FDA 510(k) Applications Received During November, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K043189 11/24/2004 SONALIS, MODEL 2000 3G ULTRASOUND, INC. PAUL SCHNEIDER
K043015 11/02/2004 3L SURGICAL DRAPES 3L MEDICAL PRODUCTS CO., LTD. GEORGE SU
K043097 11/09/2004 3VISEON 3MENSIO MEDICAL IMAGING BV CARL ALLETTO
K042967 11/12/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 A & D ENGINEERING, INC. JERRY WANG
K043293 11/29/2004 MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U ACRORAD CO., LTD. T. WHIT ATHEY
K043079 11/09/2004 BICONTACT HIP SYSTEM WITH U-CAP AESCULAP KATHY A RACOSKY
K043041 11/09/2004 AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) AESCULAP, INC. MATTHEW M HULL
DEN040012 11/03/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. ROBERT LIPSHUTZ
K043085 11/08/2004 MODIFICATION TO: PNEUTON VENTILATOR AIRON CORPORATION ERIC GJERDE
K043299 11/30/2004 MEDLEY PCA MODULE, MODEL 8120 ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K043126 11/12/2004 ASSIST HEADER CLEANER ALCAVIS INTERNATIONAL, INC. GARY J MISHKIN
K043148 11/16/2004 ALL FLOW PULMONARY FUNCTION FILTER ALLIANCE TECH MEDICAL, INC. KEITH LOWREY
K043196 11/18/2004 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K042972 11/08/2004 XP TECHNOLOGY ULTRASONIC SCALER AMERICAN EAGLE INSTRUMENTS, INC. TOM THOMPSON
K043025 11/03/2004 SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 ANALOGIC CORP. DONALD J SHERRATT
K043191 11/17/2004 REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH ANGIOLOGICA B. M. SRL ROBERTO MANCA
K043123 11/12/2004 APEX MODULAR HA HIP STEM APEX SURGICAL, LLC. EDWARD J CHEAL
K043027 11/03/2004 MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 APPLIED MEDICAL TECHNOLOGY, INC. DEREK WILLIAMS
K043176 11/16/2004 ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM ARC SURGICAL LLC. ED BOEHMER
K043284 11/26/2004 ENDOASSIST ARMSTRONG HEALTHCARE LIMITED PATRICK A FINLAY
K043145 11/15/2004 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B ARTHREX, INC. SALLY FOUST
K043248 11/23/2004 TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS ARTHREX, INC. SALLY FOUST
K043138 11/12/2004 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 ATOS MEDICAL AB EDDY ABERG
K043249 11/23/2004 ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K043140 11/15/2004 EXPRESS AND OASIS CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K043228 11/22/2004 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS BAYER HEALTHCARE, LLC CAROL BIANCA
K043158 11/15/2004 ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC GEORGE M TANCOS
K043215 11/19/2004 FLOWCARE PLG CD4 REAGENT BECKMAN COULTER, INC. STAN SUGRUE
K043117 11/10/2004 BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K043208 11/19/2004 LIQUID ASSAYED MULTIQUAL CONTROL BIO-RAD MARIA ZEBALLOS
K043108 11/09/2004 LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES, INC. SUZANNE S PARSONS
K043067 11/08/2004 ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 BIOARRAY SOLUTIONS LTD KEVIN WYCKOFF
K043005 11/01/2004 MODIFICATION TO MBCP BIOMATLANTE MYRIAM VINCENT
K043230 11/22/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K043237 11/22/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN BIOMERIEUX, INC. JOLYN TENLLADO
K043100 11/09/2004 BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS BIOMET, INC. GARY BAKER
K043280 11/26/2004 MIMIX MP BONE VOID FILLER BIOMET, INC. KACY ARNOLD
K042999 11/01/2004 CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 BIOSENSE WEBSTER, INC. MARK O'DONNELL
K042998 11/01/2004 REFSTAR RMT EXTERNAL REFERENCE PATCH BIOSENSE WEBSTER, INC. MARK O'DONNELL
K043242 11/23/2004 TRIAGE TOX DRUG SCREEN BIOSITE INCORPORATED JEFFREY R DAHLEN
K043038 11/04/2004 BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML BIOTOP TECHNOLOGY CO., LTD. MARK LIEN
K043168 11/16/2004 BISCOVER LV BISCO, INC. BENJAMIN LICHTENWALNER
K043193 11/18/2004 BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. BARD, INC. FRANCES E HARRISON
K043246 11/23/2004 BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS C.R. BARD, INC. JOHN C KNORPP
K042949 11/01/2004 PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) C.R. BARD, INC. JOHN C KNORPP
K043251 11/23/2004 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B CANDELA CORP. LORRAINE CALZETTA
K043070 11/08/2004 LIQUID STABLE HBA1C CONTROL CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K043162 11/16/2004 PMP4 OXY PRO CARD GUARD SCIENTIFIC SURVIVAL, LTD. BORIS ARADOVSKY
K043096 11/09/2004 COMMANDER II CARDIOCOM CONSTANCE G BUNDY
K043222 11/22/2004 VISCUCAM C DIGITAL CAMERA CARL ZEISS MEDITEC AG R. MICHAEL CROMPTON
K043133 11/12/2004 AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR CEREMED, INC. TADEUSZ WELLISZ
K043034 11/03/2004 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS COLLAGEN MATRIX, INC. PEGGY HANSEN
K043216 11/22/2004 CADSTREAM VERSION 4.0 CONFIRMA, INC. PATRICA A MILBANK
K043296 11/29/2004 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING COVALON TECHNOLOGIES, INC. PAUL L GUILBAUD
K042955 11/19/2004 CUTICOVER SKIN BARRIER DEVICE D & D HOLDINGS, LLC MARK CITRON
K043028 11/03/2004 EMIT II PLUS ECSTASY ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K043255 11/26/2004 ELLIPSE LIGHT SPT DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K043276 11/26/2004 DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE DATEX-OHMEDA JOEL KENT
K043120 11/12/2004 MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER DATEX-OHMEDA, INC. JOEL KENT
K043136 11/12/2004 ELITY 70 X-RAY DENTAL X-RAY E.U. GEORGE ECHEVERRI
K042931 11/03/2004 TUF LINK SILICONE RELINER DENTATUS USA, LTD. THOMAS MURPHY
K042965 11/02/2004 TOMAS PIN DENTAURUM, INC. THOMAS LIETZ
K043247 11/23/2004 DUCERA ALLCERAM DENTSPLY INTL. HELEN LEWIS
K043298 11/30/2004 BLUE ORTHOCORD SUTURE DEPUY MITEK RUTH C FORSTADT
K042992 11/01/2004 CORAIL AMT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. NANCY S FRIDDLE
K043223 11/22/2004 DEPUY CAS KNEE INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. RANDA FRANKLIN
K043113 11/10/2004 TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE DEPUY ORTHOPAEDICS, INC. CLAUDIA S SWANSON
K043058 11/05/2004 PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY, INC. NATALIE HECK
K043000 11/01/2004 MODIFICATION TO D-TRONPLUS DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K043235 11/22/2004 DRAGON HEART I.V. SET DRAGON HEART MEDICAL DEVICES CO., LTD. JINA YU
K043164 11/16/2004 PANALIGHT-BLU, MODEL 4175 DUSA PHARMACEUTICALS, INC. SCOTT LUNDAHL
K043047 11/04/2004 DYNATRON IBOX IONTOPHORESIS DEVICE DYNATRONICS CORP. RONALD J HATCH
K043103 11/09/2004 VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 EDWARDS LIFESCIENCES, LLC. PAULA A TORRIANNI
K043065 11/05/2004 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P EDWARDS LIFESCIENCES, LLC. JASON SMITH
K043233 11/22/2004 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL EFRATGO, LTD. HI TECH BIO-SURGICAL GEORGE J HATTUB
