FDA 510(k) Applications Received During January, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K043189 11/17/2004 SONALIS, MODEL 2000 3G ULTRASOUND, INC. PAUL SCHNEIDER
K043015 11/02/2004 3L SURGICAL DRAPES 3L MEDICAL PRODUCTS CO., LTD. GEORGE SU
K043043 11/04/2004 HERMES BOND 2 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K043097 11/09/2004 3VISEON 3MENSIO MEDICAL IMAGING BV CARL ALLETTO
K043217 11/22/2004 A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K040179 01/27/2004 CONTINUM AALBA DENT, INC. VINCENT M BENETTI
K040180 01/27/2004 CONTINUM V AALBA DENT, INC. VINCENT M BENETTI
K040115 01/20/2004 PICCOLO MAGNESIUM TEST SYSTEM ABAXIS, INC. Dennis M Bleile
K040114 01/20/2004 ABBOTT DATA PORT PC, MODEL 12181 ABBOTT LABORATORIES PATRICIA MELERSKI
K043293 11/29/2004 MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U ACRORAD CO., LTD. T. WHIT ATHEY
K040142 01/22/2004 ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE ADAC LABORATORIES COLEEN COLEMAN
K040084 01/15/2004 LIFESTYLE CIRCULATORY ENHANCER ADVANCED CIRCULATORY SYSTEMS, INC. Gary Syring
DEN040001 01/02/2004 CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM ADVANCED DIAGNOSTIC SYSTEMS DEBRA J RASMUSSEN
K040191 01/28/2004 BICONTACT HIP STEM AND FEMORAL HEAD AESCULAP JOYCE KILROY
K043079 11/08/2004 BICONTACT HIP SYSTEM WITH U-CAP AESCULAP KATHY A RACOSKY
K040017 01/06/2004 ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) AESCULAP, INC. JONI L SWOVELAND
K040080 01/15/2004 AESCULAP ABSORBABLE CRANIOFIX AESCULAP, INC. MATTHEW M HULL
K043041 11/04/2004 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 11/15/2004 ALL FLOW PULMONARY FUNCTION FILTER ALLIANCE TECH MEDICAL, INC. KEITH LOWREY
K040015 01/05/2004 MODIFICATION TO PRISMALIX SURGICAL LIGHT ALM S.A. FREDERICK R CATT
K043196 11/18/2004 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K040092 01/16/2004 AMEDITECH IMMU TEST DRUG SCREEN PANEL AMEDITECH, INC. JOHN WU
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
K040082 01/15/2004 PORE-SI BONE GRAFT SUBSTITUTE APATECH LTD. BARRY SALL
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
K040117 01/20/2004 UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT ARROW INDUSTRIES LLC ROBERT SYMINGTON
K040078 01/14/2004 CANNON II PLUS ARROW INTERNATIONAL, INC. BRANDON EPTING
K040100 01/20/2004 ARROW ECHOGENIC INTRODUCER NEEDLE ARROW INTL., INC. WILLIAM G MCLAIN
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
K040070 01/14/2004 ARTELON SPACER CMC-1 ARTIMPLANT AB MARIE MARLOW
K040159 01/23/2004 APM BLOOD PRESSURE MONITOR, MODEL BP108A ASIA PACIFIC MICROSYSTEMS, INC. Ke-Min Jen
K040183 01/27/2004 BISX ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K043241 11/23/2004 LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE MANNING
K040145 01/22/2004 ATA HCM MONOPLACE HYPERBARIC SYSTEM ATA HYPERBARIC CHAMBER MANUFACTURING HUMPHREY KILLAM
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
K040158 01/23/2004 MFCD 2320 BARCO NV FRANK FERGUSON
K040039 01/09/2004 NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K040041 01/09/2004 NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K040040 01/09/2004 NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K040204 01/29/2004 ZYOPTIX XP MICROKERATOME BAUSCH & LOMB, INC. DEBRA L.B. KETCHUM
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
K040181 01/27/2004 ACCESS DHEA-S REAGENT ASSAY BECKMAN COULTER, INC. MARY BETH TANG
K043215 11/19/2004 FLOWCARE PLG CD4 REAGENT BECKMAN COULTER, INC. STAN SUGRUE
K040006 01/02/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE BECTON DICKINSON & CO. MICHELLE B BANDY
K040026 01/07/2004 BD FACS 7-COLOR SETUP BEADS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS CINDY MORROW
K040099 01/20/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. MONICA E GIGUERE
K040106 01/20/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K043117 11/10/2004 BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K040103 01/20/2004 SOUNDSKIN PHOTOTHERAPY SYSTEM BHC INTERNATIONAL, LTD. MICHAEL BREEN
K040056 01/13/2004 BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 BIO-DETEK, INC. ROBERT MORSE
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
K040030 01/07/2004 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 BIOCHECK, INC. ROBIN J HELLEN
K043304 11/30/2004 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 BIOJECT MEDICAL TECHNOLOGIES INC. LAURENCE A POTTER
K043005 11/01/2004 MODIFICATION TO MBCP BIOMATLANTE MYRIAM VINCENT
K040007 01/02/2004 INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
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
K040034 01/08/2004 BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K040104 01/20/2004 COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K040018 01/06/2004 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040140 01/22/2004 IQ GUIDE WIRE BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K040155 01/23/2004 PERIPHERAL CUTTING BALLOON BOSTON SCIENTIFIC CORP. RENUKA KRISHNAN
