FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K053438 |
01/18/2006 |
GLASS CERAMICS |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
K062493 |
11/17/2006 |
LAVA SOFTWARE |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
K062855 |
11/22/2006 |
CALCIUM |
ABBOTT LABORATORIES |
LINDA MORRIS |
K052566 |
01/06/2006 |
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
K060020 |
01/20/2006 |
AUTOQUANT PLUS |
ADAC LABORATORIES |
COLEEN A COLEMAN |
K063173 |
11/03/2006 |
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
GRAHAME SOMERVILLE |
K062135 |
11/07/2006 |
ART SHIELDED BREAST APPLICATOR |
ADVANCED RADIATION THERAPY, LLC |
RAYMOND J BRICAULT |
K062510 |
11/17/2006 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP |
MATTHEW M HULL |
K062413 |
11/21/2006 |
AESCULAP PNEUMATIC KERRISON |
AESCULAP, INC. |
KATHY A RACOSKY |
K062684 |
11/22/2006 |
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD |
AESCULAP, INC. |
KATHY A RACOSKY |
K053526 |
01/18/2006 |
MICROSPEED UNI MOTOR SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
K053158 |
01/18/2006 |
OPTILENE MESH LP |
AESCULAP, INC. |
MATTHEW M HULL |
K052825 |
01/20/2006 |
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
K051028 |
01/27/2006 |
BREEZE |
AFIKIM ELECTRIC VEHICLES |
AVNER FISHBEIN |
K062434 |
11/13/2006 |
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 |
AGAMATRIX |
CONNIE HERTEL |
K052762 |
01/23/2006 |
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 |
AGAMATRIX INC |
CONNIE HERTEL |
K063421 |
11/22/2006 |
DX-SI |
AGFA CORP. |
JEFFERY A JEDLICKA |
K053634 |
01/17/2006 |
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION |
AGFA CORPORATION |
JEFFERY A JEDLICKA |
K052697 |
01/04/2006 |
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
K062930 |
11/08/2006 |
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM |
ALCON RESEARCH, LTD. |
JANET G JOHNSON |
K052918 |
01/27/2006 |
REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K060059 |
01/13/2006 |
ALOKA SD-3500 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
K051031 |
01/06/2006 |
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS |
AMERIWATER |
BRIAN R BOWMAN |
K052548 |
01/06/2006 |
UROK ROCKING WHEELCHAIR, MODEL 700-4XX |
AMG MEDICAL INC. |
KENNETH LEVESQUE |
K062212 |
11/21/2006 |
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S |
ANACAPA TECHNOLOGIES, INC. |
ILA DOSHI |
K060096 |
01/24/2006 |
MODULAR TROCAR SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K060051 |
01/19/2006 |
SPECIMEN RETRIEVAL SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K051648 |
01/31/2006 |
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
K062466 |
11/29/2006 |
ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
ANN WATERHOUSE |
K053338 |
01/26/2006 |
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS |
ARTHREX, INC. |
ANN WATERHOUSE |
K053180 |
01/25/2006 |
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K052830 |
01/19/2006 |
SPORTMESH |
ARTIMPLANT AB |
TERRY SHERIDAN POWELL |
K061601 |
11/17/2006 |
ASAHI PRECIOUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K062186 |
11/09/2006 |
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K052666 |
01/25/2006 |
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN |
ASCEND EAGLE, INC. |
JARILYN LIM |
K062467 |
11/22/2006 |
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
ERICA CONWAY |
K061639 |
11/01/2006 |
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
K052773 |
01/24/2006 |
B. BRAUN 0.2 MICRON FILTER |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
K063280 |
11/17/2006 |
INJEKT SYRINGE |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
K062715 |
11/03/2006 |
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY A DOUCETTE |
K062131 |
11/17/2006 |
NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB |
BARCOVIEW |
LIEVEN DE WANDEL |
K053501 |
01/13/2006 |
POWERPICC |
BARD ACCESS SYSTEMS, INC. |
LYNN M KIRCHOFF |
K062441 |
11/14/2006 |
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 |
BARRX MEDICAL, INCORPORATED |
JONATHAN S KAHAN |
K062723 |
11/09/2006 |
HALO90 COAGULATION CATHETER |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
K053124 |
01/30/2006 |
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
BAUSCH & LOMB INCORPORATED |
LISA GRANEY |
K062347 |
11/22/2006 |
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
MARC HENN |
K062944 |
11/15/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K062945 |
11/21/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
K062044 |
11/21/2006 |
THE 5.0 X 6.0MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
K062109 |
11/09/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
Angela Drysdale |
K060001 |
01/20/2006 |
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
K061567 |
11/22/2006 |
BIOHORIZONS CERAMIC ABUTMENT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
K060027 |
01/26/2006 |
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) |
BIOKIT S.A. |
JOAN GUIXER |
K060050 |
01/23/2006 |
MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC, INC. |
JONATHAN S KAHAN |
K051774 |
01/20/2006 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
K061794 |
11/21/2006 |
FIDIS TM THYRO, MODEL MX002 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
CHRISTELLE COURIVAUD |
K053004 |
01/13/2006 |
MSAS-VANTAGE |
BIOMERIDIAN, INT. |
GENE SWIFT |
K053299 |
01/05/2006 |
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT |
BIOMET MANUFACTURING, INC. |
PATRICIA S BERES |
K053327 |
01/26/2006 |
OXICOM CONTROL |
BIONOSTICS, INC. |
KATHLEEN STORRO |
K062980 |
11/22/2006 |
ACTIVASCREW |
BIORETEC LTD |
MARI RUOTSALAINEN |
K052789 |
01/23/2006 |
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 |
BIOSITE INCORPORATED |
RACHAEL S WILLIAMSON |
K052742 |
11/07/2006 |
HEPASPHERE MICROSPHERES |
BIOSPHERE MEDICAL, INC. |
ROSINA ROBINSON |
K063060 |
11/29/2006 |
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP |
BLUESHINE SRL |
ALICE NOVELLI |
K052964 |
01/06/2006 |
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN |
BOSTON SCIENTIFIC CORP. |
KATIE GERBENSKY |
K063312 |
11/30/2006 |
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
K051880 |
01/04/2006 |
RIO ASPIRATION CATHETER |
BOSTON SCIENTIFIC CORP. |
CATHERINE A PETERS |
K060078 |
01/31/2006 |
FIBERED IDC OCCLUSION SYSTEM |
Boston Scientific Corporation |
CHRISTINE M CAMERON |
K060006 |
01/31/2006 |
BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER |
BRAUN GMBH |
FRED SCHLADOR |
K053065 |
01/03/2006 |
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) |
BRYAN KEROPIAN DDS |
BRYAN KEROPIAN |
K063178 |
11/21/2006 |
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 |
C.R. BARD, INC. |
STEPHANIE BAKER |
K063240 |
11/21/2006 |
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K061705 |
11/21/2006 |
CADWELL EASYNET NASAL PRESSURE MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
K053221 |
01/12/2006 |
CDMX-H |
CAMSIGHT CO., INC. |
JAY CHOI |
K062886 |
11/06/2006 |
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 |
CAO GROUP, INC. |
ROBERT K LARSEN |
K062619 |
11/14/2006 |
DENLASER 800 PLUS |
CAO GROUP, INC. |
ROBERT K LARSEN |
K063193 |
11/21/2006 |
MODIFICATION TO BIOMARC TISSUE MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
K052556 |
01/09/2006 |
CG-7000DX-BT ECG RECORDER/TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K052570 |
01/17/2006 |
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 |
CARDIAC ASSIST, INC. |
TIM KRAUSKOPF |
K052316 |
01/03/2006 |
POWERHEART ECD |
CARDIAC SCIENCE, INC. |
KENNETH OLSON |
K053062 |
01/06/2006 |
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 |
CARDIARC LTD. |
JONATHAN KAHN |
K053524 |
11/16/2006 |
C-PORT DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
DAVID CASAL |
K053272 |
01/05/2006 |
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES |
Cardinal Health |
AMY HOYD |
K063288 |
11/28/2006 |
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
K053049 |
01/12/2006 |
ALARIS SAFETY MALE LUER |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
K062340 |
11/30/2006 |
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM |
CARDIO-OPTICS, INC. |
LARRY BLANKENSHIP |
K063222 |
11/14/2006 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 |
CARDIONET, INC |
JACK GAIKWAD |
K052295 |
01/13/2006 |
CARDIOSOFT PC ECG, USB VERSION |
CARDIOSOFT, L.P. |
S. MORADI |
K062400 |
11/16/2006 |
IMPRESSIX, COLORCHANGE ALGINATE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K062487 |
11/17/2006 |
APERFIX FEMORAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
Floyd Larson |
K063289 |
11/16/2006 |
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
K063266 |
11/09/2006 |
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
K063291 |
11/21/2006 |
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 |
CHOICE SMART HEALTH CARE CO. LTD. |
JANICE MA |
K053324 |
01/05/2006 |
CHROMOLITE SYSTEM |
CHROMOGENEX PLC |
CHRIS WILLIAMS |
K062262 |
11/14/2006 |
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
K063079 |
11/07/2006 |
I-STOP TRANS OBTURATOR MALE SLING |
CL MEDICAL |
VINCENT GORIA |
K053379 |
01/25/2006 |
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE |
CLASSONE ORTHODONTICS, INC. |
JUDY RIBORDY |
K053156 |
01/31/2006 |
MINI-WRIGHT DIGITAL, MODEL 3120001 |
CLEMENT CLARKE INTL., LTD. |
PHILIP HALLYBONE |
K051435 |
01/19/2006 |
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 |
CLINICAL MICRO SENSORS |
WILLIAM A COTY |
K053107 |
01/19/2006 |
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD |
Codman & Shurtleff, Inc. |
SUSAN KAGAN |
K053350 |
01/19/2006 |
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS |
Codman & Shurtleff, Inc. |
BRIAN KANERVIKO |
K052812 |
01/25/2006 |
OSSIMEND (TM) BONE GRAFT MATERIAL |
COLLAGEN MATRIX, INC. |
PEGGY C HANSEN |
K052820 |
01/09/2006 |
PARAPOST PARACORE AUTOMIX 5ML |
COLTENE/WHALEDENT AG |
H. J. VOGELSTEIN |
K062593 |
11/22/2006 |
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET |
COMPASS BIOSCIENCE |
CARTER GRANDJEAN |
K061814 |
11/30/2006 |
VASOPRESS DVT SYSTEM, MODEL VP500D |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
K062548 |
11/01/2006 |
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
MARTIN DALSING |
K063252 |
11/14/2006 |
ATB ADVANCED PTA DILATATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
K061948 |
11/22/2006 |
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS |
COOPERVISION, INC. |
LISA HAHN |
K060987 |
11/02/2006 |
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 |
CP MEDICAL |
BETSY CORTELLONI |
K051145 |
01/18/2006 |
CRITIVIEW |
CRITISENSE LTD. |
PAUL E DRYDEN |
K053436 |
01/13/2006 |
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
K061892 |
11/22/2006 |
PROPATCH SOFT TISSUE REPAIR MATRIX |
CRYOLIFE, INC. |
JOHN D FERROS |
K063102 |
11/09/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K063099 |
11/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) |
DADE BEHRING, INC. |
MAY MORISHIMA |
K063101 |
11/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML |
DADE BEHRING, INC. |
MAUREEN MENDE |
K063299 |
11/27/2006 |
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN |
DADE BEHRING, INC. |
MAY MORISHIMA |
K062938 |
11/20/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K052534 |
01/27/2006 |
TACAHE |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K062754 |
11/02/2006 |
GAS MODULE SE, MODEL 0998-00-0481-02 |
DATASCOPE CORP. |
KATHLEEN KRAMER |
K062469 |
11/03/2006 |
VOYAGER 12 |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