K043269 11/26/2004 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K043068 11/08/2004 DIFOTI USB 2.0 SYSTEM ELECTRO-OPTICAL SCIENCES, INC. MICHAEL GREENEBAUM
K043257 11/26/2004 REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM EP TECHNOLOGIES, INC. TODD G BRILL
K043245 11/23/2004 EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. JENNIFER REICH
K043055 11/05/2004 TERRAQUANT MQ2000 LASER THERAPY DEVICE ESCADA INTERNATIONAL, INC. MARY MCNAMARA-CULLINANE
K043032 11/03/2004 DEALIGHT IPL EUROPRO, INC. GREG KENNEBECK
K043243 11/23/2004 PRIMUS STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K043149 11/15/2004 FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) FIRSTLINE, LLC. COLETTE PERCHES
K043244 11/23/2004 FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K043262 11/24/2004 GE SIGNA EXCITE MR SURGICAL OPTION GE HEALTHCARE LARRY A KROGER
K043207 11/19/2004 OZONE GENERATOR GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES CHARLENE NASH
K043076 11/08/2004 GE OEC FLUOROSTAR GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K043072 11/08/2004 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS GEN-PROBE, INC. ALAN MADERAZO
K043144 11/15/2004 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE GEN-PROBE, INC. ALAN MADERAZO
K043224 11/22/2004 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. ALAN MADERAZO
K043112 11/10/2004 GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K043035 11/03/2004 SEPRAGEL ENT BIORESORBABLE PACKING/STENT GENZYME CORPORATION BARBARA PIZZA
K043098 11/09/2004 GERBER DOUBLE ELECTRIC BREAST PUMP GERBER PRODUCTS CO. RANGA RANGANATHAN
K043033 11/03/2004 GLOBAL TREASURES FLUID FILLED TEETHER GLOBAL TREASURE INDUSTRIES LTD. FRAN WHITE
K043178 11/17/2004 GRANTALDER RHAPSODY ACCESS PORT AND CATHETER GRANTADLER CORPORTATION MICHAEL LOITERMAN
K043127 11/12/2004 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. GABRIEL J MURACA
K043170 11/16/2004 BOSWORTH BOND HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K043261 11/24/2004 HARVEST GRAFT DELIVERY SYRINGE HARVEST TECHNOLOGIES, CORP. JACK BONASERA
K043186 11/17/2004 H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM HEALTH & LIFE CO., LTD. PAUL HUNG
K043050 11/22/2004 HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON, INC. JOHN W MORGAN
K043239 11/23/2004 HEALTHSTAR ELITE HILL LABORATORIES CO. HOWARD A HILL
K043199 11/18/2004 SURGICAL FACE MASK HONG YA NON-WOVEN PRODUCTS CO., LTD. JAMES CHU
K043256 11/24/2004 HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 HOSPIRA, INC. PATRICIA MELERSKI
K043069 11/08/2004 HOVEROUND E100 POWER CHAIR HOVEROUND CORP. TONY DIGIOVANNI
K042993 11/01/2004 TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K043007 11/01/2004 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 HYPHEN BIOMED OLA ANDERSON
K043091 11/09/2004 NAVIGUS NEXDRIVE, MODEL MI-3000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K043226 11/22/2004 ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 IMTEC CORP. J. BRAD VANCE
K043142 11/15/2004 INION OTPS BIODEGRADABLE MINI PLATING SYSTEM INION LTD. HANNA MARTTILA
K043271 11/26/2004 R2-MRI ANALYSIS SYSTEM INNER VISION BIOMETRICS PTY LTD JANET PREUSS
K043190 11/17/2004 SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. HOWARD HOLSTEIN
K043074 11/08/2004 LIBERTY SYSTEM INOVISE MEDICAL, INC. STEVE HESLER
K043184 11/17/2004 HEMOSIL RECOMBIPLASTIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K043219 11/26/2004 AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS INTERACOUSTICS AS DANIEL EGGAN
