FDA 510(k) Decisions During December, 2000  

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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact