| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K052235 |
09/27/2005 |
LCR |
3M COMPANY |
KAREN O'MALLEY |
| K052063 |
09/30/2005 |
HUANQIU HEATING LAMP |
A & A MEDICAL SUPPLIES INC |
GEORGE SU |
| K051291 |
09/20/2005 |
NON-STERILE SURGICAL MASK |
A.R. MEDICOM, INC. |
LUC TREPANIER |
| K052247 |
09/14/2005 |
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
| K052454 |
09/14/2005 |
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM |
ABBOTT VASCULAR DEVICES |
DEBBIE COGAN |
| K052325 |
09/14/2005 |
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
| K051593 |
09/02/2005 |
UROPASS URETERAL ACCESS SHEATH, MODEL 61224 |
ACMI CORPORATION |
GRAHAM BAILLIE |
| K051515 |
09/01/2005 |
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K052418 |
09/26/2005 |
AXXESS BUTTERFLY ANCHOR |
ADVANCED NEUROMODULATION SYSTEMS |
STEVE TAMSETT |
| K051712 |
09/01/2005 |
MODEL 2800 PFT FILTER |
AIR SAFETY LTD |
PAUL DRYDEN |
| K050729 |
09/14/2005 |
ALCON MULTI-PURPOSE DISINFECTING SOLUTION |
ALCON RESEARCH, LTD. |
KIM B KRACKE |
| K052375 |
09/09/2005 |
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 |
ALILIFE TECHNOLOGICAL CO., LTD. |
Ke-Min Jen |
| K051852 |
09/14/2005 |
SINGLE AMPLIFIER FOR BOTOX |
ALLERGAN, INC. |
SUSAN O'BRIEN |
| K050518 |
09/23/2005 |
REPROCESSED PHACOEMUISIFICATION TIPS |
ALLIANCE MEDICAL, INC. |
ELIZABETH RENKEN |
| K051260 |
09/15/2005 |
SCHUCO MIST AND SCHUCO DELUXE MIST |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K051830 |
09/16/2005 |
NEURODRIVE SYSTEM |
ALPHA OMEGA LTD. |
SHLOMO PUNDAK |
| K050352 |
09/01/2005 |
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT |
AMERITEK RESEARCH LLC |
KUD CHAIANG YEE |
| K052447 |
09/21/2005 |
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 |
ANALOGIC CORP. |
DONALD SHERRATT |
| K051779 |
09/30/2005 |
ANDROFLOW - RESPIRATORY RATE MONITOR |
ANDROMED, INC. |
GEORGE PAPAGIANNIS |
| K051655 |
09/12/2005 |
ANGIODYNAMICS, INC., MICRO ACCESS KITS |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K050629 |
09/02/2005 |
ANGIOSCULPT SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
GARY GERSHONY |
| K051831 |
09/07/2005 |
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM |
APPLIED SURGICAL, LLC |
DAVID A ALEXANDER |
| K051726 |
09/27/2005 |
ARTHREX TENODESIS FAMILY |
ARTHREX, INC. |
QNN WATERHOUSE |
| K052614 |
09/28/2005 |
LOW PROFILE PLATE AND SCREW SYSTEM |
ARTHREX, INC. |
SALLY FOUST |
| K051820 |
09/06/2005 |
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K051772 |
09/26/2005 |
ASAHI TORNUS SUPPORT CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K052362 |
09/09/2005 |
BIS EEG MONITOR, MODEL A-3000 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K051332 |
09/29/2005 |
ADVANTA T-GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K052047 |
09/22/2005 |
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 |
AVENT AMERICA, INC. |
RICHARD MORRONEY |
| K051404 |
09/27/2005 |
B-CARE POWDER FREE LATEX EXAMINATION GLOVES |
B-CARE INDUSTRIES CO., LTD. |
RUJIRA PHANPHIPHAT |
| K052352 |
09/30/2005 |
COLOR CORONIS 2MP-21 AND MFCD 2321 |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052403 |
09/15/2005 |
CORONIS 2MP-21 AND MFGD 2621 |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052429 |
09/15/2005 |
CORONIS 3MP-21 AND MFGD 3621 |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052529 |
09/30/2005 |
E-2320 PA S |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052478 |
09/28/2005 |
MFCD 1219, MFCD 1219 TS |
BARCOVIEW |
LIEVEN DE WANDAL |
| K052276 |
09/21/2005 |
NIO 2MP-20 AND E-2620 S |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052282 |
09/20/2005 |
VENAFLO II VASCULAR GRAFT |
BARD PERIPHERAL VASCULAR, INC. |
GLENN NORTON |
| K051899 |
09/13/2005 |
BD PEN NEEDLE |
BECTON DICKINSON & CO. |
JOHN SCHALAGO |
| K052250 |
