| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K051657 |
06/21/2005 |
A-DEC SELF-CONTAINED WATER SYSTEM |
A-DEC, INC. |
TOM LOUISELL |
| K051719 |
06/27/2005 |
A.B. DENTAL DEVICES |
A.B. DENTAL DEVICES, LTD. |
BENNY ARAZY |
| K051519 |
06/08/2005 |
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) |
ABBOTT LABORATORIES (PERCLOSE, INC.) |
ANN E LEONARD |
| K051593 |
06/16/2005 |
UROPASS URETERAL ACCESS SHEATH, MODEL 61224 |
ACMI CORPORATION |
GRAHAM BAILLIE |
| K051501 |
06/06/2005 |
ZIRACE |
ACUCERA, INC. |
KYUNG-BIN LEE |
| K051515 |
06/08/2005 |
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K051544 |
06/10/2005 |
VITALCAREGIVING SYSTEM |
ADVANCED MONITORING CAREGIVING INC. |
GEORGE MYERS |
| K051643 |
06/20/2005 |
STERRAD STERILIZER CYCLESURE TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH M ASCENZI |
| K051492 |
06/06/2005 |
AESKULISA ASCA A |
AESKU.INC |
STANLEY AMMONS |
| K051589 |
06/15/2005 |
SLIMMANAGER, MODEL SM-X, SM-E |
AIIA COMMUNICATION INC. |
JOHN MYUNG |
| K051712 |
06/27/2005 |
MODEL 2800 PFT FILTER |
AIR SAFETY LTD |
PAUL DRYDEN |
| K051554 |
06/13/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K051438 |
06/01/2005 |
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) |
ALLIANCE MEDICAL, INC. |
MOIRA BARTON |
| K051636 |
06/20/2005 |
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES |
ALTATEC GMBH |
TINA STEFFANIE-OAK |
| K051621 |
06/20/2005 |
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
DONALD V CANAL |
| K051529 |
06/09/2005 |
AMBU NEUROLINE GROUND |
AMBU, INC. |
SANJAY PARIKH |
| K051525 |
06/08/2005 |
ARX SPINAL SYSTEM |
AMEDICA CORP. |
ROBERT M WOLFARTH |
| K051485 |
06/06/2005 |
AMS PELVIC FLOOR REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
| K051530 |
06/09/2005 |
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. |
AMERICAN MEDICAL SYSTEMS, INC. |
DENISE THOMPSON |
| K051655 |
06/21/2005 |
ANGIODYNAMICS, INC., MICRO ACCESS KITS |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K051648 |
06/21/2005 |
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K051432 |
06/01/2005 |
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K051726 |
06/28/2005 |
ARTHREX TENODESIS FAMILY |
ARTHREX, INC. |
QNN WATERHOUSE |
| K051639 |
06/20/2005 |
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM |
AS SOFTWARE, INC. |
KIM A NATHANSON |
| K051561 |
06/13/2005 |
ASAHI ANGIOGRAPHIC CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K051772 |
06/30/2005 |
ASAHI TORNUS SUPPORT CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K051652 |
06/21/2005 |
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY BROWN |
| K051672 |
06/23/2005 |
POWERPICC |
BARD ACCESS SYSTEMS, INC. |
LYNN M KIRCHOFF |
| K051722 |
06/27/2005 |
TRICOS T |
BAXTER HEALTHCARE CORP. |
BRIAN L BISHOP |
| K051619 |
06/17/2005 |
LIPOPROTEIN FOR MULTIPLE ANALYTES |
BAYER HEALTHCARE, LLC |
ANDERS HOLLE |
| K051693 |
06/23/2005 |
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
ANDREA HOLLE |
| K051670 |
06/22/2005 |
RF TUNNELER WIRE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K051692 |
06/23/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K051689 |
06/23/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML |
BECTON, DICKINSON & CO. |
Monica Giguere |
| K051695 |
06/23/2005 |
MARROW PLUS (M+) |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K051620 |
06/17/2005 |
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES |
BETTER WATER, INC. |
MICHAEL CLINE |
| K051675 |
06/23/2005 |
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER |
BIODYNAMICS CORP. |
EDWARD M RIFKIN |
| K051479 |
06/03/2005 |
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS |
BIOMET MANUFACTURING, INC. |
GARY BAKER |
| K051570 |
06/14/2005 |
AVL HINGE KNEE SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051496 |
06/06/2005 |
COBALT BONE CEMENT |
BIOMET, INC. |
LONNIE WITHAM |
| K051532 |
06/09/2005 |
COBALT G HV BONE CEMENT |
BIOMET, INC. |
LONNIE WITHAM |
