FDA 510(k) Decisions During January, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K043043 01/10/2005 HERMES BOND 2 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K041717 01/13/2005 POWERSTICK MALE LATEX CONDOMS A.P.DEAUVILLE, LLC. SCOTT L BAIER
K052638 11/07/2005 ABBOTT SPINE, INC. SPINNAKER SYSTEM ABBOTT SPINE, INC. LISA PETERSON
K051925 11/29/2005 CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN ACCESS BIO INCORPORATE YOUNG HO CHOI
K052335 11/23/2005 ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA ACCUTRON, INC. ROBERT N CLARK
K042168 01/14/2005 SYMPHONY VR RADIOPAQUE BONE CEMENT, MODELS CM-VR-1040, CM-VR-1020 ADVANCED BIOMATERIAL SYSTEMS, INC. MARIE MARLOW
K052374 11/22/2005 RAPID PROGEAMMER 3.0 ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K051492 11/14/2005 AESKULISA ASCA A AESKU.INC STANLEY AMMONS
K043487 01/28/2005 EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 AIZU OLYMPUS CO., LTD. LAURA STORMS-TYLER
K052703 11/10/2005 ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL ALDEN OPTICAL LABS., INC. CHARLES H CREIGHTON
K052603 11/16/2005 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K052414 11/16/2005 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K052201 11/10/2005 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. ELLEN A YARNALL
K052537 11/16/2005 CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 AMERICAN MEDICAL SALES, INC. CAROL M LIFLAND
K052647 11/09/2005 CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. AMERICAN SPINE CENTER, LTD. JAMES WHITE
K043550 01/27/2005 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 AMPLIFE CORPORATION SUSAN GOLDSTEIN-FALK
K043508 01/19/2005 DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS LLC LON D MCILVAIN
K042160 01/25/2005 SONOSURG TROCAR AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K042542 01/10/2005 CYTOVISION FOR CEP XY APPLIED IMAGING CORP. DIANE C DAY
K040497 01/26/2005 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. LOUISE M FOCHT
K052387 11/29/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC. ANN WATERHOUSE
K052607 11/07/2005 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS ARTHREX, INC. ANN WATERHOUSE
K052736 11/03/2005 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT ARTHREX, INC. ANN WATERHOUSE
K052667 11/25/2005 ARTSANA PISTON AND INSULIN SYRINGES ARTSANA S.P.A. LARA N SIMMONS
K051561 11/02/2005 ASAHI ANGIOGRAPHIC CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K052339 11/30/2005 ASAHI PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K043422 01/12/2005 ASAHI PTCA GUIDE WIRE, J SHAPE SERIES ASAHI INTECC CO., LTD. YOSHI TERAI
K052137 11/03/2005 ASCENSION MUH ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K052981 11/01/2005 BIS EEG MONITOR, MODEL BISX4 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K040625 01/18/2005 ATAD ARD CATHETER ATAD DEVELOPMENTS LTD. JACK ATAD
K043582 01/21/2005 OCEAN CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K052698 11/08/2005 MODIFICATION TO: AURORA AURORA IMAGING TECHNOLOGY, INC. MICHAEL A DOUGLAS
K042486 01/21/2005 PROCEDUR 10 SYRINGE DEVICE AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K042487 01/21/2005 PROCEDUR SF SAFETY SYRINGE DEVICE AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K052075 11/09/2005 PROCEDUR-10 AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K052541 11/03/2005 MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM AVANT MEDICAL SYSTEMS DANIEL KAMM
