
MEDIPRIME |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K994244 |
02/18/2000 |
CONVERTORS SURGICAL GOWNS, STERILE |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K994162 |
02/09/2000 |
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K003739 |
12/27/2000 |
ALOKA SSD-4000 |
ALOKA CO., LTD. |
CHRISTOPER BOHL |
| K991571 |
02/22/2000 |
10 CURIE IRDIUM 192, CSN00100-192 |
ALPHA-OMEGA SERVICES, INC. |
J. HARVEY KNAUSS |
| K001282 |
12/15/2000 |
AIW WATER SYSTEM FOR HEMODIALYSIS |
AMERICAN INDUSTRIAL WATER |
JOE GREENING |
| K993184 |
02/10/2000 |
R1000 SERIES INSULIN PUMP |
ANIMAS CORP. |
MONICA FERRANTE |
| K003769 |
12/22/2000 |
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| K000295 |
02/16/2000 |
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K993966 |
02/18/2000 |
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K000044 |
02/01/2000 |
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K000074 |
02/04/2000 |
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS |
ARTHROCARE CORP. |
BETTY M JOHNSON |
| K000228 |
02/22/2000 |
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K000036 |
02/04/2000 |
ENTEC REFLEX WAND 55, MODEL E4055-00 |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K003624 |
12/20/2000 |
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 |
ARTHROCARE CORP. |
BETTY M JOHNSON |
| K002031 |
12/27/2000 |
PHACOFRAGMENTATION SYSTEM MEGATRON |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
| K002182 |
12/29/2000 |
AVITA TSO/TS1 INFRARED EAR THERMOMETER |
AVITA CORPORATION |
ALLEN REICH |
| K994006 |
02/03/2000 |
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) |
AVOCET MEDICAL, INC. |
JILL FALCONE |
| K003029 |
12/04/2000 |
INFUSOMAT P |
B. BRAUN MEDICAL, INC. |
GARY A GULTAS |
| K000015 |
02/04/2000 |
BARCOMED 2MP2 |
BARCO NV |
FRANK FERGUSON |
| K003730 |
12/20/2000 |
CHEMO-AIDE DISPENSING PIN |
BAXTER HEALTHCARE CORP. |
JUDY KANNENBERG |
| K003616 |
12/12/2000 |
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
| K003245 |
12/04/2000 |
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML |
BAXTER HEALTHCARE CORP. |
LINDA COLEMAN |
| K992662 |
02/15/2000 |
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K002738 |
12/19/2000 |
BAYER RAPIDPOINT 400 SYSTEM |
BAYER CORP. |
William J Pignato |
| K003291 |
12/05/2000 |
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY |
BAYER DIAGNOSTICS CORP. |
William J Pignato |
| K000196 |
02/18/2000 |
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 |
BECKMAN COULTER, INC. |
JAN OLSEN |
| K993549 |
02/01/2000 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K993547 |
02/01/2000 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K994169 |
02/03/2000 |
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K000331 |
02/10/2000 |
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K994168 |
02/03/2000 |
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K003196 |
12/22/2000 |
SYNCHRON SYSTEMS AMMONIA REAGENT |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K003681 |
12/21/2000 |
BIO-LOGIC SLEEPSCAN NETLINK |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K003280 |
12/19/2000 |
VARIANT II TOTAL GHB |
BIO-RAD |
JACKIE BUCKLEY |
| K992537 |
02/22/2000 |
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED |
BIO-VASCULAR, INC. |
MARY KAY KESSINGER SOBCINSKI |
| K000056 |
02/24/2000 |
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS |
BIOCELL LABORATORIES, INC. |
MARC M MCKONIC |
| K993714 |
02/25/2000 |
MEMOGRAPH STAPLE, WARM SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K003240 |
12/29/2000 |
BIOMET EXTERNAL WRIST PLATE |
BIOMET, INC. |
TRACY J BICKEL |
| K003044 |
12/13/2000 |
COPELAND RESURFACING HEADS |
BIOMET, INC. |
SARA A BAILEY |
| K993972 |
02/07/2000 |
DISPOSABLE INFUSION PUMP KIT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K000334 |
02/16/2000 |
IMPACT MODULAR TOTAL HIP SYSTEM |
BIOMET, INC. |
FRED MCCLURE |
| K003363 |
12/15/2000 |
M2A 32MM TAPER SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K000335 |
02/25/2000 |
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM |
BIOMET, INC. |
FRED MCCLURE |
| K994007 |
02/04/2000 |
MALLORY/HEAD SMOOTH FEMORAL COMPONENT |
BIOMET, INC. |
TINA LAKIN |
| K000254 |
02/07/2000 |
PAR 5 ACETABULAR COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K994184 |
02/15/2000 |
PLR SPLINED REVISION STEM |
BIOMET, INC. |
TRACY J BICKEL |
| K000318 |
02/28/2000 |
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K000230 |
02/29/2000 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K994369 |
02/24/2000 |
7250 (MEGAS) |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K002449 |
12/22/2000 |
BIOTEQ I.V. (INTRAVENOUS) SET |
BIOTEQUE CORP. |
JENNIFER CHEN |
| K992930 |
02/09/2000 |
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET |
BIOTEQUE CORP. |
ALLEN REICH |
| K992708 |
02/01/2000 |
IONTOPATCH |
BIRCH POINT MEDICAL, INC. |
WALTER L SEMBROWICH |
| K003770 |
12/15/2000 |
BIRD TBIRD LEGACY VENTILATOR |
BIRD PRODUCTS CORP. |
TOM GUTIERREZ |
| K994217 |
02/28/2000 |
BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K000409 |
02/28/2000 |
MODIFICATION TO T-REX BIOPSY FORCEPS |
BOSTON SCIENTIFIC CORP. |
JOCELYN KERSTEN |
| K003100 |
12/20/2000 |
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
RON BENNETT |
| K003398 |
12/01/2000 |
WIRECLIP TORQUER |
BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY |
JOCELYN KERSTEN |
| K003611 |
12/13/2000 |
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L |
BREG, INC. |
KATHLEEN BARBER |
| K002868 |
12/08/2000 |
BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER |
C.R. BARD, INC. |
ANGELA L BUNN |
| K993818 |
02/08/2000 |
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K000225 |
02/11/2000 |
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K993834 |
02/04/2000 |
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C |
CARDIOFOCUS, INC. |
WILLIAM A KNAPE |
| K002197 |
12/27/2000 |
CARTOUCH |
CARDIONICS, INC. |
JEFF MORGAN |
| K994159 |
02/15/2000 |
HMP CONTROLS (TAS) RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
| K993978 |
02/10/2000 |
PR3 ULTRASOUND SYSTEM |
CAROLINA MEDICAL, INC. |
CARROLL L TURNER |
| K000834 |
12/14/2000 |
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO |
CASTELLINI S.P.A. |
GIULIANO LANZARINI |
| K003642 |
12/20/2000 |
PLACEMENT-PLUS |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K993633 |
02/23/2000 |
SYNTHETIC VDRL ANTIGEN |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
VICTORIA POPE |
| K993911 |
02/01/2000 |
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K993828 |
02/01/2000 |
CERALAS D10 810NM DIODE LASER |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K003455 |
12/06/2000 |
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K993951 |
02/18/2000 |
SPOT ENDOSCOPIC MARKER |
CHEK-MED SYSTEMS |