K043229 11/22/2004 MODIFICATION TO ALTIUS OCT SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K043153 11/15/2004 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K043288 11/29/2004 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. USHA KREADEN
K043221 11/22/2004 WILLI GELLER CREATION CP PORCELAIN JENSEN INDUSTRIES, INC. GARY PHELPS
K043201 11/18/2004 WILLI GELLER CREATION ZI PORCELAIN JENSEN INDUSTRIES, INC. GARY PHELPS
K043009 11/01/2004 BRAINET KIT JORDAN NEUROSCIENCE, INC. ANNE PERRY
K043272 11/26/2004 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP KENDALL JIM WELSH
K043259 11/24/2004 BIOBLANKET SURGICAL MESH KENSEY NASH CORP. DEBORAH RACIOPPI
K043114 11/10/2004 KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE KIMBERLY-CLARK CORP. S. MCMILLAN
K043213 11/19/2004 KOWA VX-10 KOWA CO. LTD. RICHARD N PHILLIPS
K043177 11/22/2004 CLEAFIL DC CORE AUTOMIX KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K043094 11/15/2004 EASYSPINE SYSTEM LDR SPINE USA BRIAN BURKINSHAW
K043023 11/03/2004 PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 LEMAITRE VASCULAR, INC. SABA MODJARRAD
K043197 11/18/2004 ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. MARY ELLEN HOLDEN
K043106 11/09/2004 PINN-ACL CROSSPIN LINVATEC CORP. ELIZABETH M PAUL
K043173 11/16/2004 Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES LUMENIS, LTD. MARTHA MURARI
K043146 11/15/2004 HORIZON MEDICAL IMAGING MCKESSON MEDICAL IMAGING COMPANY ROBERT MACNEIL
K043292 11/29/2004 HEMOCATH MED-CONDUIT, INC. ROBERT W CUNNINGHAM
K043132 11/12/2004 UNIVERSAL XACTTRACE MEDCARE FLAGA KOLBRUN E OTTOSDOTTIR
K043134 11/12/2004 METRX WORKSTATION MEDICAL METRX SOLUTIONS, INC. PATSY J TRISLER
K043297 11/29/2004 MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM MEDICON, E.G. ANGELIKA SCHERP
K042974 11/10/2004 MEDICON VIPAIR HIGH SPEED SYSTEM MEDICON, E.G. JOACHIM SCHMID
K043017 11/02/2004 PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K043179 11/17/2004 SELECT 3D ARTERIAL CANNULA MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K043020 11/03/2004 GLAXY 3.2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043053 11/05/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043151 11/15/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043088 11/08/2004 MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES TINA DREILING
K043080 11/08/2004 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC VASCULAR BRUCE BACKLUND
K043287 11/29/2004 PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 MICRO MEDICAL DEVICES, INC. RAFI ISRAEL
K043110 11/10/2004 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K043013 11/08/2004 MILTEX LAPAROSCOPIC INSTRUMENTS MILTEX, INC. CHARLES WEAVER
K043231 11/30/2004 PROOF POSITIVE ELECTRONIC PREGNANCY TEST MIZUHO USA, INC. BENEDICT ZIN
K043036 11/05/2004 NON-STICK ELECTRODE MODERN MEDICAL EQUIPMENT MFG., LTD. ROBERT STILLMAN
K043183 11/17/2004 EPI-K MORIA S.A. ELANIE RENAUD-SAMIRI
K043010 11/08/2004 HOLTER RECORDER H3+ MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K043156 11/22/2004 D-CARIE, MODEL N121-M1 NEKS TECHNOLOGIES, INC. CHARLES H KYPER
K043195 11/18/2004 NEO IMPLANT SYSTEM NEOSS LTD RUSSELL PAGANO
K043274 11/26/2004 NEUROMONICS TINNITUS TREATMENT NEUROMONICS PTY LTD BEN MCSWEENEY
K043046 11/05/2004 COOLTOUCH, MODEL CT3S NEW STAR LASERS, INC. DONALD V JOHNSON
K043115 11/10/2004 LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K043042 11/04/2004 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 NOBEL BIOCARE AB ELIZABETH J MASON
