| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K073296 |
01/09/2008 |
TEMPXN28 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K073395 |
01/17/2008 |
GILB-2, GLASS IONOMER PROTECTIVE COATING |
3M ESPE DENTAL PRODUCTS |
KAREN O'MALLEY |
| K072653 |
01/24/2008 |
3VISEON/SURGERY |
3MENSIO MEDICAL IMAGING BV |
CARL THOMAS |
| K072174 |
01/25/2008 |
INSUCOZI INSULIN VIAL COVER |
41 INDUSTRIES LLC |
DANIEL LAFAVER |
| K082734 |
11/13/2008 |
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K082714 |
11/19/2008 |
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K082762 |
11/12/2008 |
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE |
AARDVARK MEDICAL |
|
| K071788 |
01/11/2008 |
AVIATOR INSULIN PUMP |
ABBOTT DIABETES CARE INC. |
SARAH HARRINGTON |
| K081975 |
11/26/2008 |
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K073202 |
01/30/2008 |
ARDIS SPACER |
ABBOTT SPINE, INC. |
MARITZA ELIAS |
| K072798 |
01/31/2008 |
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
DANIELLE M TAYLOR |
| K073530 |
01/31/2008 |
ACCIN ANTERIOR CERVICAL PLATE SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K073068 |
01/10/2008 |
ACCIN HIP SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K072252 |
01/30/2008 |
VEINOPLUS NEUROMUSCULAR STIMULATOR |
ADREM TECHNOLOGY SARL |
NORMAN F ESTRIN |
| K073233 |
01/28/2008 |
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS |
ADVANCED BIO-SURFACES, INC. |
PHILIP B JARVI |
| K080503 |
11/12/2008 |
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K082392 |
11/13/2008 |
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH ASCENZI, PH.D. |
| K073719 |
01/29/2008 |
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
| K082991 |
11/20/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K073573 |
01/30/2008 |
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM |
AGAMATRIX |
CONNIE HERTEL |
| K080013 |
01/17/2008 |
REGISTRATION AND FUSION |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
| K081062 |
11/07/2008 |
AIRSONNETT AIRSHOWER AIR 3 |
AIRSONETT, INC. |
CONSTANCE G BUNDY |
| K073171 |
01/31/2008 |
RESUSCITATION TIMER, MODEL L770-CPR |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K070514 |
01/30/2008 |
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO |
ALN IMPLANTS CHIRURGICAUX |
DAVE PARENTE |
| K072887 |
01/25/2008 |
G-TRAINER MEDICAL |
ALTER-G, INC. |
GLEN MANGSETH |
| K082284 |
11/20/2008 |
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM |
ALVEOLUS, INC |
TONY ALEXANDER |
| K082861 |
11/25/2008 |
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEXANDER B HENDERSON SR. |
| K072596 |
01/24/2008 |
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEXANDER B HENDERSON |
| K073505 |
01/09/2008 |
MODIFICATION TO VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
| K073430 |
01/29/2008 |
VALEO PEDICLE SCREW SPINAL SYSTEM |
AMEDICA CORP. |
JUSTIN EGGLETON |
| K082730 |
11/26/2008 |
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K073703 |
01/30/2008 |
AMS MINIARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
BRAD ONSTAD |
| K082266 |
11/07/2008 |
DIGITAL CLINICAL THERMOMETER MODEL V9XX |
AMPEROR-ELECTRONIC(SZ) CO., LTD |
LARRY YANG |
| K073464 |
01/23/2008 |
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K073672 |
01/24/2008 |
SKATER BILIARY CATHETER |
ANGIOTECH |
TRUDY ESTRIDGE |
| K082457 |
11/10/2008 |
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) |
ANSELL HEALTHCARE PRODUCTS, INC. |
CYNTHIA A INGRAM |
| K082575 |
11/25/2008 |
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES |
APATECH LTD. |
CANDACE F CEDERMAN |
| K081979 |
11/06/2008 |
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K080467 |
11/25/2008 |
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, |
APPLIED DNA TECHNOLOGIES, INC. |
FENG YU-LEE |
| K073452 |
01/11/2008 |
MODIFICATION TO: ARAGON SURGICAL LAPCAP |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K073632 |
01/10/2008 |
INTUITION, MODEL 0170 |
ARCOMA AB |
BENGT-HUGO JOHANSSON |
| K081011 |
11/07/2008 |
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 |
AREX USA |
ELLEN HOKANSON |
| K073451 |
01/15/2008 |
PRESSURE INJECTABLE PICC |
ARROW INTERNATIONAL, INC. |
KEVIN LENTZ |
| K071456 |
01/17/2008 |
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT |
ARTHREX, INC. |
MARIELA CABARCAS |
| K082980 |
11/05/2008 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K070945 |
01/09/2008 |
ASAHI PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K083146 |
11/21/2008 |
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K080294 |
11/04/2008 |
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT |
ASTORIA-PACIFIC,INC. |
JASON REYNOLDS |
| K073014 |
01/23/2008 |
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN |
AUTOGENOMICS, INCORPORATED |
EVELYN G LOPEZ |
| K083189 |
11/21/2008 |
STERI-LUB LUBRICATION GEL |
AVAIL MEDICAL PRODUCTS, INC. |
PATRICIA A GOEREE |
| K081940 |
11/18/2008 |
AVALON ELITE VASCULAR ACCESS KIT |
AVALON LABORATORIES, LLC |
LEE WIRTH |
| K072754 |
01/25/2008 |
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE |
AXENIC DENTAL, INC. |
JOSEPH T SOBOTA |
| K072760 |
01/29/2008 |
SOLCART B |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
TRACY MADDOCK |
| K072875 |
01/22/2008 |
NIO 5MP DISPLAY, MODEL E5620 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K082538 |
11/20/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K073433 |
01/14/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K072825 |
01/14/2008 |
FINGERTIP PULSE OXIMETER, MODEL MD300I |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K082125 |
11/21/2008 |
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT |
BEST GLOVE, INC |
NEIL DOW |
| K083148 |
11/07/2008 |
TELECTRODE WET GEL ECG ELECTRODE |
BIO PROTECH, INC. |
KEVIN HAN |
| K082011 |
11/28/2008 |
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K073080 |
01/24/2008 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
Bio-Rad Laboratories |
MARIA ZEBALLOS |
| K082381 |
11/14/2008 |
GENEX |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K073663 |
01/30/2008 |
GELSPRAY WOUND DRESSING |
BIOCURE, INC. |
JOHN GREENBAUM |
| K072647 |
01/25/2008 |
GLYCERIN & PARABEN FREE ASTROGLIDE |
BIOFILM, INC. |
ROBERT DE ARMOND |
| K081818 |
11/13/2008 |
BIOLOK MICRO-LOK IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K083069 |
11/13/2008 |
EZLASE 10W |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K071734 |
01/25/2008 |
WATERLASE MD DERM |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K072779 |
01/24/2008 |
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K073406 |
01/23/2008 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K072363 |
01/31/2008 |
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX |
BIOMET 3I, INC. |
DIANA TAYLOR |
| K072879 |
01/14/2008 |
INNERVUE DIAGNOSTIC SCOPE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
SUSAN ALEXANDER |
| K082432 |
11/21/2008 |
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
BIOPTICS, INC. |
PATRICIA WADE |
| K082933 |
11/03/2008 |
PASSEO-35 PTA CATHETER |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K073318 |
01/16/2008 |
BIPORE BALLOON DILATION CATHETER |
BIPORE, INC. |
KEITH PALUCH |
| K072124 |
01/18/2008 |
BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES |
BLACK & BLACK SURGICAL, INC. |
NORMAN M BLACK, III |
| K073654 |
01/24/2008 |
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K082253 |
11/25/2008 |
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J. MEEUWSEN |
| K082971 |
11/13/2008 |
BONART ART-L5 LED CORDLESS CURING LIGHT |
BONART CO. LTD. |
ERIC L ONG |
| K072862 |
01/22/2008 |
BOSTON-BAND CRANIAL REMODLING ORTHOSIS |
BOSTON BRACE INTL., INC. |
JAMES H WYNNE |
| K082568 |
11/17/2008 |
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K073018 |
01/23/2008 |
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
BRAINLAB AG |
RAINER BIRKENBACH |
| K082508 |
11/21/2008 |
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K073082 |
01/09/2008 |
CPS COURIER GUIDEWIRE |
BRIVANT, LTD. |
TOMAS FUREY |
| K073090 |
01/15/2008 |
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K073472 |
01/09/2008 |
VACCESS PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
JENNIFER LOGVIN |
| K083139 |
11/25/2008 |
VIPERSPHERE PTA BALLOON CATHETER |
CARDIOVASCULAR SYSTEMS, INC. |
David Brooke |
| K073038 |
01/11/2008 |
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K073539 |
01/31/2008 |
PROVISA CEM |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K072652 |
01/18/2008 |
ENTERAL FEEDING SPIKE ADAPTER |