| K051569 |
06/14/2005 |
RINGLOC BI-POLAR ACETABULAR COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051480 |
06/03/2005 |
ENTERAL FEEDING TUBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
GENE BOYD |
| K051513 |
06/02/2005 |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
BIPORE, INC. |
KEITH PALUCH |
| K051470 |
06/03/2005 |
REMOTE CARE MANAGEMENT SYSTEMS (RCMS) |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
| K051629 |
06/20/2005 |
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 |
BLEASE USA, INC. |
ARTHUR J WARD |
| K051507 |
06/07/2005 |
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
ALBERT ZICKMANN |
| K051679 |
06/23/2005 |
ILAB ULTRASOUND IMAGING SYSTEM |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
| K051504 |
06/07/2005 |
SPYSCOPE ACCESS AND DELIVERY CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER JOHNSON |
| K051417 |
06/01/2005 |
6 FR FL POWERHOHN AND POWERLINE CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K051748 |
06/29/2005 |
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
| K051649 |
06/21/2005 |
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 |
CAMTRONICS MEDICAL SYSTEMS |
STEVE KRUEGER |
| K051641 |
06/20/2005 |
ALARIS SYSTEM PC UNIT, MODEL 8001 |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K051681 |
06/23/2005 |
DERMILLUME RED, MODEL HR1000 |
CARE ELECTRONICS, INC. |
THOMAS O MOODY |
| K051533 |
06/09/2005 |
I-STOP |
CL MEDICAL |
VINCENT GORIA |
| K051435 |
06/01/2005 |
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 |
CLINICAL MICRO SENSORS |
WILLIAM A COTY |
| K051415 |
06/01/2005 |
ENDOTINE RIBBON |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K051660 |
06/22/2005 |
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM |
COLTENE/WHALEDENT INC. |
LORETTA MOONEY |
| K051494 |
06/06/2005 |
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 |
CR TECH, LTD. |
LEONARD FRIER |
| K051443 |
06/02/2005 |
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO |
CURASAN AG, FRANKFURT FACILITY |
ERIC WIECHERT |
| K051537 |
06/10/2005 |
HILT FAMILY LASER: HILT I, HILT II, HILT III |
CYNOSURE, INC. |
GEORGE CHO |
| K051442 |
06/02/2005 |
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT |
CYNOSURE, INC. |
GEORGE CHO |
| K051478 |
06/03/2005 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K051650 |
06/21/2005 |
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K051597 |
06/16/2005 |
STRATUS CS D-DIMER |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K051460 |
06/03/2005 |
C.CAM-AC |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS SORENSEN |
| K051707 |
06/27/2005 |
ECLIPSE BONDING AGENT |
DENTSPLY INTL. |
HELEN LEWIS |
| K051462 |
06/03/2005 |
MODIFICATION TO: CERCON BASE |
DENTSPLY INTL. |
HELEN LEWIS |
| K051463 |
06/03/2005 |
XENO ADHESIVE WITH ACTIVATOR |
DENTSPLY INTL. |
HELEN LEWIS |
| K051711 |
06/27/2005 |
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS |
DENVER BIOMEDICAL, INC. |
NANCY SAUER |
| K051757 |
06/29/2005 |
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
| K051714 |
06/27/2005 |
TOTAL BILE ACIDS ASSAY, MODEL DZ042A |
DIAZYME LABORATORIES |
HUAN TRAN |
| K051549 |
06/13/2005 |
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K051571 |
06/14/2005 |
SKYLIGHT LED CURING LIGHT |
DMETEC CO., LTD. |
CAROLANN KOTULA |
| K051487 |
06/06/2005 |
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE |
DOCTOR'S RESEARCH GROUP, INC. |
MAHMUD AHMED |
| K051573 |
06/14/2005 |
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) |
DR. HOWARD MARTIN, P.A. |
KYLE H SIBINOVIC |
| K051658 |
06/21/2005 |
INFINITY ALPHA |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K051628 |
06/20/2005 |
INFINITY MONITORS WITH SCIO MODIFICATIONS |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K051733 |
06/28/2005 |
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL |
DRG INTL., INC. |
Gary Lehnus |
| K051680 |
06/23/2005 |
DYNATRON DX2 TRACTION UNIT |