K043202 11/18/2004 OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 OLYMPUS AMERICA, INC. BEV HARDING
K043128 11/12/2004 OLYMPUS ENDOARM OLYMPUS CORPORATION TINA STEFFANIE-OAK
K043275 11/26/2004 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K043018 11/02/2004 OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 OMRON HEALTHCARE, INC. LARRY LEPLEY
K043060 11/15/2004 OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 OMRON HEALTHCARE, INC. LARRY LEPLEY
K043254 11/24/2004 PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH ONSET MEDICAL CORPORATION ALBERT REGO
K042885 11/18/2004 OCT-OPTHALMOSCOPE OPHTHALMIC TECHNOLOGIES, INC. GEORGE MYERS
K043129 11/15/2004 PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) OPTI-CENTRE LABORATORIES BONNIE TSYMBAL
K043125 11/12/2004 ORION DIAGNOSTICA UNIQ PINP RIA ORION DIAGNOSTICA OY ANNIKKA RANTAMA
K043172 11/16/2004 TRUGRAFT BGS SYRINGE, MODEL 600-041 OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER
K043048 11/04/2004 GRAFTON PLUS DBM PASTE OSTEOTECH, INC. CHRISTOPHER TALBOT
K043209 11/19/2004 VIAGRAF DBM PASTE OSTEOTECH, INC. CHRISTOPHER TALBOT
K043063 11/05/2004 OXYBAND WOUND DRESSING OXYBAND TECHNOLOGIES, INC. MAUREEN O'CONNELL
K043130 11/12/2004 MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS PAJUNK GMBH BURK A BRANDT
K043167 11/16/2004 PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X PHAMATECH INC. CARL MONGIOVI
K043051 11/08/2004 QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 PHAMATECH INC. CARL MONGIOVI
K043147 11/15/2004 ACHIEVA FAMILY PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN T HARMER
K043090 11/08/2004 EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS PHONIC EAR, INC. TODD BISSEY
K043066 11/08/2004 PIONEER ANTERIOR CERVICAL PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K043206 11/19/2004 PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K043104 11/09/2004 KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 PRACTICEWORKS, INC. DANIEL HOEFER
K042991 11/08/2004 I-NEB AAD SYSTEM PROFILE THERAPEUTICS PLC BARBARA CAMPBELL
K043092 11/15/2004 PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 PROGENY, INC. ALAN KREMA
K043188 11/26/2004 ALCOHAWK PRECISION Q3 INNOVATIONS, LLC DANIEL KAMM
K043236 11/22/2004 FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA QUANTEL MEDICAL ROGER W BARNES
K043174 11/24/2004 STEALTH FUSION SYSTEM, MODEL RR 1000 R&R MEDICAL, INC. JD WEBB
K043218 11/22/2004 ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX RADIOMETER MEDICAL APS LENE MEINECHE MARNAES
K043143 11/15/2004 SAFEPICO RADIOMETER MEDICAL APS LENE MEINECHE MARNAES
K043003 11/01/2004 TCM40 MONITORING SYSTEM RADIOMETER MEDICAL APS PIERRE PELLETIER
K043267 11/26/2004 POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 RANDOX LABORATORIES, LTD. P. ARMSTRONG
K043071 11/08/2004 RANDOX PHENCYCLIDINE ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K043266 11/26/2004 RANDOX URINE CONTROLS RANDOX LABORATORIES, LTD. P. ARMSTRONG
K043268 11/26/2004 SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 RANDOX LABORATORIES, LTD. P ARMSTRONG
K043006 11/02/2004 MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 RESPIRONICS, INC. ZITA A YURKO
K043175 11/16/2004 ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043211 11/19/2004 ONLINE DAT BARBITURATES PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K043305 11/30/2004 ONLINE DAT PHENCYCLIDINE PLUS ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K043303 11/30/2004 ONLINE DAT PROPOXYPHENE PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K043095 11/09/2004 ROCHE DIAGNOSTICS ELECSYS AFP CALSET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043001 11/01/2004 MX POLYAXIAL PEDICLE SCREW SCIENT'X J.D. WEBB