K063188 |
11/30/2006 |
DEL-IMS |
DEL MEDICAL IMAGING CORP. |
WILLIAM J ENGEL |
K062733 |
11/09/2006 |
TOMAS PIN SD 6, 8, AND 10 MM |
DENTAURUM |
CHARLES R BELL |
K062828 |
11/27/2006 |
MOUTHGUARD AND ALIGNER MATERIALS |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K063273 |
11/22/2006 |
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR |
DEPUY MILTEK, A JOHNSON & JOHNSON CO. |
KRISTINE CHRISTO |
K060031 |
01/31/2006 |
DEPUY MODULAR M HEADS |
DEPUY ORTHOPAEDICS, INC. |
KELI K HANKEE |
K062748 |
11/30/2006 |
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K053445 |
01/06/2006 |
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K062174 |
11/02/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
MARY GRAY |
K063156 |
11/22/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
K061101 |
11/20/2006 |
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
K063067 |
11/03/2006 |
CONFIDENCE FENESTRATED INTRODUCER NEEDLE |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
K063146 |
11/27/2006 |
ACCU-CHEK LINKASSIST |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
K052649 |
01/27/2006 |
DRG SLV TESTOSTERONE ELISA TEST |
DRG INTL., INC. |
Gary Lehnus |
K053176 |
01/30/2006 |
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
K053285 |
01/05/2006 |
MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM |
DURTECH SYSTEM CORP. |
ADA LIN |
K063029 |
11/02/2006 |
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 |
E-Z-EM, INC. |
TRACEY CAMPBELL |
K053347 |
01/04/2006 |
KODAK CARESTREAM PACS |
EASTMAN KODAK COMPANY |
CAROLYN L WAGNER |
K053606 |
01/24/2006 |
BE PLUS / AURA-LTM64 AMPLIFIER |
EB NEURO, S.P.A. |
CARRI GRAHAM |
K061696 |
11/13/2006 |
IQQA-LIVER SOFTWARE |
EDDA TECHNOLOGY, INC. |
XIAOLAN ZENG |
K063120 |
11/09/2006 |
COLOR LCD MONITOR, RADIFORCE, MODEL RX210 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K053437 |
01/06/2006 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K062507 |
11/22/2006 |
MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K063448 |
11/30/2006 |
EMG AC/DC SUCTION UNIT |
EMG TECHNOLOGY CO., LTD. |
SALLY CHUANG |
K052438 |
01/31/2006 |
EMG HANDLE NEBULIZER NB02 SERIES |
EMG TECHNOLOGY CO., LTD. |
GENE R KULON |
K053455 |
01/25/2006 |
ENCOMPASS.NET |
EMPIRIC SYSTEMS, LLC |
CARL ALLETTO |
K063257 |
11/22/2006 |
FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K053267 |
01/13/2006 |
ENDIUS ATAVI SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
K053326 |
01/06/2006 |
ESTECH COBRA ELECTROSURGICAL UNIT & CABLE |
ENDOSCOPIC TECHNOLOGIES, INC. |
CRAIG COOMBS |
K052479 |
01/26/2006 |
MBATH 1000 (60) |
ENNEKING MEDICAL INC. |
STEPHEN WHITTENBURG |
K063277 |
11/30/2006 |
MAPMATE |
EP MEDSYSTEMS, INC. |
LARRY PICCIANO |
K063207 |
11/09/2006 |
S-SCAN MRI SYSTEM |
ESAOTE, S.P.A. |
CARRI GRAHAM |
K053557 |
01/20/2006 |
ESKA-LIBUR HIP STEM |
ESKA IMPLANTS GMBH & CO. |
J. D WEBB |
K053021 |
01/26/2006 |
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR |
ESTECH, INC. |
CRAIG COOMBS |
K053631 |
01/30/2006 |
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET |
ETHICON ENDO-SURGERY, INC. |
WENDY TURNER |
K053056 |
01/19/2006 |
HARMONIC SCALPEL BLADES AND SHEARS |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
K063204 |
11/14/2006 |
SPIDERFX EMBOLIC PROTECTION DEVICE |
EV3 INC |
David Worrell |
K052453 |
01/13/2006 |
TRACTION SYSTEM, DIGIT-TRAC 930 |
EVER PROSPEROUS INSTRUMENT, INC. |
KE-MEN JEN |
K053427 |
01/13/2006 |
FRESH, DENTAL IMPRESSION MATERIAL |
EXACTA DENTAL PRODUCTS, INC. |
RICHARD KEEN |
K063279 |
11/29/2006 |
NOVATION SPLINED RDD FEMORAL STEMS |
EXACTECH, INC. |
MARITZA ELIAS |
K052642 |
01/17/2006 |
SUTURING WASHER |
FIRST CALL, INC. |
DINA L WEISSMAN |
K053460 |
01/13/2006 |
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, |
FOX HOLLOW TECHNOLOGIES |
MELISSA MURPHY |
K052813 |
01/25/2006 |
FD TENS 2030, MODEL DFJ24T |
FUJI DYNAMICS LIMITED |
ANTHONY AH YIN SHUN |
K051163 |
01/31/2006 |
GALIX ECG PROFESSIONAL STATION |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
GREG VELEZ |
K051400 |
01/20/2006 |
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS |
GE HEALTHCARE |
JOEL C KENT |
K052976 |
01/13/2006 |
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
K052975 |
01/20/2006 |
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
K062440 |
11/07/2006 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 |
GEN-PROBE, INC. |
E JOSEPH MCMULLEN |
K063006 |
11/02/2006 |
GE LOGIQ WORKS |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K053559 |
01/20/2006 |
PF4 ENHANCED SOLID PHASE ELISA |
GENETIC TESTING INSTITUTE |
LEIGH ANN TIDEY |
K063162 |
11/02/2006 |
GOLDEN LITEWAY |
GOLDEN TECHNOLOGIES, INC. |
GENE R KULON |
K052955 |
01/19/2006 |
NITRILE BLUE POWDERED EXAMINATION GLOVES |
GREAT GLOVE SDN BHD |
LIM WEE-CHAI |
K062721 |
11/21/2006 |
GREENTON ECOLITE IPL SYSTEM |
GREENTON (LONDON) LTD. |
ROBERT T HANDREN |
K061933 |
11/16/2006 |
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER |
HAGER WORLDWIDE, INC. |
JAMES DELANEY |
K052863 |
01/06/2006 |
RAPHAEL COLOR |
HAMILTON MEDICAL AG |
CURDIN DANUSER |
K063046 |
11/17/2006 |
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) |
HARTALEGA SDN BHD |
NURUL A KONG |
K052925 |
01/04/2006 |
SMARTPREP2 CENTRIFUGE SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
JOHN D BONASERA |
K052935 |
01/13/2006 |
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) |
HEIDELBERG ENGINEERING |
GERHARD ZINSER |
K052723 |
01/13/2006 |
SEVEN STAR NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
K062515 |
11/22/2006 |
RETENTION FLOW OPAQUE |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
K061993 |
11/03/2006 |
EQUIVITAL, MODEL EQ-01 |
HIDALGO LIMITED |
JUSTIN PISANI |
K051677 |
01/23/2006 |
