FDA 510(k) Applications Received During October, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K033392 10/23/2003 IMMEDIATE STABILIZING IMPLANT (ISI) "O" CO., INC. DAVID D DALISE
K033354 10/20/2003 FEMTEC LASER MICROKERATOME 20/10 PERFECT VISION OPTISCHE GERATE GMBH CAROL PATTERSON
K033356 10/22/2003 VERASOFT ES AALBA DENT, INC. VINCENT BENETTI
K033299 10/14/2003 ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K033254 10/08/2003 FORTE GAMMA CAMERA SYSTEM ADAC LABORATORIES JOY M SACMAR
K033401 10/29/2003 MODIFICATION TO RESQPOD CIRCULATORY ENHANCER ADVANCED CIRCULATORY SYSTEMS, INC. GARY SYRING
K032959 10/03/2003 CIDEX OPA CONCENTRATE ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K033436 10/28/2003 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K033423 10/29/2003 REVOLIX LASER SYSTEMS ALLMED SYSTEMS INC. PETER ALLEN
K033437 10/30/2003 SPHINX LASER SYSTEMS ALLMED SYSTEMS INC. PETER ALLEN
K033311 10/14/2003 ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K033090 10/02/2003 ICON POLYAXIAL PEDICLE SCREW SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K033053 10/24/2003 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD SCHRAYER
K033345 10/20/2003 AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS ANALOGIC CORP. MARVIN ROSENBAUM
K033443 10/29/2003 SPEEDLYSER INFUSION CATHETER KIT ANGIODYNAMICS, INC. TERI JUCKETT
K033333 10/17/2003 SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K033198 10/02/2003 APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 APOZA ENTERPRISE CO. LTD. SHIH MIN-TEH
K033201 10/02/2003 LA500 BLUE LIGHT APOZA ENTERPRISE CO. LTD. SHIH MIN-TEH
K033200 10/02/2003 ARIOL APPLIED IMAGING CORP. DIANE OATES
K033257 10/10/2003 ARTHROCARE ENT PLASMA WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K033256 10/10/2003 ATHENA PELVIC MUSCLE TRAINER II ATHENA FEMININE TECHNOLOGIES, INC. BARBARA SARKIS
K033015 10/03/2003 AXIOM BIOLASER LLLT SERIES-3 AXIOM USA. INC JIM GIBSON
K033380 10/23/2003 BAYER SPECIAL CHEMISTRY CALIBRATORS BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K033379 10/22/2003 BAYER SPECIAL CHEMISTRY CONTROLS BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K033362 10/21/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE BECTON DICKINSON & CO. MICHELLE B BANDY
K033350 10/24/2003 BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER BECTON DICKINSON & CO. M. WENDY BALLESTEROS
K033458 10/30/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST BECTON, DICKINSON & CO. MONICA E GIGUERE
K033279 10/10/2003 GOLD DENTAL CASTING ALLOYS BEGO U.S.A. WILLIAM OREMUS
K033126 10/02/2003 MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM BEHAVIORAL TECHNOLOGY, INC. SUSAN E OLSEN
K033229 10/06/2003 (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES BERNARD TECHNOLOGIES, INC. MICHAEL D LELAH, PHD
K033366 10/21/2003 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 BIO-RAD MARIA ZEBALLOS
K033404 10/29/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) BIO-RAD MARIA ZEBALLOS
K033387 10/24/2003 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD MARIA ZEBALLOS
K033398 10/24/2003 LARYNGEAL AUGMENTATION IMPLANT BIOFORM, INC. JAMES MILLER
K033174 10/06/2003 BMLS03-3 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K033355 10/20/2003 LACTOSCREW SCREW ANCHOR BIOMET ORTHOPEDICS, INC. MARY L VERSTYNEN
K033280 10/10/2003 DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K033233 10/06/2003 LACTOSORB TIBIAL L-15 SCREW AND WASHER BIOMET, INC. PATRICIA SANDBORN BERES
K033383 10/24/2003 TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 BIOSITE INCORPORATED JEFFREY R DAHLEN, PH.D.