K040148 01/23/2004 RESOLUTION HEMOSTASIS CLIPPING DEVICE BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040027 01/08/2004 BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM BOSTONSCIENTIFIC CANDICE R BURNS
K040203 01/29/2004 MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 BRANAN MEDICAL CORP. RAPHAEL WONG
K040149 01/23/2004 PSI-TEC PERISTALTIC INFILTRATION PUMP BYRON MEDICAL REGINA S HARRIS
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
K040020 01/06/2004 C.T.M. POWER CHAIR, MODEL HS-1000 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
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
K040152 01/23/2004 BONE CEMENT FOR CRANIOPLASTY Cardinal Health SHARON NICHOLS
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
K040031 01/08/2004 CERAGEM-C THERMAL ACUPRESSURE MASSAGER CERAGEM CO., LTD. SUZAN ONEL
K043133 11/12/2004 AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR CEREMED, INC. TADEUSZ WELLISZ
K040091 01/16/2004 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K040184 01/26/2004 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K040211 01/30/2004 MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. PEGGY HANSEN
K043034 11/03/2004 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS COLLAGEN MATRIX, INC. PEGGY HANSEN
K040194 01/28/2004 COMPUMEDICS SUMMIT IP COMPUMEDICS USA, LTD. ELVIRA GARCIA
K043216 11/22/2004 CADSTREAM VERSION 4.0 CONFIRMA, INC. PATRICA A MILBANK
K040127 01/21/2004 COOK URETERAL BALLOON DILATION CATHETER SET COOK UROLOGICAL, INC. DEBBIE SCHMITT
K043296 11/29/2004 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING COVALON TECHNOLOGIES, INC. PAUL L GUILBAUD
K040216 01/30/2004 CERASORB M ORTHO CURASAN AG ERIC WIECHERT
K040156 01/23/2004 IFL PROFESSIONAL SYSTEM, MODEL C100 CYDEN LIMITED MICHAEL NOEL KIERNAN
K043028 11/03/2004 EMIT II PLUS ECSTASY ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K040133 01/21/2004 URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ANDREA M TASKER
K043255 11/24/2004 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
K040055 01/12/2004 POLYLASE LP DDC TECHNOLOGIES, INC. DMITRY DONSKOY
K043264 11/24/2004 LDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K043136 11/12/2004 ELITY 70 X-RAY DENTAL X-RAY E.U. GEORGE ECHEVERRI
K040144 01/22/2004 QUIXX POSTERIOR RESTORATIVE DENTSPLY INTERNATIONAL P JEFFERY LEHN
K043247 11/23/2004 DUCERA ALLCERAM DENTSPLY INTL. HELEN LEWIS
K040197 01/29/2004 EAGLE ANTERIOR CERVIAL PLATE SYSTEM DEPUY ACROMED LISA GILMAN
K043298 11/30/2004 BLUE ORTHOCORD SUTURE Depuy Mitek RUTH C FORSTADT
K040004 01/02/2004 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
K040166 01/26/2004 DEPUY SIGMA XLK TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
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
K040121 01/20/2004 DERMAWAVE 5000 COMBI MAX SYSTEM DERMAWAVE, LLC ALAN BUNTING
K040101 01/20/2004 MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K040120 01/20/2004 DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS DIASORIN, INC. DAVID M IKEDA
K040053 01/12/2004 PRECISION VPS IMPRESSION MATERIAL DISCUS DENTAL INC. STEVEN L ZIEMBA
K043000 11/01/2004 MODIFICATION TO D-TRONPLUS DISETRONIC MEDICAL SYSTEMS AG Scott Thiel
K040188 01/28/2004 INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE Draeger Medical Systems, Inc. PENELOPE H GRECO
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
K040116 01/20/2004 HAWK INTRAORAL CAMERA AND ACCESSORIES DXM CO., LTD. CAROLANN KOTULA
K040069 01/14/2004 DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR DYMEDIX, INC. Gary Syring
K043047 11/04/2004 DYNATRON IBOX IONTOPHORESIS DEVICE DYNATRONICS CORP. RONALD J HATCH
K040051 01/12/2004 MEGVISION, MODEL EQ1000C SERIES EAGLE TECHNOLOGY, INC. LEWIS FISHER
K040113 01/20/2004 SANDMAN SD20 AMPLIFIER EB NEURO, S.P.A. COLLEEN DENSMORE
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
K040071 01/14/2004 ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN ELITE INTERNATIONAL, INC. BOBBY LING
K043238 11/22/2004 COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K040139 01/22/2004 ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER ENDOBIONICS, INC. KIRK P SEWARD
K040207 01/30/2004 EP-4 CLINICAL STIMULATOR EP MEDSYSTEMS JAMES E KUHN
K043257 11/24/2004 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
K040108 01/20/2004 OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN EST INTERNATIONAL CORPORATION ELIZABETH DENG
K040038 01/08/2004 CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G ETHICON ENDO-SURGERY, INC. KATIE FORDYCE
K043032 11/03/2004 DEALIGHT IPL EUROPRO, INC. GREG KENNEBECK
K043243 11/23/2004 PRIMUS STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K040052 01/12/2004 FINE SURGICAL CIRCUMCISION CLAMP FINE SURGICAL INSTRUMENT CORP. CAROLANN KOTULA
