FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K043581 |
12/28/2004 |
DUAL LUMEN CATHETER |
ACMI CORPORATION |
GRAHAM BAILLIE |
K043507 |
12/20/2004 |
ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K043361 |
12/07/2004 |
ACCUHEART ELECTRODE BELT |
ADVANCED BIOELECTRIC CORPORATION |
MARC-ANDRE COTE |
K043353 |
12/06/2004 |
OMEGA EXCEL/XP LASER SYSTEM |
ADVANCED MEDICAL TECHNOLOGIES, INC. |
M. JOYCE HEINRICH |
K043487 |
12/17/2004 |
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 |
AIZU OLYMPUS CO., LTD. |
LAURA STORMS-TYLER |
K043392 |
12/10/2004 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K043393 |
12/10/2004 |
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
JENN SELVEY |
K043358 |
12/06/2004 |
REPROCESSED ULTRASONIC SCALPELS |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
K043543 |
12/20/2004 |
BLOOD GLUCOSE MONITORING SYSTEM |
AMERICAN HEALTHCARE INC. |
EDWARD LETKO |
K043512 |
12/20/2004 |
EASYGLUCO IGM-0002 G2 |
AMERICAN HEALTHCARE INC. |
EDWARD LETKO |
K043550 |
12/23/2004 |
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 |
AMPLIFE CORPORATION |
SUSAN GOLDSTEIN-FALK |
K043508 |
12/20/2004 |
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) |
ANSELL HEALTHCARE PRODUCTS LLC |
LON D MCILVAIN |
K043350 |
12/06/2004 |
MISTAR, MODEL V3.2 |
APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. |
QING YANG |
K043519 |
12/20/2004 |
ARIOL HER-2/NEU FISH |
APPLIED IMAGING CORP. |
DIANE C DAY |
K043337 |
12/03/2004 |
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR |
ARTHREX, INC. |
SALLY FOUST |
K043422 |
12/13/2004 |
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K043579 |
12/28/2004 |
ATRICURE BIPOLAR SYSTEM |
ATRICURE, INC. |
ELSA C ABRUZZO, RAC |
K043582 |
12/28/2004 |
OCEAN CHEST DRAIN |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
K043554 |
12/27/2004 |
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 |
B-K MEDICAL A/S |
VILLY BRAENDER |
K043524 |
12/20/2004 |
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 |
B-K MEDICAL A/S |
VILLY BRAENDER |
K043311 |
12/01/2004 |
ASCENSIA ELITE DIABETES CARE SYSTEM |
BAYER HEALTHCARE, LLC |
GEORGE M TANCOS |
K043556 |
12/27/2004 |
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K043397 |
12/10/2004 |
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
K043458 |
12/15/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K043389 |
12/09/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K043423 |
12/13/2004 |
MODEL SC-3008 SEQUENTIAL CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
RON MOTHERWELL |
K043341 |
12/03/2004 |
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
CHRISTOPHER BENTSEN |
K043584 |
12/28/2004 |
LIQUICHEK BNP CONTROL |
BIO-RAD LABORATORIES, INC. |
SUZANNE S PARSONS |
K043514 |
12/20/2004 |
ALLOGRAN-N-BONE VOID FILLER |
BIOCOMPOSITES LTD. |
STEPHEN BRATT |
K043428 |
12/13/2004 |
RELIADENT DENTAL IMPLANT SYSTEM |
BIOINFERA, INC. |
CHAN Q WANG |
K043371 |
12/08/2004 |
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
K043547 |
12/23/2004 |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM |
BIOMET, INC. |
GARY BAKER |
K043505 |
12/20/2004 |
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM |
BIOMET, INC. |
GARY BAKER |
K043537 |
12/22/2004 |
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K043598 |
12/29/2004 |
FC 1400 FETAL MONITOR |
BIONET CO., LTD. |
SUN-YOUNG JEONG |
K043597 |
12/29/2004 |
FC 700 FETAL MONITOR |
BIONET CO., LTD. |
SUN-YOUNG JEONG |
K043542 |
12/23/2004 |
BIOPRO TARA FEMORAL RESURFACING COMPONENT |
BIOPRO, INC. |
DAVID MRAK |
K043521 |
12/20/2004 |
BIOSYAG 50 MED |
BIOS S.R.L. |
ALESSANDRO FRANCHI ONDE |
K043548 |
12/23/2004 |
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