K033210 10/03/2003 BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET BIOTEQUE CORP. JENNIFER REICH
K033217 10/03/2003 PHERON PTA CATHETER BIOTRONIK, INC. JON BRUMBAUGH
K033320 10/20/2003 SCOUT PRO BIOTRONIK, INC. JON BRUMBAUGH
K032976 10/24/2003 BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K033441 10/29/2003 BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER BOSTON SCIENTIFIC CORP. HEIDI M ERICKSON
K033287 10/22/2003 EXACTRAC GATING BRAINLAB AG RAINER BIRKENBACH
K033316 10/29/2003 TABLE TILT DEVICE BRAINLAB AG RAINER BIRKENBACH
K033438 10/28/2003 BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K033245 10/07/2003 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. BARD, INC. MICHAEL A PATZ
K033294 10/16/2003 HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER C.R. BARD, INC. GLENN NORTON
K033389 10/23/2003 POWERPICC CATHETERS, MODELS 3175155, 3175135 C.R. BARD, INC. MICHAELA RIVKOWICH
K033331 10/24/2003 CANDELA CBEAM PULSE DYE LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K033461 10/30/2003 CANDELA VBEAM PULSE DYE LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K033364 10/24/2003 CHAD THERAPEUTICS SAGE CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K033147 10/02/2003 CLEARTOOTH DIGITAL X-RAY SYSTEM CLEARTOOTH ELECTRONICS, INC. GREG HOLLAND
K033301 10/14/2003 IV ADMINISTRATION AND CONNECT SETS CODAN US CORP. ROHIT PATEL
K033213 10/03/2003 CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS CODENT TECHNICAL INDUSTRY CO., LTD. JEN KE-MIN
K033395 10/24/2003 CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 CODMAN & SHURTLEFF, INC. LIZ DOLAN
K033344 10/22/2003 LIGAND PLUS CONTROL LEVEL 1-3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K033348 10/22/2003 ZILVER 518 BILIARY STENT COOK, INC. LELAND KEYT
K033394 10/23/2003 CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035" DELIVERY SYSTEM CORDIS CORP. KAREN WILK
K033183 10/24/2003 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 CURELIGHT LTD JONATHAN S KAHAN
K032988 10/02/2003 ELPHA 4 CONTI DANMETER A/S HANNE NIELSEN
K033215 10/03/2003 PREPAIR DANVILLE MATERIALS, INC. CRAIG R BRUNS
K033281 10/14/2003 DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE DATEX-OHMEDA JOEL KENT
K033273 10/17/2003 DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. NATALIE HECK
K033272 10/15/2003 DEPUY SIGMA TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K033338 10/22/2003 PINNACLE REVISION SYSTEM DEPUY ORTHOPAEDICS, INC. BOB FRIDDLE
K033382 10/24/2003 SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K033329 10/16/2003 DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS DEPUY, INC. RHONDA MYER
K033385 10/23/2003 DGH 55 HANDHELD PACHYMETER (PACHMATE) DGH TECHNOLOGY, INC. M. LUTHER DETWEILER
K033234 10/06/2003 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER DIAGNOSTIC PRODUCTS CORP. EDWARD LEVINE
K033426 10/27/2003 LIAISON N-TACT PTH DIASORIN, INC. DAVID M IKEDA
K033323 10/16/2003 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING DIDECO S.P.A. BARRY SALL
K033440 10/29/2003 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION KEVIN MCLAUGHLIN
K033381 10/30/2003 DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL DISCUS DENTAL INC. STEVEN L ZIEMBA
K033227 10/06/2003 LUXAFORM PLUS DMG USA, INC. PAMELA PAPINEAU
K033305 10/14/2003 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033312 10/15/2003 EBI TOP LOADING MAS SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K033463 10/31/2003 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE EDWARDS LIFESCIENCES LLC. JASON SMITH