09/30/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K052224 |
09/12/2005 |
BD PROBE TEC URINE PRESERVATIVE TRANSPORT |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K051091 |
09/01/2005 |
SYNTHOGRAFT |
BICON, INC. |
VINCENT J MORGAN |
| K051397 |
09/16/2005 |
BIOBANDS |
BIOBANDS DISTRIBUTORS, INC. |
JAMES H HARTTEN |
| K052419 |
09/20/2005 |
MAXIMUS 3.0 AND OS IMPLANTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K051885 |
09/16/2005 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K052311 |
09/29/2005 |
VITEK 2 GRAM NEGATIVE TIGECYCLINE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K051843 |
09/29/2005 |
COPELAND EAS HUMERAL RESURFACING HEADS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K050327 |
09/27/2005 |
E-POLY (VITAMIN E) ACETABULAR LINERS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K051975 |
09/06/2005 |
POROUS COATED DISCOVERY ELBOW |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051569 |
09/29/2005 |
RINGLOC BI-POLAR ACETABULAR COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051775 |
09/06/2005 |
OSTEOMIMETIC SYNTHETIC BONE MATRIX |
BIOMIMETIC PHARMACEUTICALS INC. |
SANDRA WILLIAMSON |
| K042681 |
09/29/2005 |
CARTO RMT EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
DIANA THORSON |
| K052083 |
09/29/2005 |
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER |
BIOSENSE WEBSTER, INC. |
DIANA M THORSON |
| K042998 |
09/29/2005 |
REFSTAR RMT EXTERNAL REFERENCE PATCH |
BIOSENSE WEBSTER, INC. |
MARK O'DONNELL |
| K051787 |
09/22/2005 |
TRIAGE BNP TEST, MODEL 98000XR |
BIOSITE INCORPORATED |
JEFFREY DAHLEN |
| K051629 |
09/23/2005 |
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 |
BLEASE USA, INC. |
ARTHUR J WARD |
| K051507 |
09/02/2005 |
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
ALBERT ZICKMANN |
| K051951 |
09/28/2005 |
CERAMENT BONE VOID FILLER |
BONE SUPPORT AB |
JEFFREY R SHIDEMAN |
| K052302 |
09/12/2005 |
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K050863 |
09/02/2005 |
IMAGER II ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC CORP. |
Diane Brinza |
| K052220 |
09/30/2005 |
IPLAN RT FIBERTRACKING |
BRAINLAB AG |
RAINER BIRKENBACH |
| K052517 |
09/29/2005 |
SITE-RITE 5 ULTRASOUND SYSTEM |
C.R. BARD, INC. |
KIMBERLY GEISLER |
| K051279 |
09/07/2005 |
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 |
CALDYNE, INC. |
TOM SHANKS |
| K052219 |
09/13/2005 |
CRONO GO. |
CANE S.R.L. |
CARLO MUSSO |
| K052217 |
09/13/2005 |
CRONO SUPER PID |
CANE S.R.L. |
CARLO MUSSO |
| K051789 |
09/30/2005 |
VISANTE OCT |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K051887 |
09/27/2005 |
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) |
CARLETON LIFE SUPPORT SYSTEMS INC. |
GARY BYRD |
| K051938 |
09/21/2005 |
TRITON/TRU-TRAC/TX TRACTION DEVICES |
CHATTANOOGA GROUP |
CHERYL BAGWELL |
| K041820 |
09/09/2005 |
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K051838 |
09/01/2005 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 |
CONCENTRIC MEDICAL, INC. |
JEAN M CAILLOUETTE |
| K052009 |
09/28/2005 |
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR |
CONMED CORPORATION |
PAMELA VETTER |
| K051048 |
09/23/2005 |
SURGISIS STAPLE LINE REINFORCEMENT II |
COOK BIOTECH, INC. |
MARK BLEYER |
| K051494 |
09/21/2005 |
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 |
CR TECH, LTD. |
LEONARD FRIER |
| K051130 |
09/09/2005 |
VCS S3Y |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC |
CHANG WAN LAN |
| K050382 |
09/14/2005 |
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM |
CYNOSURE, INC. |
GEORGE CHO |
| K051922 |
09/14/2005 |
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 |
CYNOSURE, INC. |
GEORGE CHO |
| K051537 |
09/26/2005 |
HILT FAMILY LASER: HILT I, HILT II, HILT III |
CYNOSURE, INC. |
GEORGE CHO |
| K051910 |
09/02/2005 |