K043338 |
12/03/2004 |
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN CIPORKIN |
K043502 |
12/20/2004 |
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K043518 |
12/20/2004 |
RADIOPAQUE BONE CEMENT |
Cardinal Health |
SHARON NICHOLS |
K043590 |
12/28/2004 |
SE INFUSION SYSTEM WITH MMS |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
K043575 |
12/27/2004 |
DERMILLUME, MODEL PRO1000 |
CARE ELECTRONICS, INC. |
THOMAS MOODY |
K043580 |
12/28/2004 |
ALLIGATOR RETRIEVAL DEVICE (ARD) |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
ANNA LONGWELL |
K043558 |
12/27/2004 |
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A |
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. |
GEORGE SU |
K043570 |
12/27/2004 |
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD |
CONFORMIS, INC. |
LYNDALL ERB |
K043418 |
12/13/2004 |
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH |
COOK UROLOGICAL, INC. |
CINDY RUMPLE |
K043509 |
12/20/2004 |
GUNTHER TULIP VENA CAVA FILTER SET |
COOK, INC. |
EARL E KNIGHT III |
K043481 |
12/15/2004 |
MODIFICATION TO: ZILVER 635 BILIARY STENT |
COOK, INC. |
LELAND KEYT |
K043605 |
12/30/2004 |
INSCOPE 3-STAGE BALLOON DILATOR |
CORDIS EUROPA, N.V. |
HARM HOVINGA |
K043538 |
12/22/2004 |
HYPERTRANSIT INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
K043522 |
12/20/2004 |
ISSYS PEDICLE SCREW SYSTEM |
CUSTOM SPINE, INC. |
DEBBIE IAMPIETRO |
K043326 |
12/02/2004 |
BEWELL, MODEL SC 20 |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
CHANG WAN LAN |
K043332 |
12/02/2004 |
WHEELCHAIR, MODEL 8500-II |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
ZEN-JYE CHEN |
K043429 |
12/13/2004 |
CYNERGY LASER |
CYNOSURE, INC. |
GEORGE CHO |
K043546 |
12/23/2004 |
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE |
DADE BEHRING, INC. |
STANLEY GORAK |
K043545 |
12/23/2004 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K043476 |
12/16/2004 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K043589 |
12/28/2004 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K043572 |
12/27/2004 |
COMPATIBILITY ECG TRUNK CABLES |
DATEX-OHMEDA |
JOEL C KENT |
K043551 |
12/23/2004 |
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
K043539 |
12/22/2004 |
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES |
DEMETECH CORP. |
ARTHUR WARD |
K043330 |
12/02/2004 |
POLYPROPILENE SURGICAL SUTURES |
DEMETECH CORP. |
ARTHUR WARD |
K043308 |
12/01/2004 |
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K043406 |
12/10/2004 |
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
DEPUY SPINE,INC |
SHARON STAROWICZ |
K043530 |
12/21/2004 |
DVI CURING LIGHT |
DESIGNS FOR VISION, INC. |
MARY MCNAMARA-CULLINANE |
K043344 |
12/06/2004 |
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM |
DIALYSIS SERVICES, INC. |
MIKE STERLING |
K043323 |
12/02/2004 |
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
DIDECO S.R.L. |
BARRY SALL |
K043491 |
12/17/2004 |
ENFANTTM |
DIOPSYS INC. |
JOSEPH FONTANETTA |
K043409 |
12/10/2004 |
ACCUCHANGER |
DIREX SYSTEMS CORP. |
LARISA GERSTEIN |
K043328 |
12/02/2004 |
MICROFLO-SAFE SCALP VEIN SET |
DKS LOVERSAN INDUSTRIA BIOMEDICA SPA |
ARTHUR WARD |
K043461 |
12/15/2004 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
T. WHIT ATHEY |
K043549 |
12/23/2004 |
INFINITY GATEWAY SUITE, VF4 |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K043439 |
12/14/2004 |
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K043378 |
12/08/2004 |
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT |
DREW SCIENTIFIC LTD. |
DIANE HILL |
K043309 |
12/01/2004 |
GEODESIC PHOTOGRAMMETRY SYSTEM |
ELECTRICAL GEODESICS, INCORPORATED |
LINDA J BOVARD |
K043520 |
12/20/2004 |
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR |
EMG TECHNOLOGY CO., LTD. |
LEONARD FRIER |
K043446 |
12/14/2004 |
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER |
EMMEBI SRL |
MARJORIE BUSH |
K043489 |
12/17/2004 |
ENPATH DEFLECTABLE CATHETER |
ENPATH MEDICAL INCORPORATED |
KARYL D HASKELL |
K043463 |
12/15/2004 |
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
K043467 |
12/15/2004 |
FLEXIBLE SPINAL NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
K043403 |
12/10/2004 |
CEMEX SYSTEM GENTA FAST BONE CEMENT |
EXACTECH, INC. |
Lisa Simpson |
K043527 |
12/21/2004 |
RELIEVA SINUS BALLOON DILATION CATHETER |
EXPLORAMED NC1, INC. |
WILLIAM M FACTEAU |
K043553 |
12/27/2004 |
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 |
FOX HOLLOW TECHNOLOGIES |
MELISSA MURPHY |
K043363 |
12/07/2004 |
FRESENIUS LIBERTY CYCLER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K043407 |
12/10/2004 |
INF 4160, MODEL D-FJ27F |
FUJI DYNAMICS LIMITED |
ANTHONY AH YIN SHUM |
K043525 |
12/21/2004 |
CATHETER INTRODUCER |
GALT MEDICAL CORP. |
DAVID CATLIN |
K043342 |
12/06/2004 |
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR |
GAMBRO RENAL PRODUCTS |
KAE MILLER |
K043471 |
12/16/2004 |
FUSION FAST |
GC AMERICA, INC. |
TERRY L JORITZ |
K043493 |
12/17/2004 |
FUSION PUTTY TYPE |
GC AMERICA, INC. |
TERRY JORITZ |
K043381 |
12/09/2004 |
INFINIA LIGHTSPEED |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
K043415 |
12/13/2004 |
CENTRICITY PACS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
CAROL ALLOIAN |
K043346 |
12/06/2004 |
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 |
GENESIS MEDICAL L.L.C. |
PERRY GEREMAKIS |
K043385 |
12/09/2004 |
OSOM HCG COMBO TEST |
GENZYME DIAGNOSTICS |
E.V. GOORCHENKO |
K043352 |
12/06/2004 |
GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR |
GOCANNING TECHNOLOGY LTD. |
JENNIFER REICH |
K043444 |
12/14/2004 |
MULTIPLE, MODEL KTJ-50 |
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. |
GEORGE SU |
K043443 |
12/14/2004 |
ONE STEP HCG URINE PREGNANCY TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
HOWARD MANN |
K043480 |
12/16/2004 |
ENHANCE CLITORAL STIMULATION AID |
GYNAVATIONS, INC. |
DAVID GLOTH |
K043322 |
12/02/2004 |
MIRAMATIC SAFE SYRINGE SYSTEM |
HAGER WORLDWIDE, INC. |
JAMES DELANEY |
K043437 |
12/13/2004 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
K043414 |
12/13/2004 |
HL 188 & HL 189 BODY FAT METER |
HEALTH & LIFE CO., LTD. |
JENNIFER REICH |
K043504 |
12/20/2004 |
PALAIMPACT |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K043376 |
12/08/2004 |
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR |
HOME HEALTH TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K043374 |
12/08/2004 |
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
K043431 |
12/13/2004 |
GAMMA3 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
JENNIFER KOSOY |
K043404 |
12/10/2004 |
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K043331 |
12/02/2004 |
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 |
HUBDIC CO., LTD |
GUENTER GINSBERG |
K043433 |
12/13/2004 |
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA |
HYCOR BIOMEDICAL LTD. |
DANIELLE M KNIGHT |
K043451 |
12/14/2004 |
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR |
HYPHEN BIOMED |
OLA ANDERSON |
K043456 |
12/15/2004 |
MODIFICATION TO SOAKER CATHETER |
I-FLOW CORP. |
SHANE NOEHRE |
K043410 |
12/10/2004 |
EPIPHYSIS SCREW |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
K043336 |
12/03/2004 |
OPTISTRAND, MODEL 1032S |
IBT SA |
RUTH FEICHT |
K043412 |
12/10/2004 |
MODIFICATION TO: VIEWSTATION |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
K043500 |
12/20/2004 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE |
INNOSPINE, INC. |