ROB WHALEN |
| K003071 |
12/13/2000 |
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
CIBA VISION CORPORATION |
TERRINA WILDER |
| K994160 |
02/04/2000 |
COALESCENT SURGICAL SUTURED-CLIP |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K002798 |
12/06/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS |
Codman & Shurtleff, Inc. |
JAMES M FLAHERTY |
| K003564 |
12/20/2000 |
HAKIM PROGRAMMER AND TRANSMITTER |
Codman & Shurtleff, Inc. |
LAURA O'GRADY |
| K993085 |
02/01/2000 |
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA |
COGENT DIAGNOTICS LTD. |
RANDY WILSON |
| K994338 |
02/03/2000 |
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K002830 |
12/27/2000 |
PELVIC MUSCLE THERAPY |
COLONIAL MEDICAL SUPPLY |
PATRICIA LEIGH, R.N. |
| K002691 |
12/08/2000 |
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE |
COM-MED INTERNATIONAL, INC. |
MICHELE VOVOLKA |
| K003175 |
12/27/2000 |
COMPUMEDICS SIESTA SYSTEM |
COMPUMEDICS LIMITED |
CONSTANCE BUNDY |
| K000116 |
02/15/2000 |
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 |
CONSOLIDATED TECHNOLOGIES, INC. |
RUSTY SEWELL |
| K003716 |
12/20/2000 |
CONFORMANCE CHEMISTRY CONTROL C3 |
CONSOLIDATED TECHNOLOGY |
RUSTY SEWELL |
| K000170 |
02/14/2000 |
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 |
CONWAY STUART MEDICAL, INC. |
THOMAS C WEHMAN |
| K001785 |
12/27/2000 |
SURGISIS PERIPHERAL VASCULAR PATCH |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
| K003781 |
12/20/2000 |
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM |
COOLTOUCH CORP. |
DONALD V JOHNSON |
| K002614 |
12/08/2000 |
ADVENT IMPLANT SYSTEM |
CORE-VENT CORP. |
WILL FISHER |
| K994153 |
02/25/2000 |
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS |
CORIN U.S.A. |
CRAIG CORRANCE |
| K000232 |
02/25/2000 |
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS |
CORIN U.S.A. |
CRAIG CORRANCE |
| K993641 |
12/14/2000 |
METALYZER, MODEL 2; METALYZER, MODEL 3 |
CORTEX BIOPHYSIK GMBH |
ART WARD |
| K992638 |
02/24/2000 |
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 |
CRITIKON COMPANY,LLC |
THOMAS ENGLISH |
| K003050 |
12/26/2000 |
CRYOSURGICAL UNIT AND ACCESSORIES |
CRYOGEN, INC. |
CHERYL L SHEA |
| K003241 |
12/13/2000 |
ECAT PET SCANNER |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K003257 |
12/22/2000 |
EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION |
CYBERCARE TECHNOLOGIES, INC. |
GORDON J PETERS |
| K002984 |
12/18/2000 |
EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION |
CYBERCARE TECHNOLOGIES, INC. |
J. TERRY DRURY |
| K994294 |
02/04/2000 |
DIMENSION TRNF FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K003209 |
12/05/2000 |
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A |
DADE BEHRING, INC. |
CATHY P CRAFT |
| K983943 |
02/18/2000 |
MICROSTREP PLUS PANEL, LEVOFLOXACIN |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K994300 |
02/10/2000 |
NASOGASTRIC TUBE HOLDER, MODEL 160 |
DALE MEDICAL PRODUCTS, INC. |
JOHN C BREZACK |
| K994122 |
02/18/2000 |
BONE GRAFT WASHER, MODEL 9090114 - 9090118 |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K993810 |
02/03/2000 |
CD HORIZON SPINAL SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K003598 |
12/21/2000 |
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 |
DATASCOPE CORP. |
JOANN WOLF |
| K000186 |
02/10/2000 |
DATEX-OHMEDA INOVENT DELIVERY SYSTEM |
DATEX-OHMEDA |
DANIEL KOSEDNAR |
| K003790 |
12/22/2000 |
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 |
DAVOL, INC. |
LUCINDA L FOX |
| K003674 |
12/08/2000 |
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP |
DAVOL, INC., SUB. C.R. BARD, INC. |
RUTH C FORSTADT |
| K992467 |
02/10/2000 |
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM |
DBA SYSTEMS, INC. |
JONATHAN S KAHAN |
| K993514 |
02/24/2000 |
DEFINITE |
DEGUSSA - NEY DENTAL, INC. |
THOMAS B CAMERON |
| K002925 |
12/20/2000 |
COOLBLU CURING LIGHT |
DENTAL SYSTEMS.COM, INC. |
SHINOBU DOI |
| K994211 |
02/04/2000 |
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 |
DENTSPLY INTL. |
WILLIAM T COUSINS |
| K002733 |
12/15/2000 |
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
DEPUY ACROMED |
FRANK MASS |
| K003797 |
12/15/2000 |
ACE AIM TTC FUSION NAIL |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K003421 |
12/01/2000 |
DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K000172 |
02/03/2000 |
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K003523 |
12/13/2000 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K001738 |
12/27/2000 |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K994415 |
02/03/2000 |
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K000207 |
02/04/2000 |
POROCOAT PRODIGY HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K994012 |
02/16/2000 |
TEMPOFIT, MODEL 02693 |
DETAX GMBH & CO. KG |
BARRY HALE |
| K002768 |
12/05/2000 |
ACAPELLA |
DHD HEALTHCARE CORP. |
LAWRENCE WEINSTEIN |
| K994356 |
02/23/2000 |
IMMUNOCYT |
DIAGNOCURE, INC. |
BRUCE F MACKLER |
| K000055 |
02/18/2000 |
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K994035 |
02/01/2000 |
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K993554 |
02/10/2000 |
YEASTEST |
DIAGNOSTIC MARKERS, INC. |
GREG HOLLAND |
| K000257 |
02/23/2000 |
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K000007 |
02/28/2000 |
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K003372 |
12/26/2000 |
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP |
DIAGNOSTIC PRODUCTS CORP. |
EDWARDS M LEVINE |
| K000006 |
02/28/2000 |
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K002128 |
12/05/2000 |
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
MICHAEL (RUSTY) NICAR |
| K994424 |
02/18/2000 |
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K993291 |
02/10/2000 |
COPALIS RUBELLA IGM |
DIASORIN, INC. |
JUDITH J SMITH |
| K991737 |
02/17/2000 |
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K981567 |
02/29/2000 |
HYBRID CAPTURE II CT/GC TEST |
DIGENE CORP. |
MARK A DEL VECCHIO |
| K992539 |
02/18/2000 |
PERCUGUARD |
DIGIT-PRO |
KEVIN SORRELS |
| K002783 |
12/05/2000 |
FIXION INTERLOCKING NAIL (FIXION IL NAIL) |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K003212 |
12/28/2000 |
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JOHNATHAN S KAHAN |
| K003215 |
12/27/2000 |
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K993224 |
02/11/2000 |
T-GEAR, MODEL TG/400-700 |
DONTECH PRODUCTS B.V. |
JAN JORENS |
| K003067 |
12/13/2000 |
CALEO |
DRAGER MEDIZINTECHNIK GMBH |
JIM BRENNAN |
| K000052 |
02/10/2000 |
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 |
DYNARAD CORP. |
RAYMONF MANEZ |
| K983928 |
02/11/2000 |
KODAK HOME HEALTH MONITORING SYSTEM |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
| K000083 |
02/03/2000 |
EBI XFIX DFS RAIL SYSTEM |
EBI, L.P. |
JONAS WILF |
| K000319 |
