| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| 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 |
| 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 |
| 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 |
| K003739 |
12/27/2000 |
ALOKA SSD-4000 |
ALOKA CO., LTD. |
CHRISTOPER BOHL |
| K001282 |
12/15/2000 |
AIW WATER SYSTEM FOR HEMODIALYSIS |
AMERICAN INDUSTRIAL WATER |
JOE GREENING |
| K003769 |
12/22/2000 |
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| 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 |
| K003029 |
12/04/2000 |
INFUSOMAT P |
B. BRAUN MEDICAL, INC. |
GARY A GULTAS |
| 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 |
| 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 |
| 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 |
| 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 |
| K003363 |
12/15/2000 |
M2A 32MM TAPER SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K002449 |
12/22/2000 |
BIOTEQ I.V. (INTRAVENOUS) SET |
BIOTEQUE CORP. |
JENNIFER CHEN |
| K003770 |
12/15/2000 |
BIRD TBIRD LEGACY VENTILATOR |
BIRD PRODUCTS CORP. |
TOM GUTIERREZ |
| 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 |
| K002197 |
12/27/2000 |
CARTOUCH |
CARDIONICS, INC. |
JEFF MORGAN |
| 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 |
| K003455 |
12/06/2000 |
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K003071 |
12/13/2000 |
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
CIBA VISION CORPORATION |
TERRINA WILDER |
| 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 |
| 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 |
| K003716 |
12/20/2000 |
CONFORMANCE CHEMISTRY CONTROL C3 |
CONSOLIDATED TECHNOLOGY |
RUSTY SEWELL |
| 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 |
| K993641 |
12/14/2000 |
METALYZER, MODEL 2; METALYZER, MODEL 3 |
CORTEX BIOPHYSIK GMBH |
ART WARD |
| 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 |
| K003209 |
12/05/2000 |
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A |
DADE BEHRING, INC. |
CATHY P CRAFT |
| 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 |
| 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 |
| K002925 |
12/20/2000 |
COOLBLU CURING LIGHT |
DENTAL SYSTEMS.COM, INC. |
SHINOBU DOI |
| 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 |
| 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 |
| K002768 |
12/05/2000 |
ACAPELLA |
DHD HEALTHCARE CORP. |
LAWRENCE WEINSTEIN |
| K003372 |
12/26/2000 |
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP |
DIAGNOSTIC PRODUCTS CORP. |
EDWARDS M LEVINE |
| K002128 |
12/05/2000 |
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
MICHAEL (RUSTY) NICAR |
| 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 |
| K003067 |
12/13/2000 |
CALEO |
DRAGER MEDIZINTECHNIK GMBH |
JIM BRENNAN |
| 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 |
| K003452 |
12/07/2000 |
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D |
EP TECHNOLOGIES, INC. |
CHRISTINA ROWE |
| K000396 |
12/27/2000 |
APNOESCREEN PRO, ALPHA SCREEN PRO |
ERICH JAEGER, INC. |
LARRY MURDOCK |
| 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 |
| 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 |
| K003264 |
12/21/2000 |
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K003849 |
12/22/2000 |
GE ADVANCE NXI PET SYSTEM |
GE MEDICAL SYSTEMS, INC. |
D DUERSTELER |
| K002803 |
12/27/2000 |
THE O'NEIL STERILE FIELD URINARY CATHETER KIT |
GO MEDICAL INDUSTRIES PTY. LTD. |
GEORGE O'NEIL |
| 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 |
| 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 |
| K002923 |
12/18/2000 |
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| 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 |
| 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 |
| 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 |
| 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 |
| K002384 |
12/15/2000 |
M-XX OXYGEN SENSORS |
INTERNATIONAL BUSINESS STRATEGIES |
WILLIAM ROETTGER |
| K001211 |
12/04/2000 |
MODIFICATION TO INTRALASE 600C LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| 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 |
| 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 |
| K003327 |
12/05/2000 |
ALBUMIN |
JAS Diagnostics, Inc. |
David Johnston |
| K003247 |
12/14/2000 |
CREATININE |
JAS Diagnostics, Inc. |
David Johnston |
| 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 |
| K003228 |
12/14/2000 |
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A |
KATECHO, INC. |
WARREN R WALTERS |
| 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 |
| 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 |