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
EMI ZYCHLINSKY |
K061608 |
11/22/2006 |
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
K053309 |
01/24/2006 |
ALTAIRE INTERVENTIONAL MR PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K053486 |
01/04/2006 |
TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET |
HOFFRICHTER GMBH |
STEPHEN H GORSKI |
K062999 |
11/03/2006 |
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN |
HOSPIRA, INC. |
DIANE RENNPFERD |
K053472 |
01/11/2006 |
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
K053198 |
01/26/2006 |
SIMPLEX P SPEEDSET BONE CEMENT |
HOWMEDICA OSTEONICS CORP |
TIFFANI D ROGERS |
K062419 |
11/15/2006 |
TRIDENT LARGE DIAMETER ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
K061848 |
11/08/2006 |
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 |
HYPERMED, INC. |
CHAS BURR |
K063234 |
11/21/2006 |
ON-Q INTRODUCERS |
I-FLOW CORP. |
SHANE NOEHRE |
K053110 |
01/13/2006 |
I-STAT CHEM8 + CARTRIDGE |
I-STAT CORPORATION |
PAUL VANDERWERF |
K053106 |
01/10/2006 |
TEGO, MODEL D1000 |
ICU MEDICAL, INC. |
DALE FAIRCHILD |
K052577 |
01/24/2006 |
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM |
IKONISYS INC |
S. MICHAEL SHARP |
K063246 |
11/22/2006 |
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K063247 |
11/22/2006 |
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K063039 |
11/02/2006 |
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K062985 |
11/22/2006 |
IVUS ENHANCER |
INDEC SYSTEMS, INC. |
CAROL HUBLER |
K062782 |
11/09/2006 |
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 |
INION OY |
KATI MARTTINEN |
K052951 |
01/27/2006 |
ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD HOLSTEIN |
K053242 |
01/06/2006 |
PITT-EASY DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD HOLSTEIN |
K061718 |
11/13/2006 |
INNOVACON SPECTRUM II TEST CARD |
INNOVACON, INC. |
EDWARD TUNG |
K063422 |
11/21/2006 |
BIOAGGREGATE |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
K062589 |
11/30/2006 |
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM |
INOLASE 2002, LTD. |
GEORGE J HATTUB |
K053499 |
01/13/2006 |
HEMOSIL PROS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K053462 |
01/18/2006 |
3160 MRI PATIENT MONITORING SYSTEM |
INVIVO CORPORATION |
NEIL BATTISTE |
K053641 |
01/24/2006 |
IBA PROTON THERAPY SYSTEM-PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
K062369 |
11/08/2006 |
IRIDEX OCULIGHT TX |
IRIDEX CORP. |
JOHN JOSSY |
K062074 |
11/14/2006 |
IRIDEX WIRELESS FOOTSWITCH |
IRIDEX CORP. |
JOHN JOSSY |
K062384 |
11/09/2006 |
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE |
ISORAY, INC |
DAVID J SWANBERG |
K062713 |
11/02/2006 |
ADHESIVE DC ACTIVATOR |
IVOCLAR VIVADENT, INC. |
ANDERJEET S GULATI |
K053220 |
01/06/2006 |
VERAVIEW IC 5, MODEL XDP1 |
J. MORITA USA, INC. |
KEITH A BARRITT |
K062740 |
11/02/2006 |
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU |
JINDELL MEDICAL INSTRUMENTS CO., LTD. |
Ke-Min Jen |
K062614 |
11/01/2006 |
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) |
JOHNSON & JOHNSON VISION CARE, INC. |
SUSAN MORRIS |
K050384 |
01/13/2006 |
KAPP BARI-RING, MODEL KS-BR-2005 |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
K052680 |
01/23/2006 |
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
K060907 |
11/09/2006 |
KARL STORZ VIDEO GASTROSCOPES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
K062412 |
11/06/2006 |
CRYOMATIC |
KEELER INSTRUMENTS, INC. |
EUGENE R VANARSDALE |
K062671 |
11/03/2006 |
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) |
KENDALL |
KEITH MARTIN |
K053410 |
01/06/2006 |
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR |
KENDALL |
JIM WELSH |
K061749 |
11/22/2006 |
ECLIPSE TOTAL ANKLE IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G STAMPINATO |
K062857 |
11/22/2006 |
KLS MARTIN QUICK DISC |
KLS MARTIN L.P. |
JENNIFER DAMATO |
K060026 |
01/26/2006 |
KOBY SURGICAL INTERNAL FIXATION SYSTEM |
KOBY SURGICAL |
PERRY FORRESTER |
K051847 |
01/05/2006 |
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
K062021 |
11/01/2006 |
KOWA VX-10I |
KOWA CO. LTD. |
RICHARD PHILLIPS |
K062409 |
11/08/2006 |
K-ETCHANT GEL |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K063031 |
11/02/2006 |
PRISM VIEW, MODEL |
KYRON CLINICAL IMAGING, INC. |
JAMES L REUSS, PH.D. |
K060058 |
01/20/2006 |
STELLAR 404T |
LARSEN & TOUBRO LIMITED |
HARRY GUGNANI |
K063161 |
11/21/2006 |
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
K053630 |
01/26/2006 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
FARZAD PARSALE |
K062643 |
11/16/2006 |
KINETIC ANTERIOR CERVICAL PLATE |
LIFE SPINE |
ERIN MALLOY |
K062876 |
11/01/2006 |
PRIMACONNEX CERAMIC ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
BRIAN SMEKAL |
K053643 |
01/23/2006 |
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 |
LIFECORE BIOMEDICAL, INC. |
BRIAN SMEKAL |
K053529 |
01/17/2006 |
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
LISA MCGRATH |
K062571 |
11/21/2006 |
LONGPORT EPISCAN, MODEL-I-200 |
LONGPORT, INC. |
MICHAEL G FARROW |
K061375 |
11/17/2006 |
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 |
LOUIS M. GERSON CO., INC. |
ROBERT BRUNELL |
K053225 |
11/06/2006 |
CELLU M6 KEYMODULE I |
LPG ONE, INC |
JAY MANSOUR |
K062871 |
11/14/2006 |
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE |
LYNTON LASERS LIMITED |
ANDREW J BERRY |
K050263 |
11/21/2006 |
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU |
M.O.C.O.M. SRL |
DANIELE TOSI |
K053247 |
01/13/2006 |
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
K052119 |
01/03/2006 |
TESLAGUARD, MODEL EFT G04 |
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH |
ROBERT N CLARK |
K063333 |
11/21/2006 |
M3 |
MAVIG GMBH |
CHRISTIAN STOIAN |