K033250 10/07/2003 EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR EDWARDS LIFESCIENCES, LLC. JASON SMITH
K033466 10/31/2003 COLOR LCD DISPLAY, MODEL RADIFORCE R22 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K033214 10/03/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K033399 10/24/2003 GEODESIC EEG SYSTEM SERIES 100 ELECTRICAL GEODESICS, INCORPORATED ROBERT S MCQUATE
K033340 10/17/2003 LEKSELL SURGIPLAN WITH IMAGEMERGE ELEKTA INSTRUMENT AB PETER LOWENDAHL
K033206 10/02/2003 EPW FOLDABLE POWER WHEELCHAIR, EPW-03 EMG TECHNOLOGY CO., LTD. JEN KE-MIN
K033204 10/02/2003 ESG 4-WHEEL SCOOTER, ESG-03 EMG TECHNOLOGY CO., LTD. JEN KE-MIN
K033211 10/03/2003 ENSITE SYSTEM ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K033421 10/27/2003 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS ERBE USA, INC. JULIE STEPHENS
K033269 10/16/2003 ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K033337 10/17/2003 ULTRAPRO MESH ETHICON, INC. REY LIBROJO
K033314 10/15/2003 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K033452 10/30/2003 CWAS 1000 FASSTECH LEE BRODY
K033368 10/29/2003 FOSSA URETERAL OPEN LUMEN STENT FOSSA MEDICAL, INC. GLORIA KOLB
K033370 10/21/2003 POWERED WHEELCHAIR, MODEL FR168W FREERIDER, CORP. ROBERT S MCQUATE
K033193 10/27/2003 SONOSENS FRIENDLY SENSORS AG TRISH LANDRY
K033377 10/22/2003 FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K033209 10/03/2003 FUKUDA DENSHI MODEL FF SONIC UF-750XT FUKUDA DENSHI USA, INC. LARRY D WALKER
K033262 10/17/2003 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) GAMBRO RENAL PRODUCTS KAE MILLER
K033365 10/21/2003 APEXPRO FH TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K033304 10/20/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K033400 10/24/2003 SENO ADVANTAGE GE MEDICAL SYSTEMS W-400 LARRY A KROGER, PH.D.
K033244 10/07/2003 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K033360 10/29/2003 DIAZYME LITHIUM ENZYMATIC ASSAY KIT GENERAL ATOMICS CHONG YUAN
K033409 10/27/2003 AMERSHAM HEALTH NEEDLE-GUARD GETTIG PHARMACEUTICAL INSTRUMENT CO. JAMES A BENZ
K033351 10/20/2003 GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. CARL KNOBLOCH
K033393 10/23/2003 ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM GUIDANT CORP. KELLY PIKE
K033406 10/24/2003 SMALL BONE FIXATION SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K032969 10/06/2003 HELICA "TC" LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE HELICA INSTRUMENTS, LTD JOHN B WEBB
K033248 10/07/2003 HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K033224 10/06/2003 HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER HOLOGIC, INC. DANIEL F PHELAN
K033258 10/09/2003 BONESAVE BONE VOID FILLER HOWMEDICA OSTEONICS LORRAINE MONTEMURRO
K033342 10/17/2003 SCORPIO KNEE SYSTEM - TIBIAL INSERTS HOWMEDICA OSTEONICS CORP. DENISE DUCHENE
K033283 10/14/2003 CENTRA VIEW DEVICE LINK SYSTEM ICU DATASYSTEMS, INC. SAMUEL W COONS
K033290 10/15/2003 TALON INFUSION SET, MODEL IP XXXX ICU MEDICAL, INC. DALE FAIRCHILD
K033188 10/07/2003 TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 IDEV TECHNOLOGIES, INC. LYNNE A DAVIES
K033292 10/27/2003 AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 IGC-MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K033242 10/07/2003 KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) IMAGING THERAPEUTICS, INC. LYNDALL ERB