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
K040170 01/26/2004 FRIADENT PLUS DENTAL IMPLANT SYSTEMS FRIADENT GMBH CAROL PATTERSON
K040048 01/12/2004 FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM FUJINON, INC. JOSEPH M AZARY
K043301 11/30/2004 GC TION GINGIVAL PROTECTOR GC AMERICA, INC. TERRY JORITZ
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
K040172 01/26/2004 MODIFICATION TO GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K040050 01/12/2004 INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN JEFF WAGNER
K040125 01/20/2004 SENOGRAPHIC STEREO GE MEDICAL SYSTEMS, INC. LARRY A KROGER
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
K040444 01/20/2004 GE SIGNA 3.0T WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K040010 01/05/2004 GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS GENESIS MEDICAL INTERVENTIONAL, INC. ANNE WORDEN
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 11/16/2004 GRANTALDER RHAPSODY ACCESS PORT AND CATHETER GRANTADLER CORPORTATION MICHAEL LOITERMAN
K043127 11/12/2004 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. GABRIEL J MURACA
K040045 01/12/2004 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) HAMILTON THORNE BIOSCIENCES DIARMAID DOUGLAS-HAMILTON
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
K040086 01/16/2004 HEALTH BUDDY WITH BUDDYLINK HEALTH HERO NETWORK, INC. GEOFFREY CLAPP
K043277 11/26/2004 C&G ACUPUNCTURE NEEDLE HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K043050 11/04/2004 HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON, INC. JOHN W MORGAN
K040043 01/12/2004 NDX-40 ALLOY HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043295 11/29/2004 VERSYO.DIRECT HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043239 11/23/2004 HEALTHSTAR ELITE HILL LABORATORIES CO. HOWARD A HILL
K040032 01/08/2004 CENTRAL STATION, VERSION 3.3H HOMMED LLC. TOMMIE J MORGAN
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
K040128 01/21/2004 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS HOWMEDICA OSTEONICS CORP MARGARET F CROWE
K042993 11/01/2004 TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP DENISE DUCHENE
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K043054 11/05/2004 GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL SULTAN CHEMISTS, INC. CLARK SMITH
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K040141 01/22/2004 EMORY CARDIAC TOOLBOX VERSION 2.6 SYNTERMED, INC. KENNETH F VAN TRAIN
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
K040083 01/15/2004 SYNTHES EXTERNAL MIDFACE DISTRACTOR SYNTHES (USA) LISA M BOYLE
K040169 01/26/2004 SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES (USA) SHERI L MUSGNUNG
K040073 01/14/2004 SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) SYSMEX AMERICA, INC. NINA GAMPERLING
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K043075 11/08/2004 TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING TENACORE HOLDINGS, INC. Brand Caso
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K040210 01/30/2004 CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR TERUMO CORP. GARRY A COURTNEY
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K040134 01/21/2004 THERILINK BONE VOID FILLER THERICS, INC. JOHNATHAN S KAHAN
K040135 01/22/2004 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K043011 11/01/2004 TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION NANCY KRUNIC
K040110 01/20/2004 EASY LOOP, MODEL EZL-01 TOOLS FOR SURGERY, LLC ARNOLD R LEIBOFF
K040109 01/20/2004 HEMORRHAGE OCCLUDER PIN TOOLS FOR SURGERY, LLC ARNOLD R LEIBOFF
K043077 11/08/2004 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
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K043198 11/18/2004 VANGUARD REPROCESSED ARTHROSCOPIC WANDS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
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K040126 01/20/2004 VIATRONIX V3D COLON, REVISION 1.3 VIATRONIX, INC. BAMAN PATTANAYAK
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K040215 01/30/2004 VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
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K040129 01/21/2004 TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K043203 11/18/2004 WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K040137 01/22/2004 WILSON-COOK USW CAP AND WIRE LOCK WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K040195 01/28/2004 CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM WITT BIOMEDICAL CORP ELFRIEDE PAGAN
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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
K040105 01/20/2004 YUE PFONG SAFETY SYRINGE (3ML) YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD. JENNIFER REICH
K040111 01/20/2004 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
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
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