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER |
D.B.I. AMERICA CORP. |
UBIRACI R FERNANDES |
| K052017 |
09/01/2005 |
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K052015 |
09/12/2005 |
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K051650 |
09/08/2005 |
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K051895 |
09/27/2005 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K052593 |
09/28/2005 |
FUSION CURING LIGHT |
DENTLIGHT INC. |
RICHARD LIU |
| K052334 |
09/02/2005 |
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 |
DENTSPLY INTL. |
HELEN LEWIS |
| K052131 |
09/28/2005 |
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS |
DEPUY SPINE, INC. |
LIZ LAVELLE |
| K052551 |
09/30/2005 |
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE |
DEVON SAFETY PRODUCTS, INC. |
BARRY L BERLER |
| K051357 |
09/20/2005 |
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH |
DIGITIMER LTD. |
HARRY J BENEDICT |
| K052150 |
09/08/2005 |
VOLAR PLATE SYSTEM |
DVO EXTREMITY SOLUTIONS, LLC |
DINA L WEISSMAN |
| K051281 |
09/08/2005 |
THE NEEDLE CATCHER |
E.D.MEDICAL LTD. |
BRIAN MCNICHOLL |
| K052239 |
09/21/2005 |
EBI DYNAFIX VISION FOOTPLATE SYSTEM |
EBI, L.P. |
PETER ALLAN |
| K052149 |
09/02/2005 |
EDWARDS PERIPHERAL DILATION CATHETER |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K051825 |
09/12/2005 |
COGNITRACE |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
DANIEL KAMM |
| K052344 |
09/14/2005 |
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K052337 |
09/08/2005 |
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K051749 |
09/13/2005 |
COBRA SURGICAL SYSTEM |
ESTECH, INC. |
CRAIG COOMBS |
| K051701 |
09/29/2005 |
VICRYL * MESH BAG |
ETHICON, INC. |
JENNIFER PAINE |
| K051556 |
09/06/2005 |
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE |
EXACTECH, INC. |
DIANA TAYLOR |
| K042564 |
09/30/2005 |
HEMOR-RITE CRYOTHERAPHY |
FAMA HOLDINGS INTERNATIONAL CORP |
FRANK MELENDEZ |
| K052422 |
09/27/2005 |
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) |
FLOW X-RAY CORP. |
SUSAN D GOLDSTEIN-FALK |
| K052345 |
09/14/2005 |
ADVANTAGE SIM MD |
GE HEALTHCARE |
LARRY A KROGER |
| K052167 |
09/08/2005 |
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K051873 |
09/20/2005 |
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES |
GE HEALTHCARE |
JOEL C KENT |
| K052412 |
09/16/2005 |
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ |
GE HEALTHCARE |
LARRY A KROGER |
| K052434 |
09/27/2005 |
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
GE MEDICAL SYSTEMS |
ELI WERNER |
| K042782 |
09/02/2005 |
SEER MC |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
GRACE LEMIEUX |
| K052293 |
09/21/2005 |
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER, PH.D. |
| K052441 |
09/21/2005 |
GE LOGIQ 7 ULTRASOUND BT05 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K051730 |
09/26/2005 |
MATRIX HOLTER SYSTEM, MODEL M12 |
GLOBAL INSTRUMENTATION, LLC |
CRAIG SELLERS |
| K052274 |
09/21/2005 |
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 |
GUIDANT CORPORATION |
M. LAURIE WONG |
| K051594 |
09/02/2005 |
MCCARTNEY ACCESS TUBE |
GYNETECH PTY. LTD. |
DENNIS HAHN |
| K052248 |
09/14/2005 |
DORSAL NAIL PLATE, ANATOMICAL |
HAND INNOVATIONS, LLC. |
ERNESTO HERNANDEZ |
| K050085 |
09/14/2005 |
OSTEOPAL V |
HERAEUS KULZER GMBH |
CHRISTIAN TUCHSCHERER |
| K052172 |
09/27/2005 |
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K050448 |
09/23/2005 |
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 |
HORIBA ABX |
TIM LAWTON |
| K052117 |
09/09/2005 |
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) |
I-FLOW CORP. |
SHANE NOEHRE |
| K052008 |
09/16/2005 |
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 |
IMC-HEARTWAY, LLC |
JOHN FRYMARK |
| K051461 |
09/15/2005 |
3I OSSEOTITE DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUEYL A HUGHES |