DYNATRONICS CORP. |
RON HATCH |
| K051483 |
06/06/2005 |
KODAK DIRECTVIEW DR SYSTEM DETECTOR |
EASTMAN KODAK COMPANY |
CHRISTINE E EHMANN |
| K051724 |
06/27/2005 |
ACUMEN IMAGE GUIDED SURGICAL SYSTEM |
EBI, L.P. |
WHITNEY TORNING |
| K051746 |
06/29/2005 |
ELEKTA ESARTE FRAME SYSTEM |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K051420 |
06/01/2005 |
HABIB 4X |
EMCISION, LTD. |
NAGY HABIB |
| K051509 |
06/07/2005 |
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K051764 |
06/30/2005 |
T-PLATE ANTERIOR FIXATION SYSTEM |
ESM TECHNOLOGIES |
CLIFF TRIBUS |
| K051749 |
06/29/2005 |
COBRA SURGICAL SYSTEM |
ESTECH, INC. |
CRAIG COOMBS |
| K051534 |
06/10/2005 |
CARDIOLINE AR 600, AR 1200, AR 2100 |
ET MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
| K051732 |
06/28/2005 |
ENDOSCOPIC APPLICATOR |
ETHICON INC. |
PETER CECCHINI |
| K051701 |
06/24/2005 |
VICRYL * MESH BAG |
ETHICON, INC. |
JENNIFER PAINE |
| K051455 |
06/02/2005 |
WIESLAB CAP MPO-ANCA |
EURODIAGNOSTICA |
WILLIAM L BOTELER JR. |
| K051458 |
06/02/2005 |
WIESLAB CAP PR-3 ANCA |
EURODIAGNOSTICA |
WILLIAM L BOTELER JR. |
| K051489 |
06/06/2005 |
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM |
EUROIMMUN US LLC |
KATHRYN KOHL |
| K051550 |
06/13/2005 |
INSPIRATION VENTILATOR SYSTEM |
EVENT MEDICAL LTD. |
ROBBIE WALSH |
| K051498 |
06/07/2005 |
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR |
EVER GLOBAL ENTERPRISE CORPORATION |
NICK BIEN |
| K051556 |
06/13/2005 |
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE |
EXACTECH, INC. |
DIANA TAYLOR |
| K051682 |
06/23/2005 |
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM |
EXACTECH, INC. |
MARITZA ELIAS |
| K051684 |
06/23/2005 |
EYEPORT VISION TRAINING SYSTEM |
EXERCISE YOUR EYES, INC. |
JACOB LIBERMAN |
| K051446 |
06/02/2005 |
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS |
FIRST QUALITY HYGIENIC INC. |
ROBERT J STAAB |
| K051580 |
06/15/2005 |
VP SHEATH |
FLOWCARDIA, INC. |
RICHARD SPANO |
| DEN050007 |
06/20/2005 |
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL |
FMG INNOVATIONS, INC. |
LINDA D BENTLEY |
| K051522 |
06/08/2005 |
SILBRONCHO DOUBLE LUMEN TUBE |
FUJI SYSTEMS CORP. |
PAUL E DRYDEN |
| K051553 |
06/13/2005 |
FUJI SYNAPSE WORKSTATION SOFTWARE |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
ROBERT BERRY |
| K051520 |
06/08/2005 |
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K051427 |
06/01/2005 |
GC FUJI FIL LC |
GC AMERICA, INC. |
TERRY L JORITZ |
| K051634 |
06/20/2005 |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION |
GE HEALTHCARE |
JOEL C KENT |
| K051635 |
06/20/2005 |
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K051734 |
06/28/2005 |
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 |
GE HEALTHCARE TECHNOLOGIES |
RAJ KASBEKAR |
| K051449 |
06/02/2005 |
GE VIVID 7 WITH OR WITHOUT SUFFIX |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
| K051673 |
06/23/2005 |
XELERIS 2 PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K051518 |
06/08/2005 |
UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RONALD N BLASKI |
| K051490 |
06/06/2005 |
GE OEC EVERVIEW 7500 |
GE OEC MEDICAL SYSTEMS, INC. |
SUSAN SCHMIDT |
| K051666 |
06/22/2005 |
GAV - GENERAL ANAESTHETIC VAPORIZER |
GENERAL ANAESTHETIC SERVICES LIMITED |
ANDREW JW WALL |
| K051508 |
06/07/2005 |
MED FLASH II INTENSE PULSED LIGHT SYSTEM. |
GENERAL PROJECT S.R.L. |
MAUREEN O'CONNELL |
| K051727 |
06/28/2005 |
AIMSTICK URINE REAGENT STRIPS |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
| K051471 |
06/03/2005 |
CARDIODAY |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
| K051686 |
06/23/2005 |
CARDIOMEM CM 3000-12 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CAROLANN KOTULA |
| K051606 |
06/16/2005 |
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K051730 |
06/27/2005 |
MATRIX HOLTER SYSTEM, MODEL M12 |
GLOBAL INSTRUMENTATION, LLC |
CRAIG SELLERS |
| K051721 |
06/27/2005 |
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