LARAINE PANGELINA |
K043612 |
12/30/2004 |
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D |
INSTRUMENTARIUM CORP. IMAGING DIVISION |
MARK MASON |
K043459 |
12/15/2004 |
HEMOSIL FACTOR XII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K043427 |
12/13/2004 |
DURAGEN II DURAL REGENERATION MATRIX |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
K043354 |
12/06/2004 |
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 |
INVIVO RESEARCH, INC. |
NEIL BATTISTE |
K043573 |
12/27/2004 |
DYNAGRAFT II DENTAL |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
K043497 |
12/17/2004 |
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV |
J. MORITA USA, INC. |
KEITH A BARRITT |
K043496 |
12/17/2004 |
SPACELINE EMCIA, MODEL CU580 |
J. MORITA USA, INC. |
KEITH A BARRITT |
K043498 |
12/17/2004 |
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE |
J. MORITA USA, INC. |
KEITH A BARRITT |
K043468 |
12/16/2004 |
WILLI GELLER CREATION II PORCELAIN |
JENSEN INT'L, INC. |
GARY PHELPS |
K043531 |
12/21/2004 |
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
K-JUMP HEALTH CO., LTD. |
DANIEL TSENG |
K043375 |
12/08/2004 |
FISCH TITANIUM MIDDLE EAR PROSTHESES |
KARL STORZ ENDOSCOPY |
YVONNE FERNANDEZ |
K043324 |
12/02/2004 |
AIDA WITH DICOM AND HL7 INTERFACE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
K043591 |
12/28/2004 |
FEATHERLIFT EXTENDED APTOS THREAD |
KMI KOLSTER METHODS, INC. |
KEITH DAVIS |
K043367 |
12/08/2004 |
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE |
LACE ELECTRONICA S.R.L. |
IAN P GORDON |
K043314 |
12/01/2004 |
MANZI CLEANER SYSTEM |
LANGFORD IC SYSTEMS, INC. |
TERRY LANGFORD |
K043484 |
12/17/2004 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
DAVID W SCHLERF |
K043370 |
12/08/2004 |
PLANET 50 MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
K043347 |
12/06/2004 |
BF+ |
LDR SPINE USA |
BRIAN BURKINSHAW |
K043479 |
12/16/2004 |
MC+ PARTIAL VBR |
LDR SPINE USA |
BRIAN BURKINSHAW |
K043349 |
12/06/2004 |
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) |
LDR SPINE USA |
BRAIN BURKINSHAW |
K043357 |
12/06/2004 |
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
K043534 |
12/22/2004 |
MODIFICATION TO OUTBACK CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
K043506 |
12/20/2004 |
ACUPUNCTURE NEEDLES |
MARKNEW PRODUCTS |
GREG HOLLAND |
K043494 |
12/17/2004 |
MASTEL LASER CLEAN ROOM, MODEL EBS-100 |
MASTEL PRECISION SURGICAL INSTRUMENTS, INC. |
MERLE GOERINGER |
K043544 |
12/23/2004 |
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR |
MEDELA AG |
WERNER FREI |
K043614 |
12/30/2004 |
VACULINK, MODEL VCL 3000 |
MEDEVCO, INC. |
KRISTA OAKES |
K043419 |
12/13/2004 |
P&P SAFETY SYRINGE |
MEDEXEL MEDICAL MFG. CO., LTD. |
DANIEL KAMM |
K043523 |
12/20/2004 |
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
NICOHL WILDING |
K043454 |
12/15/2004 |
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 |
MEDICOMP, INC. |
SUSAN D GOLDSTEIN-FALK |
K043472 |
12/16/2004 |
MEDIN TECH ZIRCONIA-CP10, SS1000 |
MEDIN TECH |
ABDESLAM KASSEH |
K043455 |
12/15/2004 |
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
CARL ALLETTO |
K043585 |
12/28/2004 |
MEDLINE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K043600 |
12/29/2004 |
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C |
MEDTRONIC MINIMED |
GERDA P RESCH |
K043568 |
12/27/2004 |
EQUESTRA FLUID DELIVERY SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
K043488 |
12/17/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K043561 |
12/27/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD A TREHARNE |
K043566 |
12/27/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
K043321 |
12/02/2004 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K043343 |