K043554 01/14/2005 ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 B-K MEDICAL A/S VILLY BRAENDER
K043524 01/13/2005 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 B-K MEDICAL A/S VILLY BRAENDER
K052393 11/09/2005 B. BRAUN MODIFIED BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052252 11/16/2005 CONTRAST MEDIA TRANSFER SETS B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052958 11/16/2005 COLOR NIO 2MP, E-2320 C BARCOVIEW LIEVEN DE WANDEL
K051672 11/23/2005 POWERPICC BARD ACCESS SYSTEMS, INC. LYNN M KIRCHOFF
K052578 11/25/2005 BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K050049 01/31/2005 DYNAFLO BYPASS GRAFT BARD PERIPHERAL VASCULAR, INC. GLENN NORTON
K052892 11/30/2005 SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K051722 11/18/2005 TRICOS T BAXTER HEALTHCARE CORP. BRIAN L BISHOP
K053082 11/30/2005 BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K043215 01/19/2005 FLOWCARE PLG CD4 REAGENT BECKMAN COULTER, INC. STAN SUGRUE
K052905 11/18/2005 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K052876 11/14/2005 TELITHROMYCIN 15UG BBL SENSI-DISC BECTON DICKINSON & CO. DAINELLE CLARK
K052853 11/17/2005 TIGECYCLINE 15UG BBL SENSI-DISC BECTON DICKINSON & CO. DAINELLE CLARK
K043389 01/21/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K052481 11/28/2005 BD VIPER SYSTEM BECTON, DICKINSON & CO. COLLEEN A KISTLER
K051914 11/03/2005 GENEROS 80, GENEROS 60 BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K051620 11/18/2005 MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES BETTER WATER, INC. MICHAEL CLINE
K040103 01/18/2005 SOUNDSKIN PHOTOTHERAPY SYSTEM BHC INTERNATIONAL, LTD. MICHAEL BREEN
K053126 11/30/2005 BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K052969 11/16/2005 SLENDERTONE GYMBODY, MODEL 512-01 BIO-MEDICAL RESEARCH, LTD. MICHAEL O'SULLIVAN
K052838 11/09/2005 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 BIO-RAD MARIA ZEBALLOS
K043208 01/07/2005 LIQUID ASSAYED MULTIQUAL CONTROL BIO-RAD MARIA ZEBALLOS
K043514 01/21/2005 ALLOGRAN-N-BONE VOID FILLER BIOCOMPOSITES LTD. STEPHEN BRATT
K043304 01/14/2005 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 BIOJECT MEDICAL TECHNOLOGIES INC. LAURENCE A POTTER
K052656 11/07/2005 VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K042321 01/28/2005 MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD BIOMET MANUFACTURING CORP. KACY ARNOLD
K052255 11/23/2005 ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS BIOMET, INC. ALLISON K KOSKEY
K042774 01/21/2005 MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS BIOMET, INC. PATRICIA SANDBORN BERES
K043537 01/14/2005 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K042678 01/03/2005 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K052596 11/15/2005 MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 BIOPRO, INC. DAVID MRAK
K042528 01/11/2005 INBODY, MODEL 3.0 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K052456 11/04/2005 MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED JASPER BENKE
K052280 11/07/2005 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM BOSTON SCIENTIFIC CORP. DEBBIE MCINTIRE
K053128 11/30/2005 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K040887 01/07/2005 B-R-A-H-M-S PCT LIA BRAHMS AKTIENGESELLSCHAFT MELISSA MAHALL
K052213 11/02/2005 NAVIGATION SW HIP 3.1 ON CI BRAINLAB AG RAINER BIRKENBACH
K042512 01/13/2005 VECTORVISION ACL BRAINLAB AG RAINER BIRKENBACH
K043502 01/14/2005 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC C.R. BARD, INC. LYNN M KIRCHOFF