CARL KNOBLOCH |
| K051668 |
06/22/2005 |
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT |
GOODMARK USA, INC. |
ROBERT J MICHALIK |
| K051662 |
06/22/2005 |
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
MICKY LIN |
| K051429 |
06/01/2005 |
CLARIS NON-STICK BIPOLAR FORCEPS |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
CHRISTA HEITMANN-FRANKE |
| K051594 |
06/16/2005 |
MCCARTNEY ACCESS TUBE |
GYNETECH PTY. LTD. |
DENNIS HAHN |
| K051728 |
06/27/2005 |
MODIFICATION TO SHOULDER FIXATION SYSTEM |
HAND INNOVATIONS, LLC. |
ERNESTO HERNANDEZ |
| K051610 |
06/17/2005 |
HANS HERMANN LAPAROSCOPES AND ACCESSORIES |
HANS HERMANN GMBH |
HARALD JUNG |
| K051546 |
06/13/2005 |
BPCALIBRATOR MC3000/MC3100 |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
| K051677 |
06/21/2005 |
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
EMI ZYCHLINSKY |
| K051588 |
06/15/2005 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051737 |
06/28/2005 |
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051738 |
06/28/2005 |
SECUR-FIT MAX AND PLUS MAX HIP STEMS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051624 |
06/20/2005 |
T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K051590 |
06/15/2005 |
T2 ANKLE ARTHRODESIS NAIL |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K051430 |
06/01/2005 |
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) |
HYDROGEL VISION CORPORATION |
DONNA HOVANEC |
| K051472 |
06/03/2005 |
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR |
HYPHEN BIOMED |
OLA ANDERSON |
| K051514 |
06/08/2005 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K051433 |
06/01/2005 |
I-STAT CREATINE KINASE MB (CK-MB) |
I-STAT CORPORATION |
SUE KENT |
| K051642 |
06/20/2005 |
FR.O.H. CALCANEUS REPAIR SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K051437 |
06/01/2005 |
CML 1000 |
ICU MEDICAL, INC. |
JIM COOMBES |
| K051713 |
06/27/2005 |
JBAIDS ANTHRAC DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K051579 |
06/14/2005 |
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051578 |
06/14/2005 |
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051577 |
06/14/2005 |
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051626 |
06/20/2005 |
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K051476 |
06/03/2005 |
UNI-VENT MODEL 73X |
IMPACT INSTRUMENTATION, INC. |
LESLIE H SHERMAN |
| K051461 |
06/03/2005 |
3I OSSEOTITE DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUEYL A HUGHES |
| K051419 |
06/01/2005 |
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 |
INDITHERM MEDICAL |
M.W. (ANDY) ANDERSON |
| K051667 |
06/22/2005 |
EZ-JECT |
INDOLOR, LTD. |
GEORGE J HATTUB |
| K051715 |
06/27/2005 |
STARPACS DENTAL |
INFINITT CO., LTD. |
CARL ALLETTO |
| K051436 |
06/01/2005 |
PRE' VAGINAL LUBRICANT |
INGFERTLITY, LLC |
DENNIS CLIFTON |
| K051742 |
06/28/2005 |
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH |
INNTEC, INC. |
Gary Syring |
| K051450 |
06/02/2005 |
EXTENDED MEASUREMENTS SYSTEM |
INOVISE MEDICAL, INC. |
STEVE C HESLER |
| K051540 |
06/10/2005 |
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR |
INOVO, INC. |
KEVIN CONFOY |
| K051630 |
06/17/2005 |
SUPER VIEW DISPOSABLE BIOM LENS SET |
INSIGHT INSTRUMENTS, INC. |
MICHAEL ANNEN |
| K051717 |
06/27/2005 |
RN SYNOCTA TEMPORARY MESO ABUTMENT |
INSTITUT STRAUMANN SA |
LINDA JALBERT |
| K051440 |
06/02/2005 |
MAYFIELD INFINITY SKULL CLAMP |
INTEGRA LIFESCIENCES CORP. |
DONNA R WALLACE |
| K051512 |
06/07/2005 |
CAC-127-8 CARDOAC ARRAY COIL |
INVIVO CORP. |
THOMAS SCHUBERT |
| K051548 |
06/13/2005 |
IRRADIA MID - LASER (S3) |
IRRADIA AB |
THEO RUSSO-LARSSON |
| K051705 |
06/24/2005 |
IPS E.MAX CAD/IPS E.MAX ZIRCAD |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K051481 |
06/03/2005 |
JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
| K051482 |
06/03/2005 |
JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
| K051454 |
06/02/2005 |
ALEUTIAN SPACER SYSTEM |