| K051978 |
09/23/2005 |
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT |
IMPLEX CORP. |
MARCI HALEVI |
| K051667 |
09/27/2005 |
EZ-JECT |
INDOLOR, LTD. |
GEORGE J HATTUB |
| K052444 |
09/20/2005 |
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K052329 |
09/21/2005 |
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 |
INNOVATIVE NEUROTRONICS INC. |
FAYYAZ MEMON |
| K051540 |
09/21/2005 |
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR |
INOVO, INC. |
KEVIN CONFOY |
| K051160 |
09/02/2005 |
MANIPUSEAL |
INSITU SYSTEMS |
MARY MCNAMARA-CULLINANE |
| K051440 |
09/20/2005 |
MAYFIELD INFINITY SKULL CLAMP |
INTEGRA LIFESCIENCES CORP. |
DONNA R WALLACE |
| K052098 |
09/07/2005 |
CONNEXUS, .5CC, MODEL 023000-005 |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
| K051782 |
09/20/2005 |
BLUEPHASE 16I |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K050999 |
09/02/2005 |
YI XIN STERILE SYRINGE FOR SINGLE USE |
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP |
YUN YUAN GAO |
| K052214 |
09/13/2005 |
PRE-POWDERED STERILE EXAM GLOVES |
KANAM LATEX INDUSTRIES PVT. LTD. |
RAVI ABRAHAM |
| K052159 |
09/07/2005 |
AIDA COMPACT II SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL LEE |
| K050443 |
09/02/2005 |
ACCU-LEAD |
KENTEC MEDICAL, INC. |
DAVID SHERATON |
| K051611 |
09/06/2005 |
MBARESORB IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
| K051552 |
09/19/2005 |
O.A.S.I. SYSTEM |
LANCER ORTHODONTICS, INC. |
GRACE HOLLAND |
| K052245 |
09/23/2005 |
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS |
LAR MFG., LLC. |
IAN P GORDON |
| K051209 |
09/08/2005 |
LEVITRONIX CENTRIMAG BACK-UP CONSOLE |
LEVITRONIX LLC. |
FARZAD PARSAIE |
| K050435 |
09/06/2005 |
E-STIM II |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K051614 |
09/09/2005 |
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS |
LIFECORE BIOMEDICAL, INC. |
RACHEL KENNEDY |
| K051944 |
09/30/2005 |
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES |
LUMENIS, INC. |
KAREN L BAKER |
| K050524 |
09/14/2005 |
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 |
MARDA MEDICAL, INC. |
Howard Schrayer |
| K051585 |
09/06/2005 |
F-400 SYSTEM |
MAUNA KEA TECHNOLOGIES |
ALEXANDRE LOISEAU |
| K051676 |
09/08/2005 |
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K052330 |
09/09/2005 |
TRU-SWAB STOCOCK |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
TIM TRUITT |
| K051697 |
09/21/2005 |
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM |
MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP |
C. STEPHEN LAWRENCE |
| K051422 |
09/01/2005 |
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE |
MEDISIM LTD. |
AHAVA STEIN |
| K052211 |
09/14/2005 |
DUREPAIR DURA REGENERATION MATRIX |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K052372 |
09/22/2005 |
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K052376 |
09/23/2005 |
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K051320 |
09/09/2005 |
SATELLITE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K052402 |
09/23/2005 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K051018 |
09/02/2005 |
INTERMEZZO IMPLANT SYSTEMS |
MEGAGEN CO., LTD. |
DAE KYU CHANG |
| K051698 |
09/29/2005 |
MERRIES UNI-OSTEO, MODEL CS30250-CS10102 |
MERRIES INTERNATIONAL INC. |
JESSICA LI |
| K051157 |
09/01/2005 |
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS |
MICROMEDICS, INC. |
TOM A LOPAC |
| K051669 |
09/01/2005 |
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
MIGADA PLANT |
YOSSI SHACHAR |
| K043373 |
09/02/2005 |
DOLOTENS DENTAL TM 1 |
NEUROMUSCULAR TECHNOLOGIES, INC. |
MARIE JENSEN |
| K052152 |
09/13/2005 |
B-BOP PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K051740 |
09/06/2005 |
TAPERED COMPRESSION PIN |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K052521 |