02/25/2000 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
JONAS WILF |
| K002616 |
12/11/2000 |
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS |
ELECTRIC MOBILITY CORP. |
WALTER F ZARZYOKI |
| K002941 |
12/04/2000 |
ACETABULAR PLATES |
ENCORE ORTHOPEDICS, INC. |
J.D. WEBB |
| K993943 |
02/04/2000 |
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K000020 |
02/03/2000 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K994425 |
02/16/2000 |
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K003452 |
12/07/2000 |
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D |
EP TECHNOLOGIES, INC. |
CHRISTINA ROWE |
| K992214 |
02/22/2000 |
OXYCON PRO |
ERICH JAEGER B.V. |
LEO DEN BAKKER |
| K000396 |
12/27/2000 |
APNOESCREEN PRO, ALPHA SCREEN PRO |
ERICH JAEGER, INC. |
LARRY MURDOCK |
| K994014 |
02/24/2000 |
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K002920 |
12/18/2000 |
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II |
ESCALON MEDICAL CORP. |
RONALD HUENEKE |
| K003170 |
12/15/2000 |
RYTHMIC AND RYTHMIC UV |
ESSILOR INTL. |
CHRISTINE MOENCH |
| K002906 |
12/15/2000 |
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
| K003587 |
12/04/2000 |
CLEARGLIDE PRECISION BIPOLAR DEVICE |
ETHICON, INC. |
GREGORY R JONES |
| K993801 |
02/07/2000 |
GYNECARE LAPAROSCOPIC MORCELLATOR |
ETHICON, INC. |
GREGORY R JONES |
| K994228 |
02/22/2000 |
REMOTEIMAGE SYSTEM |
ETRAUMA.COM CORP. |
DAN HODGEMAN |
| K000367 |
02/29/2000 |
SECURMIX |
EUROSPITAL |
FRAN WHITE |
| K994336 |
02/08/2000 |
BITX PROBES |
EVEREST MEDICAL CORP. |
FREDERICK G MADES |
| K000242 |
02/16/2000 |
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE |
EXACTECH, INC. |
GARY J MILLER |
| K992290 |
02/23/2000 |
EXEL INJECTION PLUG WITH CAP |
EXEL INTL. |
ARMAND HAMID |
| K992039 |
02/10/2000 |
EXEL I.V. BLOOD LINE SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K994416 |
02/03/2000 |
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
FLEXITECH SDN. BHD. |
Y. F HEW |
| K003582 |
12/05/2000 |
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 |
FLUIDSENSE CORP. |
THOMAS CONNELLY |
| K002884 |
12/04/2000 |
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
| K003445 |
12/01/2000 |
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K002761 |
12/04/2000 |
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K994298 |
02/18/2000 |
FRIOS MICROSAW |
FRIADENT GMBH |
CAROL PATTERSON |
| K993861 |
02/10/2000 |
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JOSEPH M AZARY |
| K993704 |
02/11/2000 |
GASTRO-INTESTINAL SYSTEM EN-410WM |
FUJINON, INC. |
GARY ADLER |
| K993965 |
02/18/2000 |
CRYO-HIT |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K003264 |
12/21/2000 |
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K993751 |
02/02/2000 |
COROMETRICS MODEL 173 FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RICHARD CEHOVSKY |
| K003849 |
12/22/2000 |
GE ADVANCE NXI PET SYSTEM |
GE MEDICAL SYSTEMS, INC. |
D DUERSTELER |
| K993037 |
02/14/2000 |
LCV+ VERSION 2 |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K000300 |
02/15/2000 |
LIGHTSPEED 2.0CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K994361 |
02/18/2000 |
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL |
GENESIS INDUSTRIES, INC. |
ANGELA RICHARDSON |
| K993553 |
02/01/2000 |
GTI-FVIII INHIBITOR ASSAY |
GENETIC TESTING INSTITUTE |
MICHAEL MOGHADDAM |
| K994314 |
02/16/2000 |
CASTLE SERIES 100HC STEAM STERILIZERS |
GETINGE/CASTLE, INC. |
MARK N SMITH |
| K002803 |
12/27/2000 |
THE O'NEIL STERILE FIELD URINARY CATHETER KIT |
GO MEDICAL INDUSTRIES PTY. LTD. |
GEORGE O'NEIL |
| K993332 |
02/16/2000 |
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 |
GRADIPORE LTD. |
RHONDA PILGRIM |
| K003000 |
12/18/2000 |
GRAMS NYLON NONABSORBABLE SUTURE |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
| K002999 |
12/18/2000 |
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
| K003001 |
12/15/2000 |
GRAMS SILK NONABSORBABLE SUTURE |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
| K003195 |
12/13/2000 |
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC |
GREER LABORATORIES, INC. |
GERALD FRIESEN |
| K000101 |
02/10/2000 |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
KOBBY DANKWAH |
| K000090 |
02/10/2000 |
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K000256 |
02/11/2000 |
CAP PORP, CAP TORP |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K003569 |
12/19/2000 |
PLASMAKINETIC ENDOUROLOGY SYSTEM |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K002947 |
12/19/2000 |
BIOMOL ASPIRATION BIOPSY NEEDLE |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
| K002944 |
12/19/2000 |
PRECISA BIOPSY NEEDLE |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
| K002946 |
12/19/2000 |
SILENT BIOPSY NEEDLE |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
| K002775 |
12/05/2000 |
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
| K001669 |
12/08/2000 |
HANGER CRANIAL BAND |
HANGER ORTHOPEDIC GROUP, INC. |
JOSEPH MCTERNAN |
| K003532 |
12/13/2000 |
HARDY DISK, CEFPODOXINE, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
| K994046 |
02/01/2000 |
HARDYDISK CEFACLOR 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000022 |
02/17/2000 |
HARDYDISK CEFAMANDOLE, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994129 |
02/11/2000 |
HARDYDISK CEFIXIME, 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994089 |
02/11/2000 |
HARDYDISK CHLORAMPHENICOL, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994135 |
02/16/2000 |
HARDYDISK ERYTHROMYCIN, 15MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994091 |
02/11/2000 |
HARDYDISK GENTAMICIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994212 |
02/15/2000 |
HARDYDISK MEZLOCILLIN 75MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994150 |
02/16/2000 |
HARDYDISK NORFLOXACIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994134 |
02/17/2000 |
HARDYDISK OXACILLIN, 1MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000182 |
02/29/2000 |
HARDYDISK TOBRAMYCIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000128 |
02/18/2000 |
HARDYDISK, CEFAZOLIN, 30MCG |
HARDY DIAGNOSTICS |
MELISSA TRAYLOR |
| K000130 |
02/29/2000 |
HARDYDISK, NALIDIXIC ACID, 30MCG |
HARDY DIAGNOSTICS |
MELISSA TRAYLOR |
| K000183 |
02/28/2000 |
HARDYDISK, PIPERACILLIN, 100MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000201 |
02/29/2000 |
HARDYDISK, STREPTOMYCIN 10MCG |
HARDY DIAGNOSTICS |
MELISSA TRAYLOR |
| K993383 |
02/03/2000 |
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K993051 |
02/03/2000 |
VERSALET 7700 CARE CENTER, MODEL # 7700 |
HILL-ROM AIR-SHIELDS |
JAMES G CARPENTER |
| K994196 |
02/10/2000 |
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM |
HORIZON MEDICAL PRODUCTS, INC. |
JOHN TARTAL |
| K994033 |
02/24/2000 |
HORTMANN ECHOMASTER OAE ANALYZER |