K2M, LLC |
RICH WOODS |
| K051531 |
06/09/2005 |
TECTONIC CERVICAL PLATE SYSTEM |
K2M, LLC |
RICH WOODS |
| K051505 |
06/07/2005 |
SCB/STERIS OR-LIGHT INTERFACE BOX |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K051584 |
06/15/2005 |
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY |
KENDALL |
JAMES WELSH |
| K051586 |
06/15/2005 |
VIEWSEND MEDICAL SYSTEM |
KENEI CO., LTD. |
JENNIFER LI |
| K051545 |
06/10/2005 |
L.E. DEMETRON II |
KERR CORPORATION (DANBURY) |
COLLEEN BOSWELL |
| K051611 |
06/17/2005 |
MBARESORB IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
| K051418 |
06/01/2005 |
DIRECT DIGITIZER REGIUS MODEL 370 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI MAMANAKA |
| K051523 |
06/08/2005 |
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K051521 |
06/08/2005 |
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K051552 |
06/13/2005 |
O.A.S.I. SYSTEM |
LANCER ORTHODONTICS, INC. |
GRACE HOLLAND |
| K051608 |
06/17/2005 |
STAR 50 MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K051538 |
06/10/2005 |
AVANTICARE, MODEL SA4022 |
LERADO CHINA LIMITED |
JEFF CHANG |
| K051473 |
06/03/2005 |
LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 |
LERADO CHINA LIMITED |
JEN KE-MIN |
| K051614 |
06/17/2005 |
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS |
LIFECORE BIOMEDICAL, INC. |
RACHEL KENNEDY |
| K051416 |
06/01/2005 |
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA |
MALLINCKRODT MEDICAL |
PATRICK GARVEY |
| K051439 |
06/02/2005 |
LNOP BLUE OXIMETRY SENSOR |
MASIMO CORPORATION |
JAMES J CRONIN |
| K051585 |
06/15/2005 |
F-400 SYSTEM |
MAUNA KEA TECHNOLOGIES |
ALEXANDRE LOISEAU |
| K051676 |
06/23/2005 |
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K051567 |
06/14/2005 |
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K051700 |
06/24/2005 |
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR |
MEDCHANNEL, LLC |
FREDERICK TOBIA |
| K051499 |
06/07/2005 |
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
SALVADORE F PALOMARES |
| K051697 |
06/23/2005 |
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM |
MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP |
C. STEPHEN LAWRENCE |
| K051694 |
06/23/2005 |
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE |
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. |
OYTIP KUNWUNLOP |
| K051421 |
06/01/2005 |
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
| K051488 |
06/06/2005 |
MEDICINELODGE ZIPKNOT |
MEDICINELODGE, INC. |
M. MRY SINNOTT |
| K051422 |
06/01/2005 |
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE |
MEDISIM LTD. |
AHAVA STEIN |
| K051448 |
06/02/2005 |
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) |
MEDOC LTD. ADVANCED MEDICAL SYSTEMS |
GEORGE J HATTUB |
| K051745 |
06/29/2005 |
ECHOSYSTEM |
MEDSTRAT, INC. |
ROBERT J BISHOP |
| K051674 |
06/23/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K051698 |
06/24/2005 |
MERRIES UNI-OSTEO, MODEL CS30250-CS10102 |
MERRIES INTERNATIONAL INC. |
JESSICA LI |
| K051528 |
06/08/2005 |
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE |
MEVIS TECHNOLOGY GMBH & CO. KG |
CARL ALLETTO |
| K051477 |
06/03/2005 |
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) |
MI GWANG CONTACT LENS CO., LTD. |
MARTIN DALSING |
| K051423 |
06/01/2005 |
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MIOK |
| K051425 |
06/01/2005 |
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| K051560 |
06/13/2005 |
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| K051618 |
06/17/2005 |
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 |
MIDWEST R.F. LLC. |
DAVID M PETERSON |
| K051669 |
06/22/2005 |
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
MIGADA PLANT |
YOSSI SHACHAR |
| K051445 |
06/02/2005 |
MILLIKEN SILVER WOUND DRESSINGS |
MILLIKEN CHEMICAL |
MARY MCNAMARA-CULLINANE |
| K051625 |
06/20/2005 |
BARRIER SURGICAL DRAPES |
MOLNLYCKE HEALTH CARE, INC. |
JOHN CLAY |
| K051739 |