12/06/2004 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K043602 |
12/29/2004 |
QUADRANT RETRACTOR SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K043564 |
12/27/2004 |
HORIZON ANGIO CATHLAB |
MENNEN MEDICAL LTD. |
MICHA OESTEREICH |
K043586 |
12/28/2004 |
LASER SYS*STIM 540, MODEL ME 540 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
K043528 |
12/21/2004 |
SPIROTEL |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K043380 |
12/08/2004 |
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 |
MONEBO TECHNOLOGIES, INC. |
DALE J MISCZYNSKI |
K043398 |
12/10/2004 |
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE |
NEO METRICS, INC. |
GENE CHAMPEAU |
K043373 |
12/08/2004 |
DOLOTENS DENTAL TM 1 |
NEUROMUSCULAR TECHNOLOGIES, INC. |
MARIE JENSEN |
K043517 |
12/20/2004 |
TRANSMITTER, ZS-940PA SERIES |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K043312 |
12/01/2004 |
NOBELRONDO DENTAL CERAMIC - ZIRCONIA |
NOBEL BIOCARE USA, LLC |
ELIZABETH J MASON |
K043526 |
12/21/2004 |
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
PATRICIA DAVIDSON |
K043359 |
12/06/2004 |
4100 PATIENT OXIMETER MODULE |
NONIN MEDICAL, INC. |
JOHN R DALPEE |
K043462 |
12/15/2004 |
CZR PRESS LF |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
K043319 |
12/02/2004 |
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES |
NOVALIS MEDICAL, LLC |
ANTHONY DAVIS |
K043541 |
12/22/2004 |
ENDOLINK TRUE MOVEMENT SYSTEM |
NOVARE SURGICAL SYSTEMS, INC. |
GREGORY MATHISON |
K043405 |
12/10/2004 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K043436 |
12/13/2004 |
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K043460 |
12/15/2004 |
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
K043384 |
12/09/2004 |
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
K043386 |
12/09/2004 |
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
K043536 |
12/22/2004 |
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
K043434 |
12/13/2004 |
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
K043615 |
12/30/2004 |
OXYTEC, MODEL 900 |
OXYTEC MEDICAL CORPORATION |
PAUL E DRYDEN |
K043557 |
12/27/2004 |
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS |
PANORAMIC CORP. |
DANIEL KAMM |
K043587 |
12/28/2004 |
SUCRALFATE AND CARAFATE PASTE KITS |
PATRICK D. MCGRATH PH.D |
PATRICK D MCGRATH |
K043388 |
12/09/2004 |
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH |
PEGASUS BIOLOGICS, INC. |
MUIR S MEINHOLD |
K043599 |
12/29/2004 |
MOMENTS MENOPAUSE CHECK, MODEL 9113 |
PHAMATECH INC. |
CARL A MONGIOVI |
K043535 |
12/22/2004 |
HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
STEVE SINGLAR |
K043317 |
12/02/2004 |
OMNILUX PLUS |
PHOTO THERAPEUTICS LIMITED |
STEVEN G HUTSON |
K043329 |
12/02/2004 |
OMNILUX REVIVE AND BLUE |
PHOTO THERAPEUTICS LIMITED |
STEVE G HUTSON |
K043383 |
12/09/2004 |
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 |
PHYSION, INC. |
ERIC J NEMETH, ESQ. |
K043360 |
12/07/2004 |
IMT.LAB |
PIE MEDICAL |
CARRI GRAHAM |
K043588 |
12/28/2004 |
MYLAB 15 / MYLAB 20, MODEL 2700 |
PIE MEDICAL |
CARRI GRAHAM |
K043408 |
12/10/2004 |
PIEZOSURGERY DEVICE |
PIEZOSURGERY SRL |
Maria E Donawa |
K043571 |
12/27/2004 |
CRYOCHECK CLOT S |
PRECISION BIOLOGIC INC. |
STEPHEN L DUFF |
K043613 |
12/30/2004 |
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II |
QUANTEL MEDICAL |
ROGER W BARNES |
K043421 |
12/13/2004 |
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
K043420 |
12/13/2004 |
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
K043574 |
12/27/2004 |
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 |
RENAL SOLUTIONS, INC. |
RICHARD CONFER |
K043411 |
12/10/2004 |
RESOFIX BIOABSORBABLE EXPANSION BOLT |