K043232 11/22/2004 UCR SPINAL SYSTEM SEASPINE DIANA SMITH
K043002 11/01/2004 SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR SEDECAL S.A. DANIEL KAMM
K043031 11/09/2004 SERIM DIALYSATE MONITOR TEST STRIP SERIM RESEARCH CORP. PATRICIA A RUPCHOCK
K043204 11/18/2004 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP SGARLATO LABORATORIES, INC. MICHAEL MCDOUGALL
K043014 11/02/2004 POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS) SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD. JAMES CHU
K043122 11/12/2004 SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY SIEMENS AG GEORGE SCOTT
K043030 11/03/2004 MAGNETOM C! MR SYSTEM SIEMENS MEDICAL SOLUTIONS NEALIE HARTMAN
K043087 11/08/2004 SOMATOM CARE CONTRAST CT SIEMENS MEDICAL SOLUTIONS USA, INC. DEBBIE PEACOCK
K043086 11/08/2004 SOMATOM RESPIRATORY GATING SIEMENS MEDICAL SOLUTIONS USA, INC. DEBBIE PEACOCK
K043016 11/02/2004 SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICK J LYNCH
K042995 11/01/2004 X-LEONARDO SIEMENS MEDICAL SOLUTIONS USA, INC. ANA LADINO
K043289 11/29/2004 E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT SIGNAL MEDICAL CORP. LOUIS A SERAFIN, JR.
K043082 11/08/2004 THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM SIGNUS MEDIZINTECHNIK GMBH TRACY L GRAY
K043150 11/16/2004 AMADEUS II EPIKERATOME SIS LTD. SURGICAL INSTRUMENT SYSTEMS KEVIN WALLS
K043252 11/23/2004 CABLING SYSTEM TROCHANTER HOOK SMITH & NEPHEW, INC. JOHN REABE
K043052 11/05/2004 TRIGEN HINDFOOT FUSION NAIL SMITH & NEPHEW, INC. JANET JOHNSON AKIL
K043062 11/08/2004 MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM SOURCE-RAY, INC. RAY MANEZ
K043135 11/12/2004 SPSMEDICAL SPORVIEW PA CULTURE SET SPS MEDICAL SUPPLY CORP. GARY J SCOLA
K042957 11/02/2004 DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT SSL AMERICAS CHRIS ROBINSON
K042958 11/02/2004 DUREX PLAY TINGLING LUBRICANT SSL AMERICAS, INC. CHRIS ROBINSON
K043155 11/26/2004 STARION UNIVERSAL POWER SUPPLY (UPS) STARION INSTRUMENTS BRIAN GRIGSBY
K043022 11/04/2004 STRYKER FLEXIBLE CYSTONEPHROSCOPE STRYKER ENDOSCOPY CHRISTOPHER L COOK
K043021 11/04/2004 STRYKER URETEROSCOPE STRYKER ENDOSCOPY CHRISTOPHER L COOK
K043250 11/23/2004 STRYKER PATIENT SPECIFIC POLYMER IMPLANT STRYKER LEIBINGER WADE T RUTKOSKIE
K043180 11/17/2004 STRYKER SPINE TRIO PS STRYKER SPINE SIMONA VOIC
K043282 11/26/2004 DEVILBISS AUTOADJUST, MODEL 9054 SERIES SUNRISE MEDICAL STEPHEN KREPELKA
K043200 11/18/2004 SIGN FIN NAIL SURGICAL IMPLANT GENERATION NETWORK (SIGN) DOUGLAS J DONNELLY
K043008 11/01/2004 SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM SURGRX, INC. LINDA OLESON
K043045 11/04/2004 SYNTHES (USA) CHRONOS SYNTHES (USA) KATHY ANDERSON
K043039 11/04/2004 SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE SYNTHES (USA) KATHY ANDERSON
K043185 11/17/2004 SYNTHES 3.5MM CORTEX SCREWS SYNTHES (USA) LISA M BOYLE
K043258 11/24/2004 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 TELEFLEX MEDICAL SUSAN KAGAN
K043205 11/19/2004 RUSCH EASY TUBE TELEFLEX MEDICAL LORI HAYS
K043075 11/08/2004 TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING TENACORE HOLDINGS, INC. BRAND CASO
K043278 11/26/2004 TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES TERATECH CORP. CHARLES F HOTTINGER