09/26/2005 |
NISSIN SERIES MECHANICAL WHEELCHAIR |
NISSIN MEDICAL INDUSTRIES CO., LTD |
DARREN REEVES |
| K051835 |
09/23/2005 |
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K033231 |
09/09/2005 |
SPINA SYSTEM |
NORTH AMERICAN MEDICAL CORP (NAM) |
GIDGETTE RUBIN |
| K052024 |
09/07/2005 |
NSTRAND IMPLANTATION KIT |
NORTH AMERICAN SCIENTIFIC, INC. |
LEIGH SPOTTEN |
| K051718 |
09/15/2005 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K051469 |
09/28/2005 |
CAREVENT ATV+ AND CAREVENT MRI |
O-TWO MEDICAL TECHNOLOGIES, INC. |
AMMAR AL-DOJALLY |
| K052452 |
09/21/2005 |
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K052154 |
09/08/2005 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K052153 |
09/08/2005 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K050807 |
09/21/2005 |
20G SMA LASER FIBER, MODEL LF100 |
OPHTHALMED LLC |
JAY MANSOUR |
| K050637 |
09/23/2005 |
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K051407 |
09/08/2005 |
LEGEND ALL-POLY CUP |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K051945 |
09/06/2005 |
MIOT PLATING SYSTEM |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K052237 |
09/06/2005 |
SC CERAMIC BALL HEADS |
ORTHOPEDIC ALLIANCE LLC |
HARTMUT LOCH |
| K052027 |
09/29/2005 |
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 |
OSMETECH, INC. |
DANIEL MCMINN |
| K051576 |
09/01/2005 |
AVANA DENTAL IMPLANT SYSTEM |
OSSTEM CO., LTD. |
ALBERT REGO |
| K051876 |
09/09/2005 |
MULTIWAVE XR |
PACIFIC QUANTUM INSTRUMENTS, INC. |
GENNADY L NIKOLAENKO |
| K052389 |
09/09/2005 |
I-PORT |
PATTON MEDICAL DEVICES |
FRED SCHLADOR |
| K051222 |
09/23/2005 |
AV-S ANAESTHESIA VENTILATOR |
PENLON LIMITED |
BARRY PEARCE |
| K052134 |
09/22/2005 |
CYSTOGLIDE DILATING INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
| K052048 |
09/13/2005 |
ACCORDION |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
| K051134 |
09/08/2005 |
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A |
PHILIPS MEDICAL SYSTEMS |
DANIEL J DILLON |
| K052078 |
09/07/2005 |
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN HARMER |
| K051366 |
09/14/2005 |
PICONIBP OEM MODULE |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K051874 |
09/02/2005 |
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K052579 |
09/27/2005 |
PORTAL GRAVITY SYSTEM |
PORTAL, INC. |
DAVID CARTER |
| K052415 |
09/29/2005 |
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K051192 |
09/06/2005 |
PRAXAIR MEDICAL AIR MIXER |
PRAXAIR, INC. |
TAMARA BROWN |
| K051866 |
09/06/2005 |
PREMIER TEMPORARY CEMENT |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
| K052353 |
09/09/2005 |
Z-CHAIR |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS SCHAPPERT |
| K042991 |
09/23/2005 |
I-NEB AAD SYSTEM |
PROFILE THERAPEUTICS PLC |
BARBARA CAMPBELL |
| K051565 |
09/12/2005 |
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA |
PROTON HEALTHCARE LTD. |
Kevin Walls |
| K052273 |
09/30/2005 |
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE |
PT. MAHAKARYA INTI BUANA |
SASITHARAN NAIR |
| K052382 |
09/15/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K052373 |
09/26/2005 |
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE |
QUILL MEDICAL, INC. |
LOIS V SMART |
| K052005 |
09/06/2005 |
R&R EXTERNAL FIXATION SYSTEM |
R&R MEDICAL, INC. |
J.D. WEBB |
| K051671 |
09/02/2005 |
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K051269 |
09/09/2005 |
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES |
RADIANT INNOVATION INC. |
FRANK LIN |
| K052460 |
09/21/2005 |
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE |
RAMSOFT, INC. |
VIJAY RAMANATHAN |
| K052489 |
09/27/2005 |
ACTIHEART |
RESPIRONICS, INC. |
ZITA A YURKO |
| K051355 |
09/23/2005 |
VANISHPOINT I.V. CATHETER |
RETRACTABLE TECHNOLOGIES, INC. |
MICHELE LARIOS |