K050800 11/23/2005 NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K052218 11/23/2005 CRONO FIVE AND CRONO PCA 50 CANE S.R.L. CARLO MUSSO
K052595 11/08/2005 CRC 15ULTRA CAPINTEC, INC. MARY ANNE DELL
K042254 01/13/2005 PMP4 SELFCHECK ECG CARD GUARD SCIENTIFIC SURVIVAL, LTD. NAAMA OREN
K040832 11/10/2005 C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 CARDICA, INC. SEVRINA CIUCCI
K051226 11/17/2005 AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER CARDINAL HEALTH SHARON NICHOLS
K052568 11/28/2005 ESTEEM STRETCHY VINYL GLOVE WITH COATING CARDINAL HEALTH AMY HOYD
K042849 01/13/2005 CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) CARDIOBIOMEDICAL CORPORATION JAMES F MONGIGARDO
K041630 01/31/2005 ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS CARDIOVASCULAR SYSTEMS INCORPORATED GARY SYRING
K052268 11/02/2005 VISUCAM PRO NM CARL ZEISS MEDITEC AG KENT W JONES
K052455 11/23/2005 IMPRESSIX CAVEX HOLLAND B.V. RICHARD WOORTMAN
K042129 01/27/2005 F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK CEDIC S.R.L. GIANCARLO GAGLIARDONI
K042641 01/07/2005 CHEMVIEW-10 CENOGENICS CORP. NITZA KATZ
K050609 11/09/2005 AQUADEX SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K053014 11/15/2005 POLY SILOXANE IMPRESSION MATERIAL CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. JEANETTE SMITH
K052679 11/18/2005 CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E CLINIQA CORPORATION CAROL RUGGIERO
K051799 11/02/2005 DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS COEUR, INC. DEBRA F MANNING
K053040 11/09/2005 PARACEM UNIVERSAL DC COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K043216 01/06/2005 CADSTREAM VERSION 4.0 CONFIRMA, INC. PATRICA A MILBANK
K052834 11/23/2005 MREYE EMBOLIZATION COIL COOK, INC. LISA M WEBB
K042691 11/08/2005 VERTEFIX VERTEBROPLASTY PROCEDURE SET COOK, INC. JENNIFER J BOSLEY
K042650 01/27/2005 BIOMOVE 3000 CURATRONIC, LTD. ARAVA HACOHEN
K043522 01/14/2005 ISSYS PEDICLE SCREW SYSTEM CUSTOM SPINE, INC. DEBBIE IAMPIETRO
K050069 01/31/2005 CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K053155 11/23/2005 VIMPLANT CYBERMED, INC. SONG NAK CHOI
K043326 01/26/2005 BEWELL, MODEL SC 20 CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN LAN
K043429 01/12/2005 CYNERGY LASER CYNOSURE, INC. GEORGE CHO
K043546 01/18/2005 DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE DADE BEHRING, INC. STANLEY GORAK
K043028 01/07/2005 EMIT II PLUS ECSTASY ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K042814 01/06/2005 READMYHEART DAILYCARE BIOMEDICAL INC JENNIFER REICH
K052496 11/04/2005 PRIMECHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K042315 01/21/2005 CEREBRAL STATE MONITOR - CSM DANMETER A/S HANNE NIELSEN
K052883 11/01/2005 CARDIOSERVER DATRIX LINDA GLUCKMAN
K053083 11/30/2005 DATRIX CARDIO WIFI ELECTROCARDIOGRAPH DATRIX LINDA GLUCKMAN
K042745 01/19/2005 LIFESCREEN APNEA DEL MAR REYNOLDS MEDICAL, INC. GEORGE MYERS
K043264 01/26/2005 LDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K043136 01/06/2005 ELITY 70 X-RAY DENTAL X-RAY E.U. GEORGE ECHEVERRI
K052370 11/01/2005 CP BRACKET SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K053010 11/22/2005 VISTADENT AT COMPLETE, MODEL 3.1 DENTSPLY INTL., INC. HELEN LEWIS
K051711 11/15/2005 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS DENVER BIOMEDICAL, INC. NANCY SAUER