K062474 |
11/09/2006 |
SMITHWICK CAROTID SHUNT |
MCPHERSON ENTERPRISES, INC. |
WILLIAM MCPHERSON |
K061905 |
11/08/2006 |
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 |
MEDCON LTD. |
JONATHAN S KAHAN |
K062127 |
11/08/2006 |
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
K062662 |
11/21/2006 |
TELEMEDICINE SYSTEM MODEL VMS-01 |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
K053518 |
01/26/2006 |
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
K053227 |
01/13/2006 |
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
MIKE ALCALA |
K062746 |
11/20/2006 |
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 |
MEDICON HELLAS S.A. |
GEORGE PSICHAS |
K053235 |
01/24/2006 |
NSK PRECISION APEX LOCATOR (PAL) |
MEDICSENSE U.S.A. |
George Hattub |
K062482 |
11/03/2006 |
VENTED VIAL ADAPTER TRANSFER DEVICE |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
K060087 |
01/24/2006 |
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
K053530 |
01/03/2006 |
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
K062984 |
11/13/2006 |
MEDLINE HYPODERMIC NEEDLES |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K053574 |
01/25/2006 |
MEDLINE PEDIATRIC WHEELCHAIRS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K061316 |
11/02/2006 |
MEDLINE SURGICAL SPONGE SCANNER |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K052357 |
01/19/2006 |
PATHWAY - ATS/CHEPS |
MEDOC LTD. ADVANCED MEDICAL SYSTEMS |
GEORGE J HATTUB |
K063342 |
11/30/2006 |
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS |
MEDRAD, INC. |
LISA A EWING |
K052854 |
01/20/2006 |
LIFENET EXCHANGE SYSTEM |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
TERESA DAVIDSON |
K052970 |
01/11/2006 |
SIMPLICI-T ANNULOPLASTY SYSTEM |
MEDTRONIC HEART VALVES |
PHIL NEURURER |
K053177 |
01/31/2006 |
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E |
MEDTRONIC MINIMED |
STACI ELLIS |
K063117 |
11/03/2006 |
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX |
MEDTRONIC NEUROSURGERY |
JEFFERY HENDERSON |
K053101 |
01/05/2006 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K053474 |
01/06/2006 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K053483 |
01/05/2006 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K063083 |
11/06/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD S CHIN |
K062807 |
11/06/2006 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD CHIN |
K052459 |
01/11/2006 |
6248VAL ADJUSTABLE VALVE |
MEDTRONIC VASCULAR |
MICHELLE NIVALA |
K063305 |
11/29/2006 |
STIMULATING BUR GUARD |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
K053185 |
01/24/2006 |
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM |
MEDWAVE, INC. |
DONNA R LUNAK |
K052369 |
01/10/2006 |
EXFEEL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
DAE KYU CHANG |
K063327 |
11/22/2006 |
ORTHOVIEW |
MERDIAN TECHNIQUE, LTD. |
ANTHONY THORNE |
K053171 |
01/19/2006 |
MERIT IMPRESS DIAGNOSTIC CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE ERSKINE |
K062906 |
11/17/2006 |
ENA HFO COMPOSITE SYSTEM |
MICERIUM S.P.A. |
EUGENIO MICELI |
K051990 |
01/04/2006 |
ECHELON MICRO CATHETER |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
K052919 |
01/13/2006 |
MICROSULIS TISSUE ABLATION SYSTEM |
MICROSULIS AMERICAS, INC. |
TIMOTHY Y COWART |
K052485 |
01/17/2006 |
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF |
MIDI, INC. |
WILLIAM STIMSON |
K053086 |
01/27/2006 |
MIE - GAMMA CAMERA SYSTEMS |
MIE AMERICA, INC. |
KAY WARREN |
K050952 |
01/31/2006 |
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR |
MINNTECH CORP. |
LYNN LUEDERS |
K042096 |
01/26/2006 |
MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
K062153 |
11/21/2006 |
PORTABLE OXYGEN GENERATOR SYSTEM |
MOLECULAR PRODUCTS LTD. |
PAUL DRYDEN |
K062677 |
11/15/2006 |
ELI 350 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
HARLAN VAN MATRE |
K042829 |
01/13/2006 |
DBX STRIP |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
KAREN HARDWICK |
K042504 |
01/19/2006 |
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
K051271 |
01/10/2006 |
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR |
NELLCOR PURITAN BENNETT, INC. |
JAMES P GARVEY |
K052930 |
01/31/2006 |
NAVIGATOR ENDOSCOPY SYSTEM |
NEOGUIDE SYSTEMS, INC. |
MICHAEL A DANIEL |
K052878 |
01/23/2006 |
NT-1000 |
NEUROTHERM, INC. |
WILLIAM RITTMAN |
K061829 |
11/17/2006 |
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
NEW LEAF MEDICAL, INC. |
RICHARD T NOCK |
K053502 |
01/10/2006 |
NEWPORT E360 VENTILATOR |
NEWPORT MEDICAL INSTRUMENTS, INC. |
RICHARD WATERS |
K060071 |
01/26/2006 |
NEXA COMPRESSION SCREW |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
K053029 |
01/06/2006 |
NDR+/DIVA-D |
NICAL SPA |
GERALD SILVERMAN |
K053091 |
01/27/2006 |
PROCERA IMPLANT BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K062749 |
11/29/2006 |
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM |
NOBEL BIOCARE AB |
HERBERT CRANE |
K053130 |
01/11/2006 |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
NONIN MEDICAL, INC. |
LORI M ROTH |
K062241 |
11/09/2006 |
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR |
NORTH AMERICAN SCIENTIFIC, INC. |
LEIGH SPOTTEN |
K061830 |
11/01/2006 |
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K062500 |
11/21/2006 |
FLEXPEN NEEDLE |
NOVO NORDISK INC. |
RICK SPRING |
K062581 |
11/29/2006 |
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
OLYMPUS AMERICA, INC. |
DAVID DAVIS |
K063141 |
11/29/2006 |
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
K062043 |
11/07/2006 |
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
K060054 |
11/21/2006 |
ONCOBIONIC SYSTEM |
ONCOBIONICS, INC. |
LAURIE A CLARKE |
K063177 |
11/30/2006 |
RAPID STRAND RX |
ONCURA INC. |
SUBHASH PATEL |