06/28/2005 |
POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. |
MULTIGON INDUSTRIES, INC. |
WILLIAM STERN |
| K051596 |
06/16/2005 |
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 |
NANOGEN, INC. |
VAN N SCHRAMM |
| K051765 |
06/30/2005 |
CERETOM, MODEL NL3000 |
NEUROLOGICA CORPORATION |
BRAHIM HADRI |
| K051599 |
06/16/2005 |
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT |
NEURORECOVERY, INC. |
ROSINA ROBINSON |
| K051434 |
06/01/2005 |
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K051740 |
06/28/2005 |
TAPERED COMPRESSION PIN |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K051574 |
06/14/2005 |
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN HADLEY |
| K051486 |
06/06/2005 |
NORWOOD ABBEY CENTURION SES EPIKERATOME |
NORWOOD ABBEY , LTD. |
PAUL CLARK |
| K051617 |
06/17/2005 |
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER |
NovaBone Products, LLC |
DAVID M GAISSER |
| K051607 |
06/17/2005 |
NOVASPINE CEMENT RESTRICTOR NSCR |
NOVASPINE LLC |
HAMID KHOSROWSHAHI |
| K051718 |
06/27/2005 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K051469 |
06/03/2005 |
CAREVENT ATV+ AND CAREVENT MRI |
O-TWO MEDICAL TECHNOLOGIES, INC. |
AMMAR AL-DOJALLY |
| K051541 |
06/10/2005 |
GF-UE160-AL5 ULTRASOUND ENDOSCOPE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K051564 |
06/14/2005 |
OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH |
OLYMPUS AMERICA, INC. |
BEV HARDING |
| K051645 |
06/20/2005 |
EVIS EXERA 160A SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051613 |
06/17/2005 |
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051551 |
06/13/2005 |
SMALL INTESTINAL VIDEOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051753 |
06/29/2005 |
ACCU-SOURCE |
ONCOLOGY SYSTEMS, INC. |
JENNIFER WILLIAMS |
| K051647 |
06/21/2005 |
FORTADERM ANTIMICROBIAL WOUND DRESSING |
ORGANOGENESIS, INC. |
PATRICK BILBO |
| K051751 |
06/29/2005 |
EQUA-PULL SAFETY RELEASE MODULE |
ORTHO TECHNOLOGY |
STEVE KLAMIC |
| K051754 |
06/29/2005 |
ORTHOSCAN, ORTHOSCAN HD |
ORTHOSCAN, INC. |
ARLEN ISSETTE |
| K051576 |
06/14/2005 |
AVANA DENTAL IMPLANT SYSTEM |
OSSTEM CO., LTD. |
ALBERT REGO |
| K051656 |
06/21/2005 |
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER |
| K051664 |
06/22/2005 |
SCAN300FP / RETROPAN (VDC) |
OY AJAT, LTD. |
CLAUDE D BERTHOIN |
| K051465 |
06/03/2005 |
POWDERED LATEX PATIENT EXAMINATION GLOVES |
P.T. ANLIS ABADI INTERNASIONAL |
HUAN-CHUNG LI |
| K051758 |
06/29/2005 |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
PENUMBRA, INC. |
THERESA B BRANDNER-ALLEN |
| K051759 |
06/29/2005 |
FLEXI-LITE, MODEL FL-V1.2 |
PERFORMANCE HYPERBARICS |
SPENCER FELDMAN |
| K051632 |
06/20/2005 |
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K051428 |
06/01/2005 |
VTRAC EXCIMER LAMP SYSTEM |
PHOTO MEDEX, INC. |
BOB ROSE |
| K051464 |
06/03/2005 |
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) |
PLANMECA OY |
BOB PIENKOWSKI |
| K051646 |
06/21/2005 |
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K051691 |
06/23/2005 |
MINIMATE COMPRESSOR |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K051565 |
06/14/2005 |
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA |
PROTON HEALTHCARE LTD. |
Kevin Walls |
| K051566 |
06/14/2005 |
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER |
PROTON HEALTHCARE LTD. |
Kevin Walls |
| K051572 |
06/14/2005 |
KOKO LEGEND |
PULMONARY DATA SERVICES, INC. |
DONALD HENTON |
| K051767 |
06/30/2005 |
LTV 1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K051609 |
06/17/2005 |
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE |
QUILL MEDICAL, INC. |
LOIS V SMART |
| K051743 |
06/29/2005 |
R2 BREAST IMAGING WORKSTATION |
R2 TECHNOLOGY, INC. |
DENISE F GOTTFRIED |
| K051671 |
06/22/2005 |
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K051615 |
06/17/2005 |
STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
| K051468 |
06/03/2005 |
INNER-LOCK INTRODUCER SHEATH |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K051752 |