K033430 10/28/2003 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 IMPLANT INNOVATIONS, INC. TAMARA NELSON
K033384 10/23/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ IMPLEX CORP. MARCI HALEVI
K033415 10/27/2003 IDI-MRSA INFECTIO DIAGNOSTIC (I.D.I.) INC. CHRISTIAN CHOQUET
K033194 10/03/2003 INION CPS BABY 1.5 BIOABSORBABLE SYSTEM INION LTD. HANNA MARTTILA
K033074 10/01/2003 INION GTR BIODEGRADABLE MEMBRANE SYSTEM INION LTD. HANNA MARTTILA
K033251 10/09/2003 THE FRIENDLYLIGHT ND: YAG LASERS INNOTECH USA, INC. HOWARD M HOLSTEIN
K033414 10/27/2003 ACL TOP MODEL, TOP INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K033187 10/01/2003 INTERLAB IMMUNOFIXATION TEST(S) INTERLAB S.R.L. GARY LEHNUS
K033192 10/03/2003 RH-950 IOMED, INC. CURTIS JENSEN
K033462 10/31/2003 EARLY CLEAVAGE MEDIUM (ECM) IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K033199 10/02/2003 COMPACT DIGITAL CARDIAC CAMERA (CDCC) IS2 MEDICAL SYSTEMS, INC. VICTOR WOODBURN
K033208 10/02/2003 IVY DEVICES INC. IV/MEDICAL LINE STABILIZER IVY DEVICES, INC. WILLIAM REILLY
K033221 10/14/2003 KAVO EVEREST ZH-BLANK KAVO AMERICA CORPORATION DANIEL KAMM
K033186 10/10/2003 KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 KING SYSTEMS CORP. TOM MCGRAIL
K033189 10/10/2003 KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 KING SYSTEMS CORP. TOM MCGRAIL
K033267 10/22/2003 EPRICORD KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K033259 10/09/2003 LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 LIGHT AGE, INC. THOMAS HAUCK
K033202 10/02/2003 ADVANTAGE PADDLE LIVINGSTON PRODUCTS, INC. DANIEL KAMM
K033205 10/03/2003 MANOA BREAST BIOPSY SYSTEM MANOA MEDICAL, INC. ROBERTA LEE
K033349 10/20/2003 AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 MASIMO CORP. JAMES J CRONIN
K033296 10/14/2003 MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V MASIMO CORP. JAMES J CRONIN
K033298 10/14/2003 SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS MASIMO CORP. JAMES J CRONIN
K033293 10/16/2003 MED-LOGICS, MODEL ML7090 MED-LOGICS, INC. ROD ROSS
K033179 10/01/2003 MEDELA CLARIO HOME CARE PUMP MEDELA AG WERNER FREI
K033197 10/03/2003 INOGEN SATELLITE CONSERVER MEDICAL ELECTRONIC DEVICES, INC. THOMAS WENZEL
K033266 10/09/2003 VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS MEDICAL IMAGING APPLICATIONS LLC MILAN SONKA
K033247 10/07/2003 MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC. TROY A JACK
K033334 10/20/2003 PROFILE -ER MEDTOX DIAGNOSTICS, INC. ALAN MORRIS
K033264 10/09/2003 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K033416 10/27/2003 SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K033275 10/10/2003 LIFEPAK 12, 20, 500, CR PLUS MEDTRONIC PHYSIO-CONTROL CORP. MICHELLE ACKERMANN
K033271 10/10/2003 DYNALOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K033322 10/15/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K033330 10/17/2003 CONDUCTIVITY/TDS CALIBRATOR SOLUTION MESA LABORATORIES, INC. TODD ROMERO
K033253 10/08/2003 S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR MICRO CURRENT TECHNOLOGY, INC. DAVID SUZUKI
K033372 10/29/2003 SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K033390 10/23/2003 COLIBRI DISPOSABLE VITRECTOMY CUTTER MICROWORLD MEDICAL INSTRUMENTS, INC. SEMYON GAMBARIN
K032965 10/01/2003 LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K033095 10/01/2003 SMOKE EVACUATION ATTACHEMENT MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K033003 10/01/2003 SUCTION COAGULATOR MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K033277 10/10/2003 HYDRAGEL CSF ISOFOCUSING KITS MORAX BOREK JANIK