HORTMANN AG |
BRADFORD MELANCON |
| K002923 |
12/18/2000 |
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K993889 |
02/11/2000 |
EXETER CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K003211 |
12/15/2000 |
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K003490 |
12/08/2000 |
OPUS ROD FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K003018 |
12/15/2000 |
TITAN TIBIAL NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K001956 |
12/11/2000 |
TRIDENT ALL POLY CUP |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K994432 |
02/16/2000 |
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) |
HWA TEH INDUSTRIAL SDN. BHD. |
K. KARUNAKARAN |
| K002794 |
12/06/2000 |
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY |
HYPERTEC, INC. |
DANIEL KAMM |
| K002795 |
12/06/2000 |
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS |
HYPERTEC, INC. |
DANIEL KAMM |
| K992571 |
02/10/2000 |
I-STAT SYSTEM |
I-STAT CORP. |
PAUL VANDERWERF |
| K994117 |
02/04/2000 |
MR ENHANCER |
I.Z.I. CORP. |
E. J SMITH |
| K993742 |
02/02/2000 |
SUPER TISSUE |
I.Z.I. CORP. |
E.J. Smith |
| K002985 |
12/13/2000 |
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS |
ICS MEDICAL CORP. |
DELMAR F BLOEM |
| K003366 |
12/22/2000 |
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL |
IGC-MEDICAL ADVANCES, INC. |
MICHAEL J LEIGH |
| K001550 |
12/11/2000 |
EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR |
IMATRON, INC. |
J. A CODUTO |
| K003205 |
12/15/2000 |
TRANSFX ANGLED RODS |
IMMEDICA, INC. |
ROY BOGERT |
| K994148 |
02/01/2000 |
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K994076 |
02/18/2000 |
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY |
IMPLEX CORP. |
JOHN SCHALAGO |
| K001763 |
12/20/2000 |
CRIT-LINE MONITOR III (CLM III) |
IN-LINE DIAGNOSTICS CORP. |
MATTHEW L HAYNIE |
| K002135 |
12/06/2000 |
SLEEPSTRIP DISPOSABLE APNEA SCREENER |
INFLUENT LTD. |
JONATHAN S KAHAN |
| K002393 |
12/19/2000 |
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K002964 |
12/19/2000 |
NEURO II |
INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. |
JOEL S FADEN |
| K993785 |
02/04/2000 |
ULTRACLIP TISSUE MARKER |
INRAD |
JOSEPH M MAZUREK |
| K992657 |
02/18/2000 |
IBC VRV, MODEL 1350 |
INTERNATIONAL BIOPHYSICS CORP. |
H. DAVID SHOCKLEY, JR. |
| K002384 |
12/15/2000 |
M-XX OXYGEN SENSORS |
INTERNATIONAL BUSINESS STRATEGIES |
WILLIAM ROETTGER |
| K000236 |
02/16/2000 |
SYNERGY VLS CAP NUT MODELS 2206, 6102 |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K001211 |
12/04/2000 |
MODIFICATION TO INTRALASE 600C LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K993904 |
02/01/2000 |
INTRASTENT DOUBLESTRUT LD |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
| K003450 |
12/07/2000 |
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
| K003040 |
12/28/2000 |
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K000174 |
02/18/2000 |
ACTION AF-1 WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K003448 |
12/07/2000 |
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K000081 |
12/19/2000 |
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM |
ISOTOPES AND METALS LTD. |
GIOVANNI LEO |
| K003634 |
12/21/2000 |
DW 272 #1 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003632 |
12/20/2000 |
DW 273 #1 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003635 |
12/22/2000 |
DW 276 #3 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003633 |
12/20/2000 |
DW 277 #4 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003377 |
12/04/2000 |
FERMIT N PLUS |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003374 |
12/04/2000 |
FERMIT PLUS |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K993878 |
02/01/2000 |
JE 2000 |
JACK'S ELECTRODES |
ANTHONY R.H. FENDER |
| K003327 |
12/05/2000 |
ALBUMIN |
JAS Diagnostics, Inc. |
David Johnston |
| K003247 |
12/14/2000 |
CREATININE |
JAS Diagnostics, Inc. |
David Johnston |
| K000173 |
02/29/2000 |
CEMENT IT! UNIVERSAL C&B |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K002815 |
12/19/2000 |
GOLD CORE HF PRE SOLDER |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K003039 |
12/05/2000 |
GOLD CORE II |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K002854 |
12/20/2000 |
GOLD CORE POST SOLDER |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K003037 |
12/05/2000 |
JEWEL CAST III |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K994435 |
02/10/2000 |
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K000360 |
02/18/2000 |
RX G-UNIVERSAL |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K992445 |
02/18/2000 |
MED-GUARD SURGEON'S GOWN |
KAPPLER USA |
PHILIP C MANN |
| K993804 |
02/07/2000 |
KSEA RIGID CULDOSCOPE AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K994090 |
02/04/2000 |
KARL STORZ AUTOCLAVABLE CAMERA HEAD |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
| K993745 |
02/03/2000 |
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 |
KATECHO, INC. |
WARREN R WALTERS |
| K003228 |
12/14/2000 |
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A |
KATECHO, INC. |
WARREN R WALTERS |
| DEN990002 |
02/22/2000 |
KAVO DIAGNODENT |
KAVO AMERICA |
DOUGLAS COCHRANE |
| K000184 |
02/11/2000 |
AUDIOSCREENER OAE |
KEDLY, INC. |
RANDALL J KROHN |
| K994154 |
02/15/2000 |
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES |
KLS-MARTIN L.P. |
ARTHUR WARD |
| K003056 |
12/13/2000 |
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 |
LABOTECT LABOR-TECHNIK GOTTINGEN |
ANGELIKA ALBRECHT |
| K003483 |
12/06/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) |
LAKE REGION MFG., INC. |
JIM KLOSTERMAN |
| K003147 |
12/15/2000 |
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL HARDIMAN |
| K993912 |
02/09/2000 |
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI |
LATEXX PARTNERS, INC. |
E.J. Smith |
| K003161 |
12/15/2000 |
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT |
LES LABORATOIRES BLANCHARD |
JOHN M SZABOCSIK |
| K994205 |
02/29/2000 |
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
| K001441 |
12/18/2000 |
SATURN BLOOD GLUCOSE MONITORING TEST STRIP |
LIFESCAN, INC. |
MARY ELLEN HOLDEN |
| K993885 |
02/10/2000 |
ULTRABLATOR ELECTRODE |
LINVATEC CORP. |
LAURA SENEFF |
| DEN000004 |
02/29/2000 |
QUICKAIR CHOKE RELIEVER, MODEL 59-001A |
MAET INDUSTRIES, INC. |
WAYNE WITBECK |
| K002569 |
12/12/2000 |
GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES |
MALGAM ENT., INC. |
MICHAEL L GAMBLE |
| K002550 |
12/20/2000 |
RDH BANDAGE |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K992854 |
02/07/2000 |
ARTIFICIAL TEETH (ACRYLIC TEETH) |
MASTERDENT LTDA. |
JUAN FERNANDO SALAZAR |
| K000714 |
12/21/2000 |
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET |
MED-PRO TECHNOLOGIES, INC. |
ART WARD |
| K003110 |
12/01/2000 |
MEDCOMP BIO-CATH CATHETER LINE |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K993515 |