06/29/2005 |
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) |
Roche Diagnostics |
THERESA M AMBROSE |
| K051517 |
06/08/2005 |
ELECSYS PRECICONTROL ANEMIA |
ROCHE DIAGNOSTICS CORP. |
CORNIA HARPER |
| K051543 |
06/10/2005 |
ELECSYS PRECICONTROL BONE |
ROCHE DIAGNOSTICS CORP. |
CORINA HAPER |
| K051687 |
06/23/2005 |
ELECSYS PRECICONTROL UNIVERSAL |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K051592 |
06/15/2005 |
MODIFICATION TO ACCU-CHEK GO SYSTEM |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K051762 |
06/30/2005 |
SAF-T-SYRINGE/SAF-T-NEEDLE |
SAFETY MEDICAL INTERNATIONAL, INCORPORATED |
DAVID ZARRILLI |
| K051581 |
06/15/2005 |
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K051663 |
06/22/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
| K051699 |
06/24/2005 |
SEJOY, MODEL MT-403 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
JIANYAO WU |
| K051456 |
06/02/2005 |
SENTINEL CERULOPLASMIN |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051444 |
06/02/2005 |
SENTINEL CHOLINESTERASE LIQUID |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051452 |
06/02/2005 |
SENTINEL CLIN CHEM CAL |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051447 |
06/02/2005 |
SENTINEL PANCREATIC AMYLASE |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051457 |
06/02/2005 |
SENTINEL PLASMAPROTEINS CAL 3X |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051683 |
06/23/2005 |
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING |
SHEN WEI (USA), INC. |
STANLEY DUAN |
| K051704 |
06/24/2005 |
MYKRES SPINAL SYSTEM |
SHOWA IKA KOHGYO CO.,LTD. |
FLOYD G LARSON |
| K051736 |
06/28/2005 |
FOX PULSE OXIMETER |
SHUNSUKE NAKANISHI |
YINGCHAO XIAO |
| K051602 |
06/16/2005 |
AXIOM SIRESKOP SD |
SIEMENS MEDICAL SYSTEMS, INC. |
GARY JOHNSON |
| K051510 |
06/07/2005 |
SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K051659 |
06/22/2005 |
SEMIAL SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
| K051661 |
06/22/2005 |
IMPLANT HANDPIECES |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K051605 |
06/16/2005 |
SBI K-WIRES |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
| K051747 |
06/29/2005 |
SBI WRISTFIT |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
| K051735 |
06/28/2005 |
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K051557 |
06/13/2005 |
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K051524 |
06/08/2005 |
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
| K051568 |
06/14/2005 |
CADD-MS 3 AMBULATORY INFUSION PUMP |
SMITHS MEDICAL MD, INC. |
MELANIE HESS |
| K051426 |
06/01/2005 |
CARLO SURGICAL GOWN |
SOFILM TECHNOLOGY CO., LTD. |
JEFFRY O STULL |
| K051503 |
06/07/2005 |
UGYTEX SUAL KNIT MESH |
SOFRADIM PRODUCTION |
PAMELA PAPINEAU |
| K051631 |
06/20/2005 |
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 |
STARGATE INTERNATIONAL, INC. |
ROBERT H WALKER |
| K051760 |
06/29/2005 |
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 |
STEREOTAXIS, INC. |
PETER A TAKES |
| K051506 |
06/07/2005 |
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY |
STERYLAB S.R.L. |
PAUL E DRYDEN |
| K051633 |
06/20/2005 |
CD-CHEX PLUS BC |
Streck |
CAROL THOMPSON |
| K051706 |
06/27/2005 |
IQ BODY FLUIDS CONTROL |
Streck |
MARK LEWALLEN |
| K051603 |
06/15/2005 |
STRYKER INJECTABLE CEMENT |
STRYKER LEIBINGER MICRO IMPLANTS |
WADE T RUTKOSKIE |
| K051741 |
06/28/2005 |
ACCOLADE HFX FEMORAL STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K051474 |
06/03/2005 |
SYMBIOS DISPOSABLE INFUSION PUMP KIT |
SYMBIOS MEDICAL PRODUCTS, LLC |
JEFFERY J ALHOLM |
| K051720 |
06/27/2005 |
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE |
SYNTHES (USA) |
KATHY ANDERSON |
| K051600 |
06/16/2005 |
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM |
SYNTHES (USA) |
KATHY ANDERSON |
| K051678 |
06/23/2005 |
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K051665 |
06/22/2005 |