K062416 |
11/17/2006 |
RETINAL FUNCTIONAL IMAGER (RFI) |
OPTICAL IMAGING LTD. |
JONATHAN S KAHAN |
K053044 |
01/24/2006 |
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 |
OPTO GLOBAL, INC |
MARK T FUKUHARA |
K063144 |
11/13/2006 |
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
SARAH C PARSONS |
K062077 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K062123 |
11/16/2006 |
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K062637 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K062094 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K063330 |
11/22/2006 |
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON, INC. |
HOWARD L SCHRAYER |
K062920 |
11/13/2006 |
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
K063033 |
11/01/2006 |
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT |
ORTHOPEDIC SCIENCES, INC |
JAMES BRANNON M.D. |
K062908 |
11/13/2006 |
ORTHROPRO HEMI TOE |
ORTHOPRO LLC |
J.D. WEBB |
K062051 |
11/01/2006 |
SS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
K062030 |
11/02/2006 |
US SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
K062851 |
11/17/2006 |
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED |
OSTEOMED L.P. |
PIEDAD PENA |
K051188 |
01/03/2006 |
GRAFTON DBM |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
K052716 |
11/16/2006 |
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR |
K062403 |
11/14/2006 |
IMAX CEPH DIGITAL X-RAY SENSOR |
OWANDY |
CLAUDE D BERTHOIN |
K053112 |
01/31/2006 |
BIOSIGN |
OXFORD BIOSIGNALS LIMITED |
HOWARD M HOLSTEIN |
K053283 |
01/12/2006 |
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET |
PAJUNK GMBH |
CHRISTIAN QUASS |
K063003 |
11/28/2006 |
AURORA |
PARKELL, INC. |
DANIEL R SCHECHTER |
K053516 |
01/26/2006 |
MUCOHARD |
PARKELL, INC. |
NELSON J GENDUSA |
K062300 |
11/27/2006 |
OX-SOX, MODEL C, D, E, |
PATTIENT SAFETY INNOVATIONS, LLP |
ERIK STALHANDSKE |
K062271 |
11/30/2006 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
K062455 |
11/03/2006 |
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL |
PHILIPS MEDICAL SYSTEMS |
RICH MCCLEARY |
K062605 |
11/09/2006 |
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T |
PHILIPS MEDICAL SYSTEMS |
RICH MCCLEARY |
K062233 |
11/22/2006 |
HEARTSTART MRX MONITOR/DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
MICHAEL J DOYLE |
K063315 |
11/20/2006 |
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
ANDREAS SUCHI |
K053522 |
01/10/2006 |
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HERBERT VAN DYK |
K063344 |
11/28/2006 |
CAAS QCA 3D |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
K060136 |
01/31/2006 |
PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR |
PLANAR SYSTEMS, INC. |
CRAIG HARSHMAN |
K061944 |
11/03/2006 |
POLY-CHEM CREATININE |
POLYMEDCO, INC. |
HELEN LANDICHO |
K062155 |
11/09/2006 |
DIGITAL MXR-D FLOWMETER |
PORTER INSTRUMENT CO., INC. |
CYNTHIA J.M. NOLTE |
K061951 |
11/22/2006 |
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
K063075 |
11/02/2006 |
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K053259 |
01/18/2006 |
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE |
PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD. |
GEORGE SU |
K053232 |
01/10/2006 |
PRECISION BLENDER |
PRECISION MEDICAL, INC. |
JAMES PARKER |
K053425 |
01/09/2006 |
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS |
PRECISION OPTICS CORP. |
ERWIN HEIDER |
K062166 |
11/21/2006 |
ENAMEL PRO |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K062683 |
11/21/2006 |
ENAMEL PRO VARNISH |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K063389 |
11/17/2006 |
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS SCHAPPERT |
K061517 |
11/22/2006 |
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES |
PRIME HERBS CORPORATION |
GENEVIEVE HSIA |
K050955 |
01/23/2006 |
LIFESIGN DXPRESS, MODEL LSR2000 |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
K062638 |
11/22/2006 |
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K053548 |
01/30/2006 |
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
PROTEIN POLYMER TECHNOLOGIES, INC. |
R. STEPHEN REITZLER |
K051566 |
01/17/2006 |
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER |
PROTON HEALTHCARE LTD. |
Kevin Walls |
K062955 |
11/09/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
PT. HALONI JANE |
EMMY TJOENG |
K062313 |
11/30/2006 |
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE |
PT. MAHAKARYA INTI BUANA |
VENUGOPAL NADARAJAN |
K061233 |
11/03/2006 |
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE |
PT. MAHAKARYA INTI BUANA |
V NADARAJAN |
K062817 |
11/22/2006 |
PTW DAVID IMRT QC VERIFICATION SYSTEM |
PTW-NEW YORK CORP. |
RICHARD D BARKER |
K052301 |
01/04/2006 |
FASTPACK TSH IMMUNOASSAY |
Qualigen, Inc. |
DOROTHY PETERSON |
K051113 |
01/04/2006 |
QUANTA SYSTEM ETRNA GIOVINEZZA |
QUANTA SYSTEM, S.P.A. |
GEORGE CHO |
K052442 |
01/26/2006 |
RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY |
RADIANCY (ISRAEL) LTD. |
MARGARET R FOURTE |
K063185 |
11/17/2006 |
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES |
RADIANT INNOVATION, INC. |
FRANK LIN |
K053153 |
01/13/2006 |
RANDOX CALIBRATION SERUM |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K052651 |
01/19/2006 |
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 |
RAYNER SURGICAL INC |
MARK MULLANEY |
K053168 |
01/04/2006 |
BIPAP FOCUS |
RESPIRONICS (IRELAND) LIMITED |
JOHN O'DEA |
K053174 |
01/12/2006 |
LOFLO C5 CO2 SENSOR |
RESPIRONICS NOVAMETRIX LLC |
KEVIN MADER |
K062642 |
11/02/2006 |
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A |
RF SURGICAL SYSTEMS, INC. |
KEVIN COSENS |
K062579 |
11/28/2006 |
OMNIPICC P.I. |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
K062399 |
11/17/2006 |