| K001441 |
12/18/2000 |
SATURN BLOOD GLUCOSE MONITORING TEST STRIP |
LIFESCAN, INC. |
MARY ELLEN HOLDEN |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K003724 |
12/21/2000 |
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B |
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 |
| 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 |
| 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 |
| K002425 |
12/21/2000 |
MEDIADENT HDX/MMD HDX SP XRAY SENSOR |
MULTI MEDIA DENTAL SYSTEMS, INC. |
SCOTT MCLAUGHLIN |
| K003520 |
12/13/2000 |
NEXAN SYSTEM, MODEL NX-300 |
NEXAN LTD |
DAVID L WEST |
| K001465 |
12/05/2000 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
RICHARD D BLISS, JR. |
| 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 |
| 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 |
| 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 |
| 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 |
| K993406 |
12/18/2000 |
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 |
PERMOBIL A.B. |
BENGT PERSSON |
| 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 |
| K001499 |
12/27/2000 |
PHORMAX EAGLE SCANNER SYSTEM |
PHORMAX CORP. |
SHEILA W PICKERING |
| K992424 |
12/29/2000 |
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 |
PLASTIMED LABORATOIRE PHARMACEUTIQUE |
JEAN-DANIEL NURY |
| K994146 |
12/11/2000 |
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP |
PLUS ORTHOPEDICS |
DAVID W SCHLERF |
| K003277 |
12/21/2000 |
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 |
POWERMED, INC. |
MICHELE LUCEY |
| 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 |
| 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 |
| K001866 |
12/07/2000 |
TCM400 |
RADIOMETER MEDICAL A/S |
KRISTEN RONO |
| 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 |
| 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 |
| K003048 |
12/15/2000 |
ALL TERRAIN WHEELCHAIR (ATW) |
ROLL-ABILITY (PTY) LTD. |
VICTOR F MYBURGH |
| 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 |
| K003734 |
12/21/2000 |
SERUM PROTEIN SUBSTITUTE |
SAGE BIOPHARMA |
GRACE HOLLAND |
| K000249 |
12/11/2000 |
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 |
SCHAEFER WATER CENTERS |
MICHAEL J SCHAEFER |
| 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 |
| K002411 |
12/12/2000 |
SHENLING ACUPUNCTURE NEEDLES |
SHENLING MEDICAL DEVICE CO., LTD |
GEORGE SU |
| K002391 |
12/04/2000 |
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) |
SIAM SEMPERMED CORP. LTD. |
WILLIAM HARRIS |
| 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 |
| 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 |
| K002747 |
12/15/2000 |
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
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 |
| K002753 |
12/04/2000 |
SPARTAN A-10 |
SPARTAN ULTRASONICS, INC. |
ALDO E EAGLE |
| K002976 |
12/22/2000 |
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX |
ST. JUDE MEDICAL |
DEAN BRUHN-DING |
| 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 |
| K003660 |
12/12/2000 |
LEIBINGER NEURO CLIP SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| 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 |
| K003015 |
12/15/2000 |
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD |
SURGICAL SPECIALTIES CORP. |
VIKKI M HOFFMAN |
| K002755 |
12/04/2000 |
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE |
T. KOROS SURGICAL INSTRUMENTS CORP. |
TIBOR KOROS |
| 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 |
| K002749 |
12/04/2000 |
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| 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 |
| K003005 |
12/08/2000 |
TISSUELINK BIPOLAR FORCEPS |
TISSUELINK MEDICAL, INC. |
ROBERTA L THOMPSON |
| K003728 |
12/20/2000 |
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM |
TORNIER |
DAVID W SCHLERF |
| 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 |
| 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 |
| K001621 |
12/06/2000 |
DARDIK CAROTID SHUNT |
VASCUTECH, INC. |
TRENT G KAMKE |
| K003469 |
12/06/2000 |
EECP THERAPY SYSTEM, MODEL TS3 |
VASOMEDICAL, INC. |
THOMAS R VARRICCHIONE |
| K003230 |
12/27/2000 |
V SCORE WITH AUTO GATE MODEL TBD |
VITAL IMAGES, INC. |
ROBERT C SAMEC |
| 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 |
| 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 |
| K003016 |
12/13/2000 |
PRO-FEMUR R |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| 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 |
| 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 |
| K002960 |
12/11/2000 |
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 |
ZIMMER, INC. |
KAREN CAIN |