SYNTHES VECTRA-T SYSTEM |
SYNTHES SPINE |
SUSAN LEWANDOWSKI |
| K051459 |
06/02/2005 |
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K051703 |
06/24/2005 |
CLEVER TD-3018A BLOOD PRESSURE MONITOR |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K051526 |
06/08/2005 |
URITEK-720+ URINE ANALYZER |
TECO DIAGNOSTICS |
STEPHANIE LOW |
| K051766 |
06/30/2005 |
ORTHOMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K051562 |
06/13/2005 |
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K051563 |
06/13/2005 |
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K051601 |
06/16/2005 |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K051710 |
06/27/2005 |
THERMAGE THERMACOOL COUPLING FLUID |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K051502 |
06/07/2005 |
SPI DENTAL IMPLANT |
THOMMEN MEDICAL, AG |
Floyd Larson |
| K051527 |
06/08/2005 |
SPI EASY TEMPORARY CAP |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K051583 |
06/15/2005 |
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
| K051500 |
06/07/2005 |
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K051763 |
06/30/2005 |
QD KNEE/FOOT COIL, MODEL MJQJ-147A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K051547 |
06/13/2005 |
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 |
TPC ADVANCED TECHNOLOGY, INC. |
SCOTT BECKLEY |
| K051587 |
06/15/2005 |
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 |
TRACOE MEDICAL GMBH |
MICHAEL A WARREN |
| K051688 |
06/23/2005 |
FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS |
TRIMENSA PHARMACEUTICALS |
ROBIN J OGILVIE |
| K051542 |
06/10/2005 |
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING |
TRIOSYN CORP. |
KYLE ANDERSON |
| K051595 |
06/16/2005 |
TSO3 OZONE STERILIZER, MODEL 125L |
TSO3 INC. |
CHARLES O HANCOCK |
| K051651 |
06/21/2005 |
G4, MODEL IGM-0004 |
U. S. DIAGNOSTICS, INC. |
EDWARD LETKO |
| K051750 |
06/29/2005 |
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
| K051638 |
06/20/2005 |
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC |
UNIPATH LTD. |
Louise Roberts |
| K051640 |
06/20/2005 |
U2 TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| K051637 |
06/20/2005 |
DSNARE, MODEL 00711087 |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
| K051644 |
06/20/2005 |
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR |
VALLEYLAB |
HERBERT VINSON |
| K051627 |
06/20/2005 |
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT |
VALLEYLAB |
HERBERT VINSON |
| K051616 |
06/17/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K051497 |
06/06/2005 |
VITESSE 2.0 |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K051716 |
06/27/2005 |
VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K051709 |
06/27/2005 |
HIPPOCAMPE WHEELCHAIR |
VIPAMAT TECHNOLOGIE |
MARY MCNAMARA-CULLINANE |
| K051559 |
06/13/2005 |
IMASK, MODELS 100, 200 AND 300 |
VITAL SIGNS COLORADO, INC. |
TOM DIELMANN |
| K051535 |
06/10/2005 |
MODIFICATION TO:REGISTRADO X-TRA |
VOCO GMBH |
GERALD W SHIPPS |
| K051690 |
06/23/2005 |
VYGON NUTRILINE CATHETERS |
VYGON CORP. |
COURTNEY SMITH |
| K051539 |
06/10/2005 |
TRICOT BLOOD PRESSURE CUFF |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K051484 |
06/06/2005 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
MARK K KOPNITSKY |
| K051424 |
06/01/2005 |
HYDROGUM 5 |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K051723 |
06/27/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) |
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K051623 |
06/20/2005 |
ANATOMICAL SHOULDER KEELED GLENOID |
ZIMMER GMBH |
BRANDON HIPSHER |
| K051756 |
06/29/2005 |
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K051491 |
06/06/2005 |
TRABECULAR METAL PRIMARY HIP PROSTHESIS |
ZIMMER, INC. |
DALENE T BINKLEY |
| K051516 |
06/08/2005 |
TRABECULAR METAL REVISION SHELL LINERS |
ZIMMER, INC. |
TONY KINGSLEY |
| K051475 |
06/03/2005 |
ZOLL M SERIES 12SL ANALYSIS OPTION |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