K053002 11/22/2005 DEPUY CMW 1 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K053003 11/22/2005 DEPUY CMW 1, 2 AND 3 BONE CEMENTS DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K043113 01/21/2005 TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE DEPUY ORTHOPAEDICS, INC. CLAUDIA S SWANSON
K043530 01/25/2005 DVI CURING LIGHT DESIGNS FOR VISION, INC. MARY MCNAMARA-CULLINANE
K042330 01/07/2005 ACETAMINOPHEN-SL ASSAY DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K051757 11/10/2005 CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 DIAGNOSTIC CHEMICALS LTD. PENNY WHITE
K051658 11/16/2005 INFINITY ALPHA DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K043549 01/21/2005 INFINITY GATEWAY SUITE, VF4 DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K053114 11/15/2005 SILVERFIL DUNIA PERWIRA MANUFACTURING SDN. BHD. NARESH SANCHANA
K052314 11/09/2005 DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE DYNAREX CORP. JAMES HURLMAN
K043047 01/07/2005 DYNATRON IBOX IONTOPHORESIS DEVICE DYNATRONICS CORP. RONALD J HATCH
K043065 01/26/2005 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P EDWARDS LIFESCIENCES, LLC. JASON SMITH
K043309 01/26/2005 GEODESIC PHOTOGRAMMETRY SYSTEM ELECTRICAL GEODESICS, INCORPORATED LINDA J BOVARD
K042794 01/31/2005 BEAM MODULATOR, MODEL 4513 332 8000 ELEKTA LTD. PETER STEGAGNO
K050035 01/25/2005 ELEKTA NEUROMAG WITH MAXWELL FILTER ELEKTA NEUROMAG OY LOUISE LINDBLAD
K041920 01/21/2005 INFINITY PLUS ELECTROTHERAPY SYSTEM EMPI MARY MCNAMARA-CULLINANE
K042870 01/11/2005 ENDO TWINN ENDO TWINN B.V. F.M. VERHOEVEN
K052938 11/17/2005 CR-PRO ERADLINK, INC. ALBERT KOUBA
K052401 11/28/2005 GYNECARE TVT SECUR SYSTEM ETHICON, INC. PATRICIA M HOJNOSKI
K050571 11/02/2005 ABSOLUTE AMERICA EURODENT S.P.A. AVI POLITI
K051455 11/23/2005 WIESLAB CAP MPO-ANCA EURODIAGNOSTICA WILLIAM L BOTELER JR.
K051458 11/22/2005 WIESLAB CAP PR-3 ANCA EURODIAGNOSTICA WILLIAM L BOTELER JR.
K052909 11/01/2005 EVENFLO ELAN BREAST PUMP EVENFLO COMPANY, INC. THOMAS A SPARNO
K050398 11/18/2005 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC. LISA SIMPSON
K034026 01/12/2005 RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS FISHER & PAYKEL HEALTHCARE, LTD. ADELE BINDON
K042924 01/24/2005 ARCHITECT STAT MYO IMMUNOASSAY FISHER DIAGNOSTICS JOSEFINA INFANTAS
K042217 01/12/2005 FLOWMEDIC, MODEL 220 FLOWMEDIC (ISRAEL) LTD JONATHAN KAHAN
K041824 01/07/2005 X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM FUTURE MEDICAL SYSTEMS, SA PATRICK JANIN
K052530 11/18/2005 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA GALIL MEDICAL LTD. JONATHAN S KAHN
K042938 01/06/2005 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K052253 11/02/2005 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS GAMBRO RENAL PRODUCTS FEI LAW
K043471 01/27/2005 FUSION FAST GC AMERICA, INC. TERRY L JORITZ
K043301 01/25/2005 GC TION GINGIVAL PROTECTOR GC AMERICA, INC. TERRY JORITZ
K052995 11/08/2005 ADVANTAGE WORKSTATION 4.3. GE HEALTHCARE LARRY A KROGER
K052977 11/22/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052880 11/02/2005 DATEX-OHMEDA S/5 INTERFACE MODULE E-INT GE HEALTHCARE JOEL C KENT
K052756 11/01/2005 DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM GE HEALTHCARE JOEL KENT
K043262 01/12/2005 GE SIGNA EXCITE MR SURGICAL OPTION GE HEALTHCARE LARRY A KROGER
K051734 11/23/2005 GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 GE HEALTHCARE TECHNOLOGIES RAJ KASBEKAR
K043207 11/04/2005 OZONE GENERATOR GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES CHARLENE NASH