02/25/2000 |
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K003144 |
12/13/2000 |
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K003685 |
12/22/2000 |
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL |
MEDICAL ADVANCES, INC. |
MICHAEL LEIGH |
| K002970 |
12/12/2000 |
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 |
MEDICAL DESIGNS L.L.C. |
PAUL JOHN AXT |
| K002232 |
12/06/2000 |
AEDEFIBRILLATOR |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K991335 |
02/28/2000 |
MEDI-CULT FREEZING & THAWING PACKS |
MEDICULT A/S |
RTONALD G LEONARDI |
| K991330 |
02/25/2000 |
MEDI-CULT LIQUID PARAFFIN |
MEDICULT A/S |
RONALD LEONARDI |
| K991329 |
02/25/2000 |
MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE |
MEDICULT A/S |
RONALD G LEONARDI |
| K991333 |
02/28/2000 |
MEDI-CULT SPERM FREEZE MEDIUM |
MEDICULT A/S |
RONALD G LEONARDI |
| K994218 |
02/10/2000 |
EASY CARE AND TUBING SETS |
MEDIONICS INTERNATIONAL, INC. |
MAHESH A GARWAL |
| K994131 |
02/07/2000 |
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) |
MEDTAXX PARTNERS |
E. J SMITH |
| K003687 |
12/22/2000 |
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K000274 |
02/10/2000 |
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
JAMES BALUN |
| K992715 |
02/28/2000 |
NEURO URODYNAMIC SUITE, MODEL 9032E0101 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
ANN-CHRISTINE JONSSON |
| K000094 |
02/08/2000 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
| K000641 |
12/22/2000 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K003201 |
12/12/2000 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
RONALD K SMITH |
| K000430 |
02/25/2000 |
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 |
MEDTRONIC VASCULAR |
DEBRA KRIDNER |
| K003724 |
12/21/2000 |
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B |
MEDTRONIC VASCULAR |
MARIE HOLM |
| K000210 |
02/23/2000 |
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT |
MEDTRONIC VASCULAR |
MICHAEL JOHNSON |
| K000379 |
02/16/2000 |
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 |
MEDTRONIC VASCULAR |
MARIE HOLM |
| K002972 |
12/15/2000 |
MEROGEL CONTROL GEL ENT SURGICAL DRESSING |
MEDTRONIC XOMED |
DIANA PRESTON |
| K002224 |
12/04/2000 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED |
MARTIN D SARGENT |
| K993893 |
02/10/2000 |
MEDX INTECAM INTERFACE |
MEDX, INC. |
FLOYD ROWAN |
| K000316 |
02/24/2000 |
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI |
MERETEK |
KERRY BUSH |
| K003078 |
12/11/2000 |
MERIT DRAINAGE DEPOT |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K003815 |
12/27/2000 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K991093 |
12/21/2000 |
MSD EMBOLECTOMY BASKET |
METAMORPHIC SURGICAL DEVICES, LLC. |
GERALD G CANO |
| K993959 |
02/14/2000 |
ISOCENTRIC BEAM CHECKER |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K993960 |
02/14/2000 |
PERMA-DOC PHANTOM |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K000120 |
02/03/2000 |
PRO-TORQ |
MICRO MOTORS, INC. |
GREG HOLLAND |
| K003097 |
12/28/2000 |
BRAIN COIL, MODEL 9800GE-64 |
MIDWEST R.F. LLC. |
RALPH S HASHOIAN |
| K003386 |
12/28/2000 |
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 |
MIDWEST R.F. LLC. |
RALPH S HASHOIAN |
| K003143 |
12/11/2000 |
MILLENNIUM BLADES, MODEL MB101 |
MILLENNIUM BIOMEDICAL, INC. |
JERRY KAENI |
| K000220 |
02/24/2000 |
MA-300 ELECTROMYOGRAPHY SYSTEM |
MOTION LAB SYSTEMS, INC. |
EDMUND CRAMP |
| K993898 |
02/04/2000 |
KAC-63 KNEE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993754 |
02/09/2000 |
HSV-1 ELISA IGG, MODEL EL0910G |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K993724 |
02/01/2000 |
HSV-2 ELISA IGG, MODEL EL0920G |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K002425 |
12/21/2000 |
MEDIADENT HDX/MMD HDX SP XRAY SENSOR |
MULTI MEDIA DENTAL SYSTEMS, INC. |
SCOTT MCLAUGHLIN |
| K993762 |
02/04/2000 |
I.CO.S SCREW |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K993910 |
02/01/2000 |
TAC' PIN |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K003520 |
12/13/2000 |
NEXAN SYSTEM, MODEL NX-300 |
NEXAN LTD |
DAVID L WEST |
| K000079 |
02/04/2000 |
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M |
NIKOMED U.S.A., INC. |
ELAINE DUNCAN |
| K992699 |
02/14/2000 |
NIPRO BLOOD COLLECTION NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN HADLEY |
| K001465 |
12/05/2000 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
RICHARD D BLISS, JR. |
| K000144 |
02/11/2000 |
NIPRO INSULIN SYRINGE |
NIPRO MEDICAL CORP. |
GARY GOLDSMITH |
| K994191 |
02/08/2000 |
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T |
NMT MEDICAL, INC. |
RONALD D ARKIN |
| K992937 |
02/29/2000 |
DENTAL IMPLANT |
NOBEL BIOCARE UAS INC |
JEFF HAUSHEER |
| K993979 |
02/22/2000 |
MARSPO2, MODEL 2001 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN |
| K002403 |
12/08/2000 |
NOVOFINE 31 DISPOSABLE NEEDLE |
NOVO NORODISK PHARMACEUTICALS, INC. |
MICHAEL BARBUSH |
| K002782 |
12/05/2000 |
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION |
NUCLEAR DIAGNOSTICS AB |
JIM HOWARD |
| K003270 |
12/22/2000 |
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 |
NUCLETRON CORP. |
ROBERT APPLEBAUM |
| K003643 |
12/27/2000 |
NUMED Z-MED PTV CATHERERS |
NUMED, INC. |
NICHELLE LAFLESH |
| K003276 |
12/01/2000 |
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 |
NUMED, INC. |
NICHELLE R LAFLESH |
| K002951 |
12/08/2000 |
MAGELLAN VENTILATOR |
OCEANIC MEDICAL PRODUCTS, INC. |
WILLIAM M GATES |
| K002927 |
12/10/2000 |
SNARE,FLEXIBLE |
ODON LIFETECHNOLOGY |
J M DURAND |
| K003721 |
12/18/2000 |
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K984579 |
12/21/2000 |
CAPNO PROBE A |
OPTICAL SENSORS, INC. |
Gary J Syring |
| K000034 |
02/24/2000 |
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM |
OPTIMAL IMAGING SYSTEMS, INC. |
JORGE MILLIAN |
| K002899 |
12/12/2000 |
OPUS 20, MODEL 1ST |
OPUSDENT LTD. |
SHOSHANA FRIEDMAN |
| K001976 |
12/06/2000 |
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K000846 |
12/04/2000 |
TKD SCALERS |
ORASYSTEMS |
BERNARD SESSMAN |
| K992805 |
02/04/2000 |
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) |
ORATEC INTERVENTIONS, INC. |
JENNIFER BRENNAN |
| K994343 |
02/10/2000 |
BACT/ALERT SV |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K002989 |
12/14/2000 |
PROCLUDE |
ORTEK THERAPEUTICS, INC. |
JULES T MITCHEL |
| K001254 |
12/13/2000 |
ORTHOMATRIX, INC. CERCLAGE SYSTEM |
ORTHOMATRIX, INC. |
BEN SHAPPLEY |
| K994337 |
12/14/2000 |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
ORTHOVITA CO. |
ANGIE IDE |
| K002156 |
12/19/2000 |
APPRAISE URINE MICROALBUMIN COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K993401 |
02/28/2000 |
DRYSPOT E.COLI 0157 KIT |
OXOID, LTD. |
AMANDA SHEPPARD |
| K994255 |
02/07/2000 |