K043011 11/01/2004 TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION NANCY KRUNIC
K043077 11/16/2004 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM TORNIER LEMERY MIREILLE
K043078 11/08/2004 NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K043111 11/10/2004 PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K043160 11/15/2004 TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO TRACOE MEDICAL GMBH MICHAEL A WARREN
K043263 11/24/2004 TRIMED OSTEOTOMY PLATE TRIMED, INC. KELLI ANDERSON
K043012 11/02/2004 OMNIPULSE MINI, MODEL 2120 TRIMEDYNE, INC. GLENN YEIK
K043119 11/10/2004 AMELOGEN PLUS ULTRADENT PRODUCTS, INC. TAMMY LAVERY
K043139 11/12/2004 USCOM 1A USCOM, LTD. CHRISTINA KICHULA
K043273 11/26/2004 LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS VALLEYLAB HERBERT VINSON
K043198 11/18/2004 VANGUARD REPROCESSED ARTHROSCOPIC WANDS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
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K043225 11/22/2004 VANGUARD REPROCESSED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043019 11/03/2004 VASCULAR SOLUTIONS SCLERO-KIT VASCULAR SOLUTIONS, INC. SARA L COON
K043084 11/08/2004 PREMERE DELIVERY SHEATH, MODEL PDS VELOCIMED INC. JOHN CARLINE
K043181 11/17/2004 MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM VERTEBRON, INC. LUIS NESPRIDO
K043152 11/15/2004 VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. LUIS NESPRIDO
K043044 11/04/2004 ANTI-I.V. ENTERAL FEEDING SYSTEM VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K043004 11/03/2004 STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K043116 11/26/2004 ICSI-100 VITROLIFE SWEDEN AB MORGAN HUGOSSON
K042996 11/02/2004 COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE VOLCANO THERAPEUTICS, INC. LORRY HUFFMAN
K043194 11/18/2004 VOXAR 3D PRODUCT FAMILY VOXAR LIMITED NEIL PHILLIPS
K043081 11/08/2004 GORE POLYPROPYLENE HERNIA MESH W. L. GORE & ASSOCIATES, INC. MICHAEL IVEY
K043056 11/05/2004 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC BRANDON HANSON
K043286 11/26/2004 ANEROID SPHYGMOMANOMETER, MODEL BK2002 WENZHOU BOKANG INSTRUMENT CO.,LTD ZHANG JIAN
K043203 11/18/2004 WILSON-COOK ENTERAL FEEDING TUBE, "TIGER TUBE" ENTERAL FEEDING TUBE WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K043234 11/22/2004 LIGHT DRAPE WRAPPED IN COMFORT JANE GETSLA
K043083 11/08/2004 ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K043281 11/26/2004 CHARLOTTE HIGH-DEMAND COMPRESSION SCREW WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K043059 11/05/2004 COMPRESSION STAPLE AND SIMPLE STAPLE WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K043099 11/09/2004 LINEAGE HA ACETABULAR SHELLS WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
K043102 11/09/2004 MULTI-USE COMPRESSION SCREW WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K043073 11/08/2004 PROCOTYL-E ACETABULAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K043118 11/10/2004 HYDROGUM SOFT ZHERMACK S.P.A. GERALD W SHIPPS
K043131 11/12/2004 TORPICALGIN ZHERMACK S.P.A. GERALD W SHIPPS
K043270 11/26/2004 SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES ZIMMER GMBH LAURA D WILLIAMS
K043061 11/05/2004 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX ZIMMER TRABECULAR MARCI HALEVI
K043101 11/09/2004 NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS ZIMMER, INC. BRANDON HIPSHER
K043227 11/22/2004 PERIARTICULAR LOCKING PLATES, 2358 SERIES ZIMMER, INC. NOAH BARTSCH


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