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
ROB CHIOINI |
K053322 |
01/06/2006 |
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS |
ROEI MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHN |
K053328 |
01/25/2006 |
BIOSPLINT SPLINTING RIBBON |
SATELEC |
STEVEN SALESKY |
K052920 |
01/12/2006 |
DELTA4 |
SCANDIDOS AB |
THOMAS MATZEN |
K053210 |
01/06/2006 |
MAYFIELD SCANMATE MOBILE CT SYSTEM |
SCHAERER MAYFIELD USA, INC. |
JEFFREY K SHAPIRO |
K053292 |
01/19/2006 |
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS |
SCIENT'X USA, INC. |
J.D. WEBB |
K062934 |
11/16/2006 |
SIERRA |
SEASPINE, INC. |
DIANA SMITH |
K063093 |
11/07/2006 |
SECTRA WORKSTATION, VERSION 11.1 |
SECTRA IMTEC AB |
CARL ALLETTO |
K063283 |
11/17/2006 |
DEFINIUM 5000 X-RAY SYSTEM |
SEDECAL S.A. |
DANIEL KAMM |
K061935 |
11/08/2006 |
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR |
SENSACARE LTD. |
STEVEN CHANG |
K053332 |
01/20/2006 |
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 |
SENTECH KOREA CORP. |
MATTHEW SON |
K051447 |
01/26/2006 |
SENTINEL PANCREATIC AMYLASE |
SENTINEL CH. SRL |
DAVIDE SPADA |
K063302 |
11/15/2006 |
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES |
SHANGHAI DENTAL INSTRUMENT FACTORY |
MARK JOB |
K052729 |
01/19/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
CHU XIAOAN |
K063373 |
11/17/2006 |
FLEX LOOP COIL SET 3T |
SIEMENS AG |
RUTH SCHNEISS |
K063507 |
11/30/2006 |
SYNGO NEURO PBV CT |
SIEMENS AG |
RALF HOFMANN |
K063138 |
11/22/2006 |
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING PH.D. |
K063085 |
11/14/2006 |
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
K062454 |
11/03/2006 |
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES |
SIEMENS MEDICAL SOLUTIONS, INC. |
JUDITH CAMPBELL |
K052423 |
01/13/2006 |
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION |
SIEMENS MEDICAL SOLUTIONS, INC. |
JUDITH CAMPBELL |
K053161 |
01/18/2006 |
SIROLASER |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K062898 |
11/13/2006 |
SBI LATERAL RHEAD IMPLANT |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
K063467 |
11/21/2006 |
SMITH & NEPHEW RF CANNULAE |
SMITH & NEPHEW, INC. |
MINNIE MILDWOFF |
K062592 |
11/29/2006 |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE |
SMITHS MEDICAL MD, INC. |
MELANIE HESS |
K062323 |
11/01/2006 |
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
K052654 |
01/30/2006 |
KLOCKNER DENTAL IMPLANT, MODEL S3M |
SOADCO, S.L. |
MARIA MITJANETA |
K062064 |
11/09/2006 |
RIVA BOND LC |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K062065 |
11/15/2006 |
RIVA LUTING PLUS |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K062341 |
11/02/2006 |
MALE REMEEX SYSTEM |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
K052519 |
11/30/2006 |
SPECTRAL WEST NILE VIRUS IGM STATUS TEST |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
K052959 |
01/27/2006 |
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS |
SSL AMERICAS |
CHRIS ROBINSON |
K052575 |
01/19/2006 |
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN |
ST. JUDE MEDICAL |
PATRICE STROMBERG |
K063010 |
11/28/2006 |
REGEN BIOCEMENT |
STEINER LABORATORIES |
GREGORY GENE STEINER |
K063267 |
11/09/2006 |
ISITE PACS, V 4. X |
STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. |
DEANA WISEMAN |
K061983 |
11/21/2006 |
STIMUPLEX PEN |
STOCKERT GMBH |
DOMINIKA SCHULER |
K052272 |
01/03/2006 |
STRAUMANN COMPUTER AIDED RESTORATION SERVICE |
STRAUMANN USA |
ELAINE ALAN |
K053362 |
01/13/2006 |
CELL-CHEX AUTO |
Streck |
KERRIE OETTER |
K053311 |
01/27/2006 |
STRYKER SCOPE WARMER |
Stryker Endoscopy |
CRYSTAL ONG |
K053528 |
01/13/2006 |
SHORT CITATION FEMORAL STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
K053514 |
01/26/2006 |
TRIATHLON TOTAL KNEE SYSTEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
K062270 |
11/22/2006 |
RADIUS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K063021 |
11/22/2006 |
PROFILER 2 |
SUN NUCLEAR CORP. |
NOEL DOWNEY |
K053209 |
01/05/2006 |
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM |
SUNTECH MEDICAL, INC. |
GEORGE MYERS |
K062884 |
11/09/2006 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
SUQIAN GREEN GLOVE CO., LTD. |
CHU XIAOAN |
K053380 |
01/18/2006 |
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K052599 |
11/07/2006 |
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A |
SUZHOU 66 VISION TECH CO., LTD. |
GONG BO |
K053208 |
01/30/2006 |
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET |
SWEMED LAB INTERNATIONAL AB |
ANDERS JOHANSSON |
K051933 |
01/03/2006 |
EXPASYL POWER APPLICATOR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K062781 |
11/21/2006 |
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY |
SYMTIUM CORPORATION |
SEAN COMER |
K062237 |
11/20/2006 |
CADI, VERSION 4 |
SYNCA MARKETING, INC. |
STEPHANE ARSENAULT |
K053022 |
01/23/2006 |
SYNTHES (USA) CHRONOS-BETA-TCP |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K063158 |
11/14/2006 |
SYNTHES ANTEGRA SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
K053135 |
01/04/2006 |
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
K052619 |
01/06/2006 |
THE FINGER GUARD |
T F & G PRODUCTS |
MARIRUTH GURLEY |
K063212 |
11/22/2006 |
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
PI-SHIOU LI |
K053028 |
01/31/2006 |
TECHDEVICE GUIDEWIRE |
TECHDEVICE CORPORATION |
LEIGH HAYWARD |
K062914 |
11/02/2006 |
HEM-O-LOK LIGATION CLIP |
TELEFLEX MEDICAL |
LORI HAYS |
K053420 |
11/15/2006 |
TENACORE SP02 SENSORS |
TENACORE HOLDINGS, INC. |
Brand Caso |
K062597 |
11/03/2006 |
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CHRISTINA L THOMAS |
K052985 |
01/19/2006 |
POWDER FREE VINYL EXAMINATION GLOVE |
TG MEDICAL (CHINA) INCORPORATION |