K031819 10/01/2003 DIO-DENT 10 DENTAL DIODE LASER MSQ (M2) LTD. ARAVA HACOHEN
K033142 10/02/2003 POWERED WHEELCHAIR NATS CORP. STEPHEN T MLCOCH
K033321 10/21/2003 SELECTIVA SB GUIDEWIRE NEO METRICS, INC. MARK PEDERSON
K033427 10/31/2003 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K033315 10/15/2003 SUPEROPEN 0.23T, MODEL NAM-P023A NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. WANG ZHIQIANG
K033324 10/22/2003 COMPRESSION ANASTOMOSIS CLIP (CAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K033307 10/15/2003 NVISION DATA MANAGEMENT SOFTWARE NONIN MEDICAL, INC. JOHN R DALPEE
K033231 10/07/2003 SPINA SYSTEM NORTH AMERICAN MEDICAL CORP (NAM) GIDGETTE RUBIN
K033433 10/28/2003 NOVA GLUCOSE CONTROL SOLUTIONS NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K033295 10/14/2003 BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K033270 10/10/2003 NOVOSCI READY SYSTEM, MODEL RS-200 NOVOSCI CORP. LEANN LATHAM
K033328 10/20/2003 NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT NOVOSCI CORP. LEANN LATHAM
K033386 10/27/2003 NXSTAGE PUREFLOW SOLUTION NXSTAGE MEDICAL, INC. NORMA LEMAY
K033225 10/06/2003 EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. TINA STEFFANIE-OAK
K033222 10/03/2003 OLYMPUS STERILIZATION TRAYS OLYMPUS WINTER & IBE GMBH TINA STEFFANIE-OAK
K033317 10/20/2003 SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K033212 10/03/2003 LIFESTENT SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES JIM CLOSSICK
K033300 10/14/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. CHARLOTTE BAKER
K033286 10/14/2003 ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM ORTHOPEDIC DESIGNS, INC. (ODI) JOHN SODEIKA
K033130 10/17/2003 PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR OSYPKA MEDICAL, INC. MARKUS J OSYPKA
K033120 10/06/2003 SCALETRON PIEZO ULTRASOUND SCALER PAC-DENT INTERNATIONAL (SUZHOU), LTD. DANIEL WANG
K033141 10/02/2003 MECHANICAL WHEEHCHAIR PACIFIC MEDICAL SUPPLIERS, INC. STEPHEN T MLCOCH
K033230 10/07/2003 TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA PARALLAX MEDICAL, INC. LINDA PAUL
K033444 10/29/2003 PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K033357 10/22/2003 ACQSIM-MULTISLICE-CT, MODEL 453567042271 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT B SMITH
K033326 10/16/2003 "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM PHILIPS MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K033017 10/15/2003 PHOENIX INFUSION CATHETER PHOENIX BIOMEDICAL COURTNEY SMITH
K033402 10/24/2003 PORTABLE SLEEP DATA RECORDER (PSDR) PRO-TECH SERVICES, INC. NEIL SHELLER
K033449 10/29/2003 PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC JOANN UNDERWOOD
K033291 10/15/2003 TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 RADI MEDICAL SYSTEMS AB HELENE EKSTRAND
K033181 10/01/2003 SPR SYSTEM RADIANCY (ISRAEL) LTD. JONATHAN S KAHAN
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K033391 10/23/2003 MEDICAL MAGGOTS RONALD A. SHERMAN RONALD A SHERMAN
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K033376 10/23/2003 UGYTEX MESH SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
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K033325 10/20/2003 AMBIT CONTINUOUS AMBULATORY INFUSION PUMP SORENSON MEDICAL, INC. DOUGLAS BUESCHEL
K033425 10/27/2003 AMBIT INTERMITTENT AMBULATORY INFUSION PUMP SORENSON MEDICAL, INC. DOUGLAS BUESCHEL
K033310 10/16/2003 REMEEX SYSTEM FOR URINARY INCONTINENCE SPECIALITIES REMEEX INTERNATIONAL, S.L. JEFFREY R SHIDEMAN
