FDA 510(k) Decisions During November, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
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
K052374 11/22/2005 RAPID PROGEAMMER 3.0 ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K051492 11/14/2005 AESKULISA ASCA A AESKU.INC STANLEY AMMONS
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
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
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
K052698 11/08/2005 MODIFICATION TO: AURORA AURORA IMAGING TECHNOLOGY, INC. MICHAEL A DOUGLAS
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
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
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
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
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
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
K052656 11/07/2005 VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K052255 11/23/2005 ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS BIOMET, INC. ALLISON K KOSKEY
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
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
K052213 11/02/2005 NAVIGATION SW HIP 3.1 ON CI BRAINLAB AG RAINER BIRKENBACH
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
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
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
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
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
K053155 11/23/2005 VIMPLANT CYBERMED, INC. SONG NAK CHOI
K052496 11/04/2005 PRIMECHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K052883 11/01/2005 CARDIOSERVER DATRIX LINDA GLUCKMAN
K053083 11/30/2005 DATRIX CARDIO WIFI ELECTROCARDIOGRAPH DATRIX LINDA GLUCKMAN
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
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
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
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
K052530 11/18/2005 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA GALIL MEDICAL LTD. JONATHAN S KAHN
K052253 11/02/2005 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS GAMBRO RENAL PRODUCTS FEI LAW
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
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
K052978 11/09/2005 GE 1.5T SIGNA HDE MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER
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
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
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
K053000 11/21/2005 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) HAEMONETICS CORP. GABRIEL J MURACA
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
K043007 11/07/2005 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 HYPHEN BIOMED OLA ANDERSON
K051401 11/30/2005 ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER I-FLOW CORP. SHANE NOEHRE
K051144 11/18/2005 ACETYLCHOLINE RECEPTOR AB (ARAB)RRA IBL-HAMBURG GMBH Gary Lehnus
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
K052505 11/04/2005 CALF IMPLANT, MODEL EC17-X IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K052504 11/04/2005 GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K053046 11/08/2005 ILUMA ORTHOCAT/DENTALCAT IMTEC CORP. J. BRAD VANCE
K052662 11/30/2005 ONE STEP FSH MENOPAUSAL TEST IND DIAGNOSTIC INC. JASON PENG
K052545 11/08/2005 INFINITT G3 PACS INFINITT CO., LTD. CARL ALLETTO
K052624 11/16/2005 INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE INION LTD. HANNA MARTTILA
K051821 11/25/2005 INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM INION LTD. HANNA MARTTILA
K052059 11/22/2005 IUI CATHETER, MODEL 9057 INNTEC, INC. Gary Syring
K052663 11/04/2005 INO THERAPEUTICS INOBLENDER, MODEL 10004 INO THERAPEUTICS FREDERICK MONTGOMERY
K052264 11/23/2005 QUANTA LITE CCP3 IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K051450 11/10/2005 EXTENDED MEASUREMENTS SYSTEM INOVISE MEDICAL, INC. STEVE C HESLER
K053045 11/21/2005 MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 INTEGRA LIFESCIENCES CORPORATION DONNA WALLACE
K052169 11/17/2005 IMC SURGICAL DRAPES INTERNATIONAL MEDSURG CONNECTION, INC. MANNY GUPTA
K052550 11/17/2005 IMC SURGICAL GOWNS INTL. MEDSURG CONNECTION, INC. MANNY GUPTA
K052791 11/04/2005 MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. STEPHANIE ROBINSON
K052704 11/03/2005 MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE INVIVO CORP. THOMAS E TYNES
K053017 11/16/2005 MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS INVIVO CORPORATION THOMAS SCHUBERT
K053030 11/07/2005 J. MORITA AZ ULTRASONIC SYSTEM J. MORITA USA, INC. HOWARD ROWE
K052561 11/23/2005 TERUMO MICRO TAPERED PEN NEEDLE KOFU FACTORY OF TERUMO CORP. BARBARA SMITH
K052095 11/03/2005 MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 KONICA MINOLTA MEDICAL & GRAPHIC, INC. MASAFUMI SAITO
K051998 11/03/2005 REGIUS MODEL 170 DIRECT DIGITIZER KONICA MINOLTA MEDICAL & GRAPHIC, INC. MASAFUMI SAITO
K053084 11/16/2005 SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM KONTRON MEDICAL SYSTEMS SAS LARRY WALKER
K050271 11/03/2005 KOWA GENESIS-D HAND-HELD RETINAL CAMERA KOWA CO. LTD. SATOHIKO TAKANISHI
K053026 11/10/2005 KOWA NONMYD 7, KOWA NONMYD A-D KOWA CO. LTD. SATOHIKO TAKANASHI