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K993779 |
02/02/2000 |
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K993781 |
02/02/2000 |
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K993782 |
02/02/2000 |
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K994100 |
02/18/2000 |
PACIFIC HEMOSTASIS THROMBOPLASTIN D |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K993918 |
02/10/2000 |
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K003141 |
12/05/2000 |
UBM PLUS, MODEL P45 |
PARADIGM MEDICAL INDUSTRIES, INC. |
TRACY S BEST |
| K002845 |
12/08/2000 |
PAFLUFOCON C AND E DAILY CONTACT LENS |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K994302 |
02/07/2000 |
RESIN TOOTH BONDING AGENT |
PARKELL, INC. |
NELSON J GENDUSA |
| K993406 |
12/18/2000 |
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 |
PERMOBIL A.B. |
BENGT PERSSON |
| K994201 |
02/07/2000 |
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
| K000131 |
02/04/2000 |
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 |
PHAMATECH |
CARL A MONGIOVI |
| K000132 |
02/18/2000 |
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K003516 |
12/27/2000 |
GYROSCAN INTERA 3.0T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K002942 |
12/19/2000 |
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K994210 |
02/04/2000 |
INTURIS SUITE |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
| K000310 |
02/15/2000 |
VOYAGER 6.0 SOFTWARE OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K001499 |
12/27/2000 |
PHORMAX EAGLE SCANNER SYSTEM |
PHORMAX CORP. |
SHEILA W PICKERING |
| K994127 |
02/03/2000 |
GLORY |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
| K992424 |
12/29/2000 |
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 |
PLASTIMED LABORATOIRE PHARMACEUTIQUE |
JEAN-DANIEL NURY |
| K993794 |
02/07/2000 |
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS |
PLAYTIME PRODUCTS, INC. |
MARK ROSENGARTEN |
| K994146 |
12/11/2000 |
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP |
PLUS ORTHOPEDICS |
DAVID W SCHLERF |
| K992815 |
02/07/2000 |
THE MARGRON HIP REPLACEMENT SYSTEM |
PORTLAND ORTHOPAEDICS PTY. LTD. |
RONALD SEKEL |
| K003277 |
12/21/2000 |
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 |
POWERMED, INC. |
MICHELE LUCEY |
| K993750 |
02/02/2000 |
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO |
PROBLEM SOLVING CONCEPTS, INC. |
THOMAS M MCCLELLAND |
| K003656 |
12/15/2000 |
X-POSURE SYSTEM VERSION 2 MAMMO |
PRONOSCO A/S |
JONATHAN S KAHN |
| K001576 |
12/28/2000 |
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY |
PROSURG, INC. |
LEE BUI |
| K003249 |
12/12/2000 |
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 |
PST, INC. |
WILLIAM NADEL |
| K000851 |
12/11/2000 |
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR |
PSYCHEMEDICS CORP. |
WILLIAM THISTLE |
| K994182 |
02/23/2000 |
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE |
PULPDENT CORP. |
KENNETH J BERK |
| K994181 |
02/29/2000 |
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE |
PULPDENT CORP. |
KENNETH J BERK |
| K994279 |
12/22/2000 |
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) |
PURE WATER SOLUTIONS, INC. |
DEAN S LEWIS |
| K003534 |
12/01/2000 |
PENTRA 5D |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K001233 |
12/13/2000 |
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S |
R-GROUP INTL. |
KERRY ANNE KAHN |
| K992689 |
02/10/2000 |
MU PLUS |
RAD THERAPY SOLUTIONS, INC. |
STEVE GRUSE |
| K001866 |
12/07/2000 |
TCM400 |
RADIOMETER MEDICAL A/S |
KRISTEN RONO |
| K000017 |
02/10/2000 |
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 |
RD MEDICAL MFG., INC. |
CARLOS A RODRIQUEZ |
| K993405 |
02/15/2000 |
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993396 |
02/15/2000 |
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993404 |
02/15/2000 |
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993395 |
02/15/2000 |
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993390 |
02/14/2000 |
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993408 |
02/15/2000 |
REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT |
REMED PHARMA |
E.J. Smith |
| K003036 |
12/22/2000 |
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 |
RETINALABS.COM |
FRANK TIGHE |
| K000365 |
02/23/2000 |
ACCU-CHEK ADVANTAGE METER |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K000364 |
02/23/2000 |
ACCU-CHEK COMPLETE METER |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K003772 |
12/20/2000 |
ELECSYS DHEA-S CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K003178 |
12/14/2000 |
ELECSYS HCG AND BETA TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K003120 |
12/18/2000 |
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K003158 |
12/18/2000 |
ROCHE DIAGNOSTICS CK-MB |
ROCHE DIAGNOSTICS CORP. |
KAY A TALOR |
| K000394 |
02/29/2000 |
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT |
ROCKET MEDICAL PLC |
LES TODD |
| K994327 |
02/28/2000 |
EMBRYON TRANSFER CATHETERS/SETS |
ROCKET MEDICAL PLC |
LES TODD |
| K003048 |
12/15/2000 |
ALL TERRAIN WHEELCHAIR (ATW) |
ROLL-ABILITY (PTY) LTD. |
VICTOR F MYBURGH |
| K992359 |
02/18/2000 |
MRS-TITAN |
ROTEC MEDIZINTECHNIK GMBH |
ING ULRICH HOLZWARTH |
| K002955 |
12/21/2000 |
EMPIRE N BLOOD PRESSURE MANOMETERS |
RUDOLF RIESTER GMBH & CO. KG |
PATRICIA RIESTER-FREUDENMANN |
| K002954 |
12/21/2000 |
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS |
RUDOLF RIESTER GMBH & CO. KG |
PATRICIA RIESTER-FREUDENMANN |
| K000070 |
02/18/2000 |
FLOCATH |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K993786 |
02/02/2000 |
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K991393 |
02/02/2000 |
HYALURONIDASE, 80 U/ML |
SAGE BIOPHARMA |
GREG HOLLAND |
| K003734 |
12/21/2000 |
SERUM PROTEIN SUBSTITUTE |
SAGE BIOPHARMA |
GRACE HOLLAND |
| K991396 |
02/15/2000 |
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L |
SAGE BIOPHARMA |
GREG HOLLAND |
| K000249 |
12/11/2000 |
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 |
SCHAEFER WATER CENTERS |
MICHAEL J SCHAEFER |
| K994379 |
02/18/2000 |
EU-TTG IGA ELISA |
SCIMEDX CORP. |
Gary Lehnus |
| K002853 |
12/04/2000 |
SCITON IMAGE HAIR REMOVAL LASER |
SCITON, INC. |
PETER ALLEN |
| K002841 |
12/08/2000 |
COOL-TEC ELECTRODES |
SEEDLING ENTERPRISES. LLC. |
PAMELA PAPINEAU |
| K003711 |
12/15/2000 |
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P |
SEIN ELECTRONICS CO., LTD. |
WON-KY KIM |
| K991397 |
02/11/2000 |
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS |
SEIN ELECTRONICS CO., LTD. |
S.H. HWANG |
| K994346 |
02/01/2000 |
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
SENDX MEDICAL, INC. |
MARTIN SELLERS |
| K994136 |
02/03/2000 |
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K992979 |
02/09/2000 |
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