| K050760 |
09/13/2005 |
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K051297 |
09/08/2005 |
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K051592 |
09/02/2005 |
MODIFICATION TO ACCU-CHEK GO SYSTEM |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K052464 |
09/30/2005 |
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K052309 |
09/27/2005 |
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 |
SAEHAN CORP. |
CHARLIE MACK |
| K051762 |
09/23/2005 |
SAF-T-SYRINGE/SAF-T-NEEDLE |
SAFETY MEDICAL INTERNATIONAL, INCORPORATED |
DAVID ZARRILLI |
| K051313 |
09/15/2005 |
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER |
SALTER LABS |
DUANE KAZAL |
| K051861 |
09/28/2005 |
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 |
SAVION INDUSTRIES, LTD. |
STELI LOZNEN |
| K051810 |
09/09/2005 |
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K051952 |
09/07/2005 |
EUGENONE |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K052016 |
09/01/2005 |
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING |
SGMP CO., LTD. |
JANNA P TUCKER |
| K051251 |
09/07/2005 |
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
ELVIS GE |
| K051924 |
09/02/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHU XIAOAN |
| K052076 |
09/02/2005 |
DAR-8000I |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K051913 |
09/30/2005 |
POWDERED LATEX PATIENT EXAMINATION GLOVES |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K052031 |
09/12/2005 |
POWDERED LATEX SURGEON'S GLOVE |
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
JANNA P TUCKER |
| K052030 |
09/13/2005 |
SURGEON'S GLOVE, POWDER FREE |
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
ANAN JETSADAWISUT |
| K052461 |
09/22/2005 |
SYNGO IMAGING VERSION V20A |
SIEMENS AG, MEDICAL SOLUTIONS |
EVA-MARIA REITER |
| K052410 |
09/22/2005 |
ACUSON SEQUOIA ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K052305 |
09/08/2005 |
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
BARRY V ASHAR |
| K052315 |
09/22/2005 |
SIMTEC IM-MAXX 2 OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K052216 |
09/08/2005 |
SOMATOM DEFINITION |
SIEMENS MEDICAL SYSTEMS, INC. |
GARY JOHNSON |
| K051859 |
09/23/2005 |
SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM |
SIN SISTEMA DE IMPLANTE NACIONAL LTDA |
FLOYD G LARSON |
| K051661 |
09/06/2005 |
IMPLANT HANDPIECES |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K051940 |
09/28/2005 |
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA |
SIS LTD. SURGICAL INSTRUMENT SYSTEMS |
Kevin Walls |
| K050174 |
09/07/2005 |
BIO-STIM KIT |
SKYLARK DEVICE & SYSTEMS CO., LTD |
BETTY CHIEN |
| K051747 |
09/06/2005 |
SBI WRISTFIT |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
| K051956 |
09/08/2005 |
DR. OPPEL ST-501 |
SOMETECH INCORPORATED |
YOUNG-SOO SEOL |
| K052296 |
09/02/2005 |
CLIRPATH TURBO EXCIMER LASER CATHETERS |
SPECTRANETICS CORP. |
NEIL BURRIS |
| K052084 |
09/14/2005 |
ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
| K052411 |
09/21/2005 |
HIPAX MEDICAL IMAGING SOFTWARE |
STEINHART MEDIZINSYSTEME GMBH |
MARTINA STEINHART |
| K051957 |
09/21/2005 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILEMED INC. |
THOMAS A DOLD |
| K051369 |
09/26/2005 |
SYRYKER SORANO WHEELCHAIR |
STRYKER CANADA |
SHERYL ROBINSON BAGALIO |
| K051741 |
09/26/2005 |
ACCOLADE HFX FEMORAL STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K052542 |
09/27/2005 |
ACCOLADE RPS HIP STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K052181 |
09/08/2005 |
MODIFICATION TO XIA SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052317 |
09/21/2005 |
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K051904 |
09/09/2005 |
ALL PURPOSE CUFF, MODEL 222APC |
SUNTECH MEDICAL, INC. |
DAVID GALLICK |
| K052260 |
09/08/2005 |