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K033243 10/10/2003 ITI SYNOCTA MESO ABUTMENTS STRAUMANN USA LINDA JALBERT
K033232 10/06/2003 COLORADO MICRODISSECTION NEEDLE STRYKER CORP. WADE T RUTKOSKIE
K033252 10/17/2003 MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM STRYKER ENDOSCOPY MELISSA MURPHY
K033359 10/21/2003 DEGALL II GALLBLADDER EXTRACTOR SURGICON, INC. CURTIS RAYMOND
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K033358 10/20/2003 CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 SURGITECH, INC. CHRISTOPHER CROWELL
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K033308 10/14/2003 VINYL EXAMINATION GLOVES, POWDERED TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. IRIS YANG
K033274 10/14/2003 GIARDIA II TECHLAB, INC. DAVID M LYERLY
K033216 10/10/2003 "BZ-576" NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR THE BUZZ GROUP, LLC DANIEL KAMM, P.E.
K033346 10/20/2003 SPI EASY DENTAL IMPLANT PROTECTIVE CAP THOMMEN MEDICAL, AG FLOYD G LARSON
K033347 10/20/2003 MODIFICATION TO: HI-ART SYSTEM TOMOTHERAPY INCORPORATED KENNETH D BUROKER
K033418 10/27/2003 TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K033241 10/06/2003 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 TUNG KENG ENTERPRISE CO., LTD. KE-MIN JEN
K033239 10/06/2003 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 TUNG KENG ENTERPRISE CO., LTD. KE-MIN JEN
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K033453 10/30/2003 KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING TYCO HEALTHCARE GAIL CHRISTIE
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K033451 10/30/2003 HEARTRAK SMART AT/HEARTRAK SMART2 UNIVERSAL MEDICAL, INC. DOUGLAS M LURIO
K033235 10/06/2003 GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
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K032980 10/03/2003 AMI REPROCESSED MULTIPLE CLIP APPLIERS VANGUARD MEDICAL CONCEPTS, INC. MARK ALDANA
K032973 10/03/2003 REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS VANGUARD MEDICAL CONCEPTS, INC. MARK ALDANA
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K033339 10/17/2003 ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K033343 10/17/2003 TRILOGY RADIOTHERAPY DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K033237 10/07/2003 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE VASCULAR SOLUTIONS, INC. DEBORAH L JENSEN
K033352 10/20/2003 VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. BRUCE KHALILI
K033361 10/21/2003 VIATRONIX V3D VASCULAR, REVISION 1.0 VIATRONIX, INC. FRANK DACHILLE
K033446 10/29/2003 APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. RONALD D ARKIN
K033434 10/28/2003 BESTALOY WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. RONALD D ARKIN
K033435 10/28/2003 E-SARANG 86, DM78, DM55 WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. RONALD D ARKIN
K033378 10/22/2003 VITAL SIGNS MONITOR, PROPAQ LT WELCH ALLYN PROTOCOL, INC. DAVE KLEMENTOWSKI
K033313 10/29/2003 QUATRO M FEMORAL COMPONENT WHITESIDE BIOMECHANICS, INC. AMY CRANMER
K033203 10/02/2003 WILSON-COOK TRI-TOME SELECT PLUS WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K033456 10/30/2003 EVOLVE RADIAL PLATE WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
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K033034 10/06/2003 VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS ZIMMER, INC. KAREN CAIN
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