WU KIN YEAP |
K052984 |
01/11/2006 |
POWDERED VINYL EXAMINATION GLOVE |
TG MEDICAL (CHINA) INCORPORATION |
WU KIN YEAP |
K062183 |
11/21/2006 |
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K053228 |
01/31/2006 |
THERIGRAFT TCP PUTTY BONE VOID FILLER |
THERICS, LLC |
SUNIL SAINI |
K052822 |
01/20/2006 |
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 |
THUNDER TIGER CORP. |
KE MIN JEN |
K062812 |
11/28/2006 |
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N |
THUNDER TIGER CORP. |
JEN KE-MIN |
K061617 |
11/22/2006 |
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERTIE |
K062081 |
11/02/2006 |
LITHOGOLD |
TISSUE REGENERATION TECHNOLOGIES, INC. |
CHERITA JAMES |
K052557 |
01/17/2006 |
SUPER SHEATH INTRODUCER SHEATH |
TOGO MEDIKIT CO., LTD. |
HEIDI M ERICKSON |
K063081 |
11/09/2006 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
Mireille Lemery |
K060544 |
11/13/2006 |
SALTO TALARIS TOTAL ANKLE PROSTHESIS |
TORNIER |
MIREILLE EMERY |
K063241 |
11/09/2006 |
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K063361 |
11/21/2006 |
EXCELART VANTAGE ATLAS, MODEL MRT-1503 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K063184 |
11/03/2006 |
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K063189 |
11/03/2006 |
TSX-301A, AQUILION ONE CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K063130 |
11/02/2006 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
K060003 |
01/18/2006 |
EXCELART VANTAGE ZGV |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
K063197 |
11/30/2006 |
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K063198 |
11/30/2006 |
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K062839 |
11/09/2006 |
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K053243 |
01/20/2006 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062816 |
11/01/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
Cynthia Knapp |
K052323 |
01/19/2006 |
VERSATREK MYCO PZA KIT |
TREK DIAGNOSTIC SYSTEMS, INC. |
NADINE M SULLIVAN |
K062523 |
11/17/2006 |
TRU-MR LARYNGOSCOPE SET |
TRUPHATEK INTERNATIONAL, LTD. |
PAUL DRYDEN |
K061002 |
11/15/2006 |
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM |
U&I CORP. |
BETTY LIM |
K062688 |
11/30/2006 |
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM |
UG HEALTHCARE (USA), INC. |
KENNETH J STANTON |
K062702 |
11/29/2006 |
ULTICARE DISPOSABLE SYRINGES AND NEEDLES |
ULTIMED, INC. |
CAROLE STAMP |
K053513 |
01/13/2006 |
T-PIN |
UNION SURGICAL LLC |
AL WEISENBORN |
K061288 |
11/02/2006 |
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
FRANK GIANELLI |
K063195 |
11/29/2006 |
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 |
VALLEYLAB |
CHARLES COPPERBERG |
K062734 |
11/22/2006 |
ADJUST-RIGHT FIXATION DEVICES |
VALPO ORTHOPEDIC TECHNOLOGY, INC. |
RON CLARK |
K052004 |
01/19/2006 |
VASCON NEUROPATH GUIDING CATHETER |
VASCON LLC |
ROBERTA D GOODE |
K062822 |
11/21/2006 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 |
VASCULAR SOLUTIONS, INC. |
PATRICE STROMBERG |
K053270 |
01/27/2006 |
IVENT 201 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
K060421 |
11/03/2006 |
SONARA; SONARA/TEK |
VIASYS HEALTHCARE, INC. |
GLEN HERMANSON |
K053648 |
01/24/2006 |
PIONEER TC8080, COMPANION III |
VIASYS NEURO CARE |
Gary Syring |
K061908 |
11/06/2006 |
NICOLETONE SYSTEM V32 AMPLIFIER |
VIASYS NEUROCARE |
Gary Syring |
K062422 |
11/07/2006 |
HUMERAL HEAD, MANUAL DRIVER |
VIDACARE CORPORATION |
GRACE HOLLAND |
K062833 |
11/30/2006 |
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
K052710 |
01/13/2006 |
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, |
VIDENT |
BARBARA J LEWANDOWSKI |
K052682 |
01/06/2006 |
ALIGNRT |
VISION RT LIMITED |
NORMAN SMITH |
K062343 |
11/02/2006 |
GRANDIO FLOW TRY-IN |
VOCO GMBH |
MICHAEL SUES |
K061796 |
11/02/2006 |
HEPATOSTAT SET, MODEL 760X |
VYGON CORP. |
STEPHEN GOLDNER |
K052741 |
01/13/2006 |
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES |
W & H DENTALWERK BUERMOOS GMBH |
GABRIELE WIENBECK |
K063435 |
11/28/2006 |
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL |
W. L. GORE & ASSOCIATES, INC. |
Michael Ivey |
K062161 |
11/09/2006 |
GORE PROPATEN VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
K053169 |
01/17/2006 |
RM3 RENAL PRESERVATION SYSTEM |
WATERS INSTRUMENTS, INC. |
DAVE SCHOLLMAN |
K062917 |
11/02/2006 |
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 |
WEAR SAFE MALAYSIA SDN. BHD. |
TK LOH |
K061653 |
11/09/2006 |
SOYALA FULL FACE MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ABERS |
K053136 |
01/05/2006 |
5TH METATARSAL FRACTURE SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K053642 |
01/26/2006 |
OSTEOSET DBM PELLETS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K053588 |
01/13/2006 |
PROFEMUR LX HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K052915 |
01/27/2006 |
PROFEMUR XTR HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K062757 |
11/07/2006 |
XERON PACS |
XERON HEALTHCARE CORP. |
MELISSA MAHALL |
K053433 |
01/19/2006 |
CAUTERY TIP CLEANER, MODEL 30500 |
XODUS MEDICAL, INC. |
BRENDA NIEL |
K053321 |
01/19/2006 |
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER |
XODUS MEDICAL, INC. |
CRAIG KAFOREY |
K052176 |
01/12/2006 |
FLOWHANDY ZAN100 USB |
ZAN MESSGERATE GMBH |
JIM LEWIS |
K052997 |
01/23/2006 |
ZIMMER DENTAL ONE-PIECE IMPLANT |
ZIMMER DENTAL INC. |
ERIN MCVEY |
K053274 |
01/25/2006 |
ANATOMICAL SHOULDER INVERSE/REVERSE |
ZIMMER GMBH |
DALENE T BINKLEY |
K063303 |
11/22/2006 |
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
K053226 |
01/31/2006 |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER |
ZIMMER, INC. |
CINDY J DICKEY |
K062228 |
11/08/2006 |
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION |
ZIMMER, INC. |
PATRICIA JENKS |