K053009 11/17/2005 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K043415 01/21/2005 CENTRICITY PACS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CAROL ALLOIAN
K052978 11/09/2005 GE 1.5T SIGNA HDE MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K042602 01/13/2005 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING GE MEDICAL SYSTEMS, LLC MARK M STAUFFER
K043072 01/27/2005 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS GEN-PROBE, INC. ALAN MADERAZO
K052897 11/08/2005 GE DEFINIUM AMX 700, MODEL AMX 700 GENERAL ELECTRIC MEDICAL SYSTEMS MARK STAUFFER
K052899 11/17/2005 ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC GENESEE BIOMEDICAL, INC. JOHN T.M. WRIGHT
K052565 11/17/2005 ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF GENESEE BIOMEDICAL, INC. JOHN T. M. WRIGHT
K043346 01/31/2005 GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 GENESIS MEDICAL L.L.C. PERRY GEREMAKIS
K052745 11/23/2005 ASSISTO ARM SYSTEMS GEOMED MEDIZIN-TECHNIK GMBH & CO. ANGELIKA SCHERP
K052605 11/10/2005 EXTERNAL FIXATION GEXFIX USA INC. LUCIO IMPROTA
K050473 11/14/2005 RBK PATELLA FEMORAL KNEE GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. CARL KNOBLOCH
K042898 01/18/2005 PANTHERA N POWDER FREE BLACK NITRILE GLOVES GLOVCO (M) SDN. BHD. TAN PENG HOCK
K050027 01/27/2005 LAPAROCISION SCOPE CONTROLLER SYSTEM GMP/COMPANIES, INC. RALPH JUGO
K050024 11/17/2005 ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS GUANGZHOU WONDFO BIOTECH CO., LTD. HOWARD K MANN
K050550 11/09/2005 GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR GYRUS MEDICAL, INC. MARK JENSEN
K043127 01/04/2005 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. GABRIEL J MURACA
K053000 11/21/2005 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) HAEMONETICS CORP. GABRIEL J MURACA
K043437 01/12/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET HEALTH & LIFE CO., LTD. PAUL HUNG
K043504 01/28/2005 PALAIMPACT HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043295 01/05/2005 VERSYO.DIRECT HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043376 01/10/2005 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR HOME HEALTH TECHNOLOGY CO., LTD. KE-MIN JEN
K052722 11/02/2005 LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS HOSPIRA, INC. THOMAS KOZMA
K053038 11/22/2005 HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K042993 01/12/2005 TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K043007 11/07/2005 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 HYPHEN BIOMED OLA ANDERSON
K043456 01/11/2005 MODIFICATION TO SOAKER CATHETER I-FLOW CORP. SHANE NOEHRE
K051401 11/30/2005 ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER I-FLOW CORP. SHANE NOEHRE
K042578 01/25/2005 I-PROMOTIONS CONTACT LENS CASE I-PROMOTIONS, INC. CHARLOTTE SLANKARD
K051144 11/18/2005 ACETYLCHOLINE RECEPTOR AB (ARAB)RRA IBL-HAMBURG GMBH GARY LEHNUS
K043336 01/21/2005 OPTISTRAND, MODEL 1032S IBT SA RUTH FEICHT
K051713 11/18/2005 JBAIDS ANTHRAC DETECTION SYSTEM IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K052618 11/17/2005 IMAGECAST PACS IDX SYSTEMS CORP. ROSINA ROBINSON
K051578 11/18/2005 IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS IMMUNALYSIS CORPORATION MICHAEL VINCENT
K042864 01/06/2005 IMPLANT SCIENCES CORP, MODEL HDR-4140 IMPLANT SCIENCES CORP. JOHN J MUNRO
K052505 11/04/2005 CALF IMPLANT, MODEL EC17-X IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
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