RESOFIX, INC. |
CARL KNOBLOCH |
K043607 |
12/30/2004 |
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
ZITA A YURKO |
K043529 |
12/21/2004 |
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K043474 |
12/16/2004 |
ACCU-CHEK AVIVA SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K043320 |
12/02/2004 |
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K043318 |
12/02/2004 |
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K043327 |
12/02/2004 |
ONLINE DAT BENZODIAZEPINES PLUS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
DEN040011 |
12/20/2004 |
AMPLICHIP CYP450 TEST, MODEL 04381866190 |
ROCHE MOLECULAR SYSTEMS, INC. |
JAMES F KELLY |
K043576 |
12/27/2004 |
ROCHE AMPLICHIP CYP450 TEST |
ROCHE MOLECULAR SYSTEMS, INC. |
JAMES F KELLY |
K043325 |
12/02/2004 |
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES |
ROLENCE ENTEPRISE, INC. |
STERLING CHENG |
K043369 |
12/08/2004 |
CERVEX-BRUSH COMBI |
ROVERS MEDICAL DEVICES B.V. |
IR. M.D. ZWART |
K043441 |
12/14/2004 |
MIRAGE, RELEASE 5.5 |
SEGAMI CORPORATION |
PHILIPPE BRIANDET |
K043425 |
12/13/2004 |
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) |
SHEATHING TECHNOLOGIES, INC. |
LARRY POLAYES |
K043563 |
12/27/2004 |
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K043348 |
12/06/2004 |
MODIFICATION TO PM-8000 PATIENT MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K043499 |
12/17/2004 |
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
EMMY TJOENG |
K043478 |
12/16/2004 |
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
EMMY TJOENG |
K043475 |
12/16/2004 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
CHEN YUHONG |
K043477 |
12/16/2004 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
CHEN YUHONG |
K043379 |
12/08/2004 |
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 |
SHIMADZU CORP. |
RANDAL WALKER |
K043469 |
12/16/2004 |
SYNGO INSPACE 4D |
SIEMENS AG, MEDICAL SOLUTIONS |
RUEDIGER KOERNER |
K043316 |
12/02/2004 |
RABEA SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K043355 |
12/06/2004 |
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X |
SINTEA BIOTECH, INC. |
GUIDO ZORZOLI |
K043306 |
12/01/2004 |
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR |
SKYLARK DEVICE & SYSTEMS CO., LTD |
BETTY CHIEN |
K043395 |
12/10/2004 |
SMITH & NEPHEW VIDEOARTHROSCOPE |
SMITH & NEPHEW, INC. |
KATHLEEN BURNS |
K043440 |
12/14/2004 |
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM |
SMITH & NEPHEW, INC. |
GINO ROUSS |
K043495 |
12/17/2004 |
BABYPAC |
SMITHS MEDICAL INTERNATIONAL LTD., LUTON |
DONALD ALEXANDER |
K043483 |
12/17/2004 |
RADIN, MODEL V 3.0 |
SOHARD AG |
RALPH LOOS |
K043578 |
12/28/2004 |
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
K043511 |
12/20/2004 |
SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 |
SOLEUS CHAMP INTERNATIONAL CO., LTD. |
Ke-Min Jen |
K043559 |
12/27/2004 |
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
SONOSITE,INC. |
DAINA L GRAHAM |
K043452 |
12/15/2004 |
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM |
SONOSITE,INC. |
DAINA L GRAHAM |
K043307 |
12/01/2004 |
CRANEX D |
SOREDEX PALODEX GROUP OY |
KAI LANER |
K043465 |
12/15/2004 |
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 |
SPECTRANETICS CORP. |
ADRIAN E ELFE |
K043401 |
12/10/2004 |
SPECTRANETICS LLD CS, MODEL 518-039 |
SPECTRANETICS CORP. |
MICHAEL J RYAN |
K043457 |
12/15/2004 |
MODIFICATION TO ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
GARY RAUVOLA |
K043592 |
12/29/2004 |
REPROCESSED ENDOSCOPIC TROCAR |
STERILMED, INC. |
BRUCE R LESTER |
K043453 |
12/15/2004 |
STERILEMED REPROCESSED IVUS IMAGING CATHETER |
STERILMED, INC. |
BRUCE LESTER |
K043513 |
12/20/2004 |
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER |
STERILMED, INC. |
BRUCE R LESTER |
K043482 |
12/17/2004 |
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 |
STERIS Corporation |
MARGARET MARSH |
K043334 |
12/03/2004 |
BONE SOURCE HAC RAPID SETTING CEMENT |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
K043466 |
12/15/2004 |
PAINPUMP2 |
STRYKER INSTRUMENTS |
JENNIFER MARS |
K043442 |
12/14/2004 |
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE |
STRYKER INSTRUMENTS |
JEAN SHEPPARD |
K043473 |
12/16/2004 |
MODIFICATION TO XIA SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K043435 |
12/13/2004 |
QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
K043533 |
12/22/2004 |
SURGICAL DESIGN CIRCUMCISION CLAMP |
SURGICAL DESIGN, INC. |
MOHAMMAD BASHIR |
K043310 |
12/01/2004 |
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
K043555 |
12/27/2004 |
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR |
SYNTHES (USA) |
KATHY ANDERSON |
K043593 |
12/29/2004 |
SPINE-FIX BIOMIMETIC BONE CEMENT |
TEKNIMED SA |
J. D. WEBB |
K043596 |
12/29/2004 |
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 |
THERAGENICS CORP. |
BETSY CORTELLONI |
K043402 |
12/10/2004 |
THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
K043438 |
12/14/2004 |
LARGE BORE SPLITTABLE INTRODUCER KIT |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
K043382 |
12/09/2004 |
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
K043366 |
12/08/2004 |
PERMACOL SURGICAL IMPLANT |
TISSUE SCIENCE LABORATORIES, PLC |
VICTORIA TAYLOR |
K043486 |
12/17/2004 |
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 |
TOPCON MEDICAL LASER SYSTEMS, INC |
JOHN JOSSY |
K043430 |
12/13/2004 |
20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K043351 |
12/06/2004 |
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N |
TRIAGE MEDICAL INC |
GAYLE HIROTA |
K043377 |
12/08/2004 |
ZENO |
TYRELL, INC. |
DARLA J ELKIN |
K043594 |
12/29/2004 |
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
K043315 |
12/01/2004 |
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
K043387 |
12/09/2004 |
VASCON POLARIS GUIDING CATHETER |
VASCON LLC |
STEPHEN F VADAS |
K043552 |
12/27/2004 |
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES |
VASCUTEK LTD. |
STEVEN ARICK |
K043562 |
12/27/2004 |
BC PLUS |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
K043515 |
12/20/2004 |
GRAFTSAVER |
VESCARE, INC. |
DAVID WALSH |
K043490 |
12/17/2004 |
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE |
VIDACARE CORPORATION |
GREG HOLLAND |
K043340 |
12/03/2004 |
EZ SMART |
VIP DIAGNOSTICS LLC |
DAVID L ROSEN |
K043368 |
12/08/2004 |
VITELCARE TURTLE, MODEL 400 |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
ALLEN IZADPANAH |
K043503 |
12/20/2004 |
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 |
VISX, INCORPORATED |
ALAN F RUSSELL |
K043333 |
12/03/2004 |
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K043604 |
12/29/2004 |
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE |
VIVOMETRICS, INC. |
HOWARD M HOLSTEIN |
K043396 |
12/10/2004 |
INTEGRITY, MODEL V500 |
VIVOSONIC, INC. |
EDWARD GOSS |
K043540 |
12/22/2004 |
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES |
WESTCON CONTACT LENS CO., INC. |
CAROL NOBLE |
K043583 |
12/28/2004 |
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K043339 |
12/03/2004 |
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG |
XTREMI-T, LLC |
SHAWN T HUXEL |
K043356 |
12/06/2004 |
WAGNER SL REVISION STEM LATERAL |
ZIMMER AUSTIN, INC. |
AUDREY SWEARINGTON |
K043565 |
12/27/2004 |
MODIFICATION TO DYNESYS SPINAL SYSTEM |
ZIMMER SPINE, INC |
TIM CRABTREE |
K043560 |
12/27/2004 |
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 |
ZIMMER, INC. |
LAURA D WILLIAMS |