JULIA WU |
| K993876 |
02/07/2000 |
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K002411 |
12/12/2000 |
SHENLING ACUPUNCTURE NEEDLES |
SHENLING MEDICAL DEVICE CO., LTD |
GEORGE SU |
| K000217 |
02/18/2000 |
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
JANNA P TUCKER |
| K000156 |
02/18/2000 |
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
JANNA P TUCKER |
| K000166 |
02/22/2000 |
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
JAMES CHU |
| K000071 |
02/29/2000 |
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
JAMES CHU |
| K994222 |
02/07/2000 |
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
GUI-XI LIU |
| K994206 |
02/07/2000 |
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
GUI-XI LIU |
| K993017 |
02/25/2000 |
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE |
SHIN CHANG MEDICAL CO., LTD. |
JAN J FRANK |
| K002391 |
12/04/2000 |
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) |
SIAM SEMPERMED CORP. LTD. |
WILLIAM HARRIS |
| K994315 |
02/04/2000 |
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K003623 |
12/21/2000 |
INTERACTIVE REAL TIME SCANNING PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K003192 |
12/21/2000 |
MAGNETIC CONCERTO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K003243 |
12/21/2000 |
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K002105 |
12/05/2000 |
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K993974 |
02/22/2000 |
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K003248 |
12/21/2000 |
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K003246 |
12/21/2000 |
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K003266 |
12/01/2000 |
SIREMOBIL ISO-C 3D |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
AMY SHAW HOSLER |
| K002506 |
12/14/2000 |
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
| K994275 |
02/22/2000 |
SIMS PORTEX ANESTHESIA CATHETER |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
| K994172 |
02/08/2000 |
CEREC 3 |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
| K992652 |
02/03/2000 |
SD-730 IF-SDS, PERFECT PULSE IF-SDS |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE K.C. CHEN |
| K994202 |
02/25/2000 |
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM |
SMITH & NEPHEW, INC. |
NICHOLAS CONDAKES |
| K992220 |
02/25/2000 |
RADIAL HEAD PROSTHESIS |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K002747 |
12/15/2000 |
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K994143 |
02/18/2000 |
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K002996 |
12/11/2000 |
SYNERGY HA COATED POROUS FEMORAL STEMS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K001160 |
12/11/2000 |
VERSABOND BONE CEMENT |
SMITH & NEPHEW, INC. |
EHAB M ESMAIL |
| K992322 |
02/02/2000 |
SNAP MODEL 5 |
SNAP LABORATORIES, L.L.C. |
GIL RAVIV |
| K002753 |
12/04/2000 |
SPARTAN A-10 |
SPARTAN ULTRASONICS, INC. |
ALDO E EAGLE |
| K992787 |
02/02/2000 |
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR |
SPECIALTY ULTRAVISION, INC. |
IVALEE I COHEN |
| K993580 |
02/02/2000 |
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
SPECIALTY ULTRAVISION, INC. |
RICHARD LIPPMAN |
| K994438 |
02/04/2000 |
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER |
SPECTRX, INC. |
JAMES R VEALE |
| K992176 |
02/10/2000 |
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL |
ST. GEORGE TECHNOLOGY, INC. |
VERNON WATKINS |
| K002976 |
12/22/2000 |
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX |
ST. JUDE MEDICAL |
DEAN BRUHN-DING |
| K000119 |
02/17/2000 |
SJM TAILOR ANNULOPLASTY RING, MODEL TARN |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
| K991613 |
12/08/2000 |
SW ULTRASOUND, MODELS 331, 311, 333 |
STARBENE |
JUDITH NIZTZSCHMAMN |
| K003169 |
12/08/2000 |
VASCULAR CLOSURE DEVICE |
STD MFG., INC. |
STEPHEN M PALUMBO |
| K003447 |
12/15/2000 |
PROTRACT PRESS FIT HIP STEM |
STELKAST COMPANY |
DONALD A STEVENS |
| K003002 |
12/08/2000 |
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K002127 |
12/29/2000 |
INJECTRITE-C15 AND INJECTRITE-C30 |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K003283 |
12/13/2000 |
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K980951 |
02/25/2000 |
ONEFLOW |
STI MEDICAL |
LAUREN R ZIEGLER |
| K994021 |
02/22/2000 |
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION |
STRIETER CLINICAL RESEARCH LABORATORIES, INC. |
JAMES F STRIETER |
| K003660 |
12/12/2000 |
LEIBINGER NEURO CLIP SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| K993990 |
02/22/2000 |
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM |
STRYKER INSTRUMENTS |
KRISTYN R KELLEY |
| K000594 |
12/08/2000 |
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE |
STRYKER LEIBINGER |
ROBIN L ROWE |
| K001491 |
12/15/2000 |
QUICKIE 2 POWER ASSIST WHEELCHAIR |
SUNRISE MEDICAL, INC. |
BRYAN DANNETTELL |
| K993190 |
02/10/2000 |
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) |
SURGICAL INSTRUMENT SYSTEMS (SIS), LTD |
Judy Gordon |
| K994421 |
02/23/2000 |
SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION |
SURGICAL NAVIGATION SPECIALISTS, INC. |
CAROL NAKAGAWA |
| K992461 |
02/22/2000 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K003015 |
12/15/2000 |
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD |
SURGICAL SPECIALTIES CORP. |
VIKKI M HOFFMAN |
| K000089 |
02/03/2000 |
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS |
SYNTHES (USA) |
BONNIE J SMITH |
| K992739 |
02/08/2000 |
CLICK'X |
SYNTHES SPINE |
JONATHAN M GILBERT |
| K993980 |
02/01/2000 |
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL |
SYVA CO. |
PAUL L ROGERS |
| K993981 |
02/01/2000 |
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL |
SYVA CO. |
PAUL L ROGERS |
| K002755 |
12/04/2000 |
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE |
T. KOROS SURGICAL INSTRUMENTS CORP. |
TIBOR KOROS |
| K993832 |
02/09/2000 |
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 |
TANDEM MEDICAL, INC. |
ALBERT MISAJON |
| K994024 |
02/03/2000 |
EXTENDED STRAIGHT ATTACHMENT |
TEAM TECHNOLOGIES, INC. |
BOB WALTON |
| K000102 |
02/08/2000 |
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 |
TECO DIAGNOSTICS |
DINDO CARRILLO |
| K994250 |
02/07/2000 |
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
TEKMEDIC (M) SDN BHD |
KOK-KEE HON |
| K990403 |
02/03/2000 |
TED 200T7 OXYGEN MONITOR |
TELEDYNE ELECTRONIC TECHNOLOGIES |
RAY KHAJAVI |
| K003547 |
12/21/2000 |
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K003545 |
12/21/2000 |
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K003371 |
12/21/2000 |
PUMP TUBING WITH X-COATING |
TERUMO CORP. |
GARRY A COURTNEY |
| K003265 |
12/22/2000 |
CLEANAIR/ CLEANWATER UNIT, MODEL 1600 |
TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY |
H.O. PIPKIN |
| K000152 |
02/29/2000 |
KIPPMED I.V. MANIFOLD |