K051061 11/04/2005 KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. MEATHER VIELE
K043367 11/17/2005 GLAID OCULAR ELECTROPHYSIOLOGY DEVICE LACE ELECTRONICA S.R.L. IAN P GORDON
K052610 11/30/2005 IMAGE STAR II LAKESHORE TECHNOLOGIES INC. JACK RACE
K052980 11/30/2005 LIBERTY GLUCOSE CONTROL, MODEL 2120031 LIBERTY HEALTHCARE GROUP, INC. JOJN C GORMLEY
K053098 11/28/2005 OPTIUM DBM GEL AND PUTTY LIFENET DAVID KLEMENTOWSKI
K052526 11/15/2005 NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES LUMENIS, INC. KAREN L BAKER
K051034 11/22/2005 URYXXON 200 URINE ANALYZER MACHEREY-NAGEL GMBH & CO., KG. EDUARDO MARCH
K052851 11/18/2005 VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) MAKO SURGICAL CORP. WILLIAM F TAPIA
K052802 11/01/2005 MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE MANAN MEDICAL PRODUCTS, INC. NICOHL R WILDING
K053025 11/10/2005 JOSTRA HLM TUBING SET MAQUET CARDIOPULMONARY AG KATHLEEN JOHNSON
K051280 11/30/2005 MEDCOMP SPLIT CATH II MEDCOMP JEAN CALLOW
K051149 11/18/2005 MEDITECH MODEL ABPM-04 MEDITECH KFT. BENNY ARAZY
K053042 11/17/2005 MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE MEDRAD, INC. LISA A EWING
K052827 11/01/2005 MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS MEDRAD, INC. LISA A EWING
K051330 11/18/2005 UVBIOTEK MODELS 3200B AND 4000B MEDTEK LIGHTING CORPORATION ROBERT T WAGNER
K051082 11/08/2005 MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K052860 11/10/2005 CG FUTURE ANNULOPLASTY BAND MEDTRONIC HEART VALVES JULIE SHERMAN
K052431 11/29/2005 MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 MEDTRONIC MINIMED JODIE ROGERS
K052432 11/29/2005 MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 MEDTRONIC MINIMED JODIE ROGERS
K052524 11/22/2005 BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT MEDTRONIC PERFUSION SYSTEMS BRUCE BACKLUND
K052931 11/16/2005 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052413 11/17/2005 TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 MEDTRONIC VASCULAR JULIE GOODE
K052650 11/04/2005 PIONEER U601 SERIES ASPIRATOR MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K051836 11/21/2005 SKELITE RESORBABLE CEMENT RESTRICTOR MILLENIUM BIOLOGIX, INC. ROBERT SCHIFF
K053018 11/08/2005 POLY SILOXANE IMPRESSION MATERIAL MILLENNIUM DENTAL INTERNATIONAL, INC. JEANETTE SMITH
K052018 11/04/2005 MILTEX LIGATING CLIP MILTEX, INC. CHARLES WEAVER
K052702 11/21/2005 MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY MISONIX, INC. RONALD R MANNA
K051206 11/02/2005 Y2K2 ENTERNAL TUBE FLUID FILTER MOSS MEDICAL PRODUCTS GERALD MOSS
K052874 11/22/2005 SOPRANO HAIR REMOVAL DIODE LASER MSQ (M2) LTD. TATIANA EPSTEIN
K051963 11/23/2005 BE-CERTAIN PREGNANCY TEST NATUREPLEX, LLC VICTOR J SANTOS
K052186 11/10/2005 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P NELLCOR PURITAN BENNETT, INC. PATRICK GARVEY
K052474 11/10/2005 NIPRO HYPODERMIC NEEDLE NIPRO MEDICAL CORP. KAELYN B HADLEY
K052829 11/10/2005 WRISTOX MODEL 3100 PULSE OXIMETER NONIN MEDICAL, INC. LORI ROTH
K052987 11/08/2005 BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC NORAS RONTGEN-UND MEDIZINTECHNIK GMBH CARL ALLETTO
K052304 11/23/2005 SUPER PORCELAIN EX-3 PRESS NORITAKE CO., INC. IVAN J WASSERMAN
K052019 11/04/2005 NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE NORTH COAST MEDICAL, INC. TARHAN KAYIHAN
K052494 11/03/2005 NOVABONE-BIOACTIVE SYNTHETIC GRAFT NovaBone Products, LLC DAVID M GAISSER
K052228 11/09/2005 SMIT SLEEVE NUCLETRON CORPORATION LISA DIMMICK
K051886 11/14/2005 OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051647 11/08/2005 FORTADERM ANTIMICROBIAL WOUND DRESSING ORGANOGENESIS, INC. PATRICK BILBO
K052477 11/30/2005 DAMON 3 MODIFIED ORMCO CORP. COLLEEN BOSWELL
K042707 11/30/2005 GRAFTON PLUS DBM PASTE OSTEOTECH, INC. CHRISTOPHER TALBOT
K043048 11/23/2005 GRAFTON PLUS DBM PASTE OSTEOTECH, INC. CHRISTOPHER TALBOT
K051759 11/17/2005 FLEXI-LITE, MODEL FL-V1.2 PERFORMANCE HYPERBARICS SPENCER FELDMAN
K052961 11/18/2005 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K052801 11/02/2005 INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HAUKE SCHIK
K052377 11/17/2005 PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH EGON PFEIL
K052518 11/16/2005 PIEZOSURGERY PIEZOSURGERY SRL Maria E Donawa
K053053 11/16/2005 PACP SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN GILBERT
K052435 11/03/2005 PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS PNEUMRX, INC. ANNE C WORDEN
K052099 11/21/2005 NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ Polyganics BV JAN NIEUWENHUIS
K052256 11/10/2005 ANGIOJET XPEEDIOR 120 CATHETER POSSIS MEDICAL, INC. MARK STENOIEN
K052910 11/07/2005 POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K052903 11/09/2005 PEDIATRIC FEEDING TUBE PROMEDIC, INC. PAUL DRYDEN
K052709 11/08/2005 POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K051572 11/17/2005 KOKO LEGEND PULMONARY DATA SERVICES, INC. DONALD HENTON
K051161 11/22/2005 QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) QUEST DIAGNOSTICS, INC. JAMES BOURLAND
K052900 11/28/2005 QUILL NONABSORBABLE NYLON BARBED SUTURE QUILL MEDICAL, INC. LOIS V SMART
K052092 11/22/2005 RPS ADENO DETECTOR RAPID PATHOGEN SCREENING ROBERT SAMBURSKY
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