SUPERDIMENSION/BRONCHUS 4.1 |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
| K051988 |
09/21/2005 |
OXY-SERVE II OXYGEN CONSERVING REGULATOR |
SUPERIOR PRODUCTS, INC. |
RONALD JOHNSTON |
| K051035 |
09/02/2005 |
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS |
SYNERGEYES |
RICHARD E LIPPMAN |
| K052324 |
09/14/2005 |
POLARIS LV, LVA APPLICATOR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K051986 |
09/08/2005 |
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K051678 |
09/21/2005 |
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K052123 |
09/23/2005 |
SYNTHES PANGEA SYSTEM |
SYNTHES (USA) |
JOHN J WALSH |
| K051665 |
09/09/2005 |
SYNTHES VECTRA-T SYSTEM |
SYNTHES SPINE |
SUSAN LEWANDOWSKI |
| K051459 |
09/23/2005 |
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K052074 |
09/01/2005 |
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, |
SZABOCSIK AND ASSOCIATES |
JOHN M SZABOCSIK |
| K050097 |
09/30/2005 |
TECHNO-SCOPE VISUAL STETHOSCOPE |
TECHTRADE LLC |
ARTHUR M HOROWITZ |
| K052205 |
09/12/2005 |
CAPIOX AF125X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K051997 |
09/15/2005 |
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K052185 |
09/06/2005 |
DESTINATION CAROTID GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K051865 |
09/27/2005 |
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K051915 |
09/06/2005 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K051259 |
09/20/2005 |
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 |
THERALIGHT, INC. |
KEVIN E DALY |
| K052056 |
09/23/2005 |
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM |
THERMO-ELECTRON CORP. |
MELITA LAMBIRIS |
| K052199 |
09/22/2005 |
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K051856 |
09/26/2005 |
TRANS1 FACET SCREWS |
TRANS1 INCORPORATED |
ROBERT L SHERIDAN |
| K052091 |
09/21/2005 |
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K052332 |
09/21/2005 |
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER |
TRUDELL MEDICAL INTL. |
JOHN STRAATMAN |
| K052355 |
09/14/2005 |
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS |
U-SYSTEMS, INC. |
ROBERT F LAWRENCE |
| K051750 |
09/19/2005 |
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
| K042287 |
09/07/2005 |
UNIPLAIN & UNICHROM |
UNITED MEDICAL INDUSTRIES CO. LTD. |
MOHAMMED AZEEZ |
| K051264 |
09/01/2005 |
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS |
UNOMEDICAL A/S |
JOHN LINDSKOG |
| K051616 |
09/06/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K052209 |
09/06/2005 |
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 |
VASCULAR CONTROL SYSTEMS, INC |
KATHLEEN ROBERTS |
| K052232 |
09/28/2005 |
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
| K052554 |
09/23/2005 |
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K051716 |
09/07/2005 |
VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K051857 |
09/15/2005 |
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 |
WEISSBURG ASSOCIATES |
DAVID WEISSBURG |
| K052158 |
09/08/2005 |
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE |
WELCH ALLYN, INC. |
CHRISTOPHER KLACZYK |
| K051112 |
09/07/2005 |
WHITTLESTONE EXPRESSER |
WHITTLESTONE, INC. |
BRUCE MCKENDRY |
| K051966 |
09/07/2005 |
FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY |
WORLDWIDE MEDICAL LLC |
KEVIN J GADAWSKI |
| K043099 |
09/29/2005 |
LINEAGE HA ACETABULAR SHELLS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
| K052559 |
09/26/2005 |
WU'S POWERED WHEELCHAIR, MAMBO 2 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K050388 |
09/07/2005 |
REFIX INTERNAL FRACTURE FIXATION SCREWS |
XTREMI-T, LLC |
SHAWAN T HUXEL |
| K041952 |
09/08/2005 |
ZIVF-AIRE |
ZANDER MEDICAL SUPPLIES, INC. |
FRED ZANDER |
| K050411 |
09/02/2005 |
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM |
ZIMMER, INC. |
CINDY J DICKEY |