THE KIPP GROUP |
GARY WERSCHMIDT |
| K991580 |
02/04/2000 |
ILM ENDOTRACHEAL TUBE |
THE LARYNGEAL MASK CO.,LTD. |
ROBERT L SHERIDAN |
| K002749 |
12/04/2000 |
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K993976 |
02/22/2000 |
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR |
THE PROMETHEUS GROUP |
RICHARD HORTON |
| K994383 |
02/04/2000 |
DOGBONE ACFS |
THEKEN SURGICAL |
LUKAS EISERMANN |
| K003183 |
12/08/2000 |
THERMAGE THERMACOOL II SYSTEM |
THERMAGE, INC. |
KEITH MULLOWNEY |
| K001927 |
12/18/2000 |
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME |
THORATEC LABORATORIES CORP. |
DONALD A MIDDLEBROOK |
| K992556 |
02/17/2000 |
PERMACOL |
TISSUE SCIENCE LABORATORIES, PLC |
ALLISON F WREN |
| K003005 |
12/08/2000 |
TISSUELINK BIPOLAR FORCEPS |
TISSUELINK MEDICAL, INC. |
ROBERTA L THOMPSON |
| K984565 |
02/16/2000 |
TMC-EASY-302 |
TMC MAGNETICS & MACHINERY CORP. |
SUSAN D GOLDSTEIN-FALK |
| K993917 |
02/02/2000 |
TOKUYAMA ONE-UP-BOND F |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K003728 |
12/20/2000 |
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM |
TORNIER |
DAVID W SCHLERF |
| K993803 |
02/06/2000 |
EXCELART WITH PIANISSIMO |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K993998 |
02/04/2000 |
NYLON |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994002 |
02/04/2000 |
PLAIN/CHROMIC CATGUT |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994000 |
02/04/2000 |
POLYESTER |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994001 |
02/09/2000 |
POLYGLYCOLIC ACID |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K993997 |
02/04/2000 |
POLYPROPYLENE |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K993999 |
02/04/2000 |
SILK |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K000572 |
02/24/2000 |
E.N.S.I. SYRINGE |
TRI-JECT INTL. CORP. |
PETER G LEMIN |
| K002308 |
12/20/2000 |
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K001634 |
12/21/2000 |
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 |
TZ MEDICAL, INC. |
BYRON ZAHLER |
| K000149 |
02/07/2000 |
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE |
U.S. BIOMATERIALS CORP. |
ALBERT FOSMOE |
| K993846 |
02/16/2000 |
ULTRASEAL XT PLUS |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K994261 |
02/02/2000 |
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K994078 |
12/04/2000 |
U1 HIP SYSTEM |
UNITED ORTHOPEDIC CORP. |
MELLEN LIU |
| K001895 |
12/08/2000 |
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ERIKA J MILLER |
| K993436 |
02/11/2000 |
CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
| DEN000002 |
02/09/2000 |
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE |
UROSURGE, INC. |
STEVEN J PREISS |
| K994345 |
02/14/2000 |
MAGNA 5000 PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K000002 |
02/23/2000 |
MAGNA 5000 PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K994054 |
02/14/2000 |
ISSA PHAROS |
VAMS TEC, D.O.O. |
DAVID W SCHLERF |
| K993872 |
02/16/2000 |
VANNA BATHING SYSTEM |
VANCARE, INC. |
JAMES A VANDERHEIDEN |
| K992751 |
02/16/2000 |
SOMAVISION |
VARIAN ASSOC., INC. |
LINDA S NASH |
| K993995 |
02/14/2000 |
VEIN ENTRY INDICATOR DEVICE (VEID) |
VASCULAR TECHNOLOGIES LTD. |
AHAVA STEIN |
| K001621 |
12/06/2000 |
DARDIK CAROTID SHUNT |
VASCUTECH, INC. |
TRENT G KAMKE |
| K992940 |
02/22/2000 |
LEMAITRE BALLOON CATHETER WITH IRRIGATION |
VASCUTECH, INC. |
TRENT G KAMKE |
| K003469 |
12/06/2000 |
EECP THERAPY SYSTEM, MODEL TS3 |
VASOMEDICAL, INC. |
THOMAS R VARRICCHIONE |
| K994176 |
02/08/2000 |
SUTRALON NYLON SUTURES |
VISIONARY MEDICAL SUPPLIES, INC. |
JONATHAN GREEN |
| K994177 |
02/08/2000 |
SUTRASILK SILK SUTURE |
VISIONARY MEDICAL SUPPLIES, INC. |
JONATHAN GREEN |
| K994324 |
02/23/2000 |
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
SHARON BRIGGS |
| K994318 |
02/23/2000 |
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
SHARON BRIGGS |
| K003230 |
12/27/2000 |
V SCORE WITH AUTO GATE MODEL TBD |
VITAL IMAGES, INC. |
ROBERT C SAMEC |
| K994044 |
02/25/2000 |
CLEEN-ABLE |
VITAL SIGNS, INC. |
ANTHONY MARTINO |
| K991412 |
02/04/2000 |
VITALOGRAPH MICRO |
VITALOGRAPH, INC. |
PHIL HEMES |
| K991345 |
02/18/2000 |
ASP-100, MODEL 2100 |
VITROLIFE SWEDEN AB |
EILER ANDERSON |
| K991351 |
02/25/2000 |
OVOIL-150, MODEL 5002 |
VITROLIFE SWEDEN AB |
EILER ANDERSON |
| K991346 |
02/24/2000 |
PH-100, MODEL 2104 |
VITROLIFE SWEDEN AB |
EILER ANDERSON |
| K003439 |
12/15/2000 |
VIVANT BREAST LESION LOCALIZATION DEVICE |
VIVANT MEDICAL, INC. |
GEORGE HERMANN |
| K003115 |
12/19/2000 |
ACTIS ADJUSTABLE CONSTRICTION LOOP |
VIVUS, INC. |
CAROL D KARP |
| K003092 |
12/18/2000 |
MODIFICATION TO VNUS CLOSURE SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
| K994304 |
02/07/2000 |
ARABESK FLOW |
VOCO GMBH |
EVAN DICK |
| K994268 |
02/03/2000 |
ARABESK TOP |
VOCO GMBH |
EVAN DICK |
| K000185 |
02/14/2000 |
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
| K000153 |
02/08/2000 |
ARTHRO-SURGIMAT-A103 |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
| DEN990008 |
02/15/2000 |
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 |
WALLAC, INC. |
CARROLL L MARTIN |
| K003337 |
12/21/2000 |
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 |
WECK CLOSURE SYSTEMS |
BRIAN YOUNG |
| K993903 |
02/14/2000 |
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
| K994061 |
02/14/2000 |
LOCON-T DISTAL RADIAL PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K003016 |
12/13/2000 |
PRO-FEMUR R |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K993958 |
02/14/2000 |
IDX-60 INTRAORAL X-RAY |
X-CEL X-RAY CORP. |
WILLIAM W MORRIS |
| K003568 |
12/27/2000 |
XISCAN 6000 IMAGING SYSTEM |
XITEC, INC. |
SHEILA M HEMEON-HEYER |
| K002969 |
12/08/2000 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 |
XLTEK |
DEBBIE DAVY |
| K994262 |
02/08/2000 |
FRONTAL SINUS TREPHINATION CANNULA |
XOMED, INC. |
MARTIN D SARGENT |
| K002395 |
12/11/2000 |
MODEL 30 CLASSIC PNEUMATONOMETER |
XOMED, INC. |
DIANA PRESTON |
| K002987 |
12/04/2000 |
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE |
XOMED, INC. |
MARTIN D SARGENT |
| K002893 |
12/04/2000 |
FLUOROLAB PLUS |
Z-KAT, INC. |
WILLIAM F TAPIA |
| K002971 |
12/15/2000 |
MTG - MINITUB HEATED STAGE SYSTEMS |
ZANDER MEDICAL SUPPLIES, INC. |
FRIEDEL MW ZANDER |
| K003118 |
12/20/2000 |
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 |
ZCV ,INC. |
JING ZHANG |
| K002481 |
12/07/2000 |
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 |
ZCV ,INC. |
JING ZHANG |
| K000363 |
02/18/2000 |
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K000362 |
02/18/2000 |
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K002960 |
12/11/2000 |
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 |
ZIMMER, INC. |
KAREN CAIN |
| K993036 |
02/28/2000 |
ZOLL M SERIES ETCO2 OPTION |
ZOLL MEDICAL CORP. |
PAUL DIAS |