CEDIC S.R.L. |
GIANCARLO GAGLIARDONI |
| K081088 |
11/06/2008 |
MYRAY SKYVIEW |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K072662 |
01/16/2008 |
CHEETAH RELIANT, CHEETAH ACTIVE |
CHEETAH MEDICAL INC. |
BENNY ARAZY |
| K071631 |
01/18/2008 |
NICOM ELECTRODES |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K072777 |
01/24/2008 |
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
MARTINA HEIM |
| K082628 |
11/20/2008 |
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 |
CIRCLE CARDIOVASCULAR IMAGING INC. |
SHIRANTHA SAMARAPPULI |
| K081858 |
11/05/2008 |
RETCAM 3 OPHTHALMIC IMAGING SYSTEM |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
| K073336 |
01/04/2008 |
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 |
Codman & Shurtleff, Inc. |
EMILY E VALERIO |
| K072790 |
01/11/2008 |
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 |
CONFLUENT SURGICAL,INC |
VIRGINIA VETTER |
| K073481 |
01/07/2008 |
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES |
CONMED LINVATEC |
JOY LOVETT |
| K082641 |
11/10/2008 |
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K073496 |
01/23/2008 |
OPTILITE HOLMIUM LASER FIBERS |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K082066 |
11/07/2008 |
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K063223 |
01/23/2008 |
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS |
COOPERSURGICAL, INC. |
JOSEPH AZARY |
| K071736 |
01/04/2008 |
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
JACK P DOUGLAS |
| K082322 |
11/14/2008 |
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS |
COVIDIEN |
VIRGINIA VETTER |
| K082454 |
11/07/2008 |
MICROMYST APPLICATOR, MODEL 20-5000 |
COVIDIEN |
VIRGINIA VETTER |
| K072687 |
11/25/2008 |
VALLEYLAB MICROWAVE ABLATION GENERATOR |
COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON |
PHILIP E AKE |
| K082619 |
11/07/2008 |
SILS PORT, MODELS SILSPT5, SILSPT12 |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K062970 |
01/22/2008 |
I-PAD |
CU MEDICAL SYSTEMS, INC. |
ELAINE DUNCAN |
| K083321 |
11/26/2008 |
CARDIO-VIEW |
CURLVIEW IGT, LLC |
|
| K071883 |
01/23/2008 |
IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 |
CYDEN LIMITED |
MICHAEL KIERNAN |
| K080121 |
01/31/2008 |
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K072381 |
01/30/2008 |
SOFTPAP CERVICAL CELL COLLECTOR |
CYTOCORE, INC. |
RICHARD DOMANIK |
| K072219 |
01/18/2008 |
CYTOPHIL TISSUE MARKER |
CYTOPHIL INC |
Greg Johnson |
| K082606 |
11/10/2008 |
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) |
D3 RADIATION PLANNING |
NABIL ADNANI |
| K073587 |
01/18/2008 |
DERMAPAL WITH DIGITAL TIMER |
DAAVLIN DISTRIBUTING CO. |
TARA MANSUR |
| K073055 |
01/03/2008 |
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K073701 |
01/28/2008 |
DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 |
DANE TECHNOLOGIES |
OLIVER PITTENGER |
| K073707 |
01/30/2008 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K073242 |
01/03/2008 |
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 |
DELPHI MEDICAL SYSTEMS |
GILBERT ROQUE |
| K081287 |
11/21/2008 |
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT |
DEN-MAT HOLDINGS, LLC |
ALAN MATTHEWS |
| K073101 |
01/17/2008 |
AURAVENEER CEMENT |
DENALI CORPORATION |
JAN G STANNARD |
| K073218 |
01/07/2008 |
MTA ADVANCED MATERIAL |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K082974 |
11/07/2008 |
MYSTIQUE MB CERAMIC BRACKETS |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K073173 |
01/23/2008 |
SELF-ADHESIVE RESIN CEMENT |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K072989 |
01/28/2008 |
AXIS SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K072762 |
01/22/2008 |
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM |
DEPALT INC. |
RAJEEV PATEL |
| K082282 |
11/07/2008 |
HEALIX TI ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON CO. |
KRISTINE CHRISTO |
| K073412 |
01/17/2008 |
GRYPHON BR AND HEALIX BR ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K073413 |
01/30/2008 |
DEPUY ASR 300 ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR |
| K073676 |
01/29/2008 |
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K072963 |
01/09/2008 |
DEPUY PINNACLE ALTRX ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K082500 |
11/18/2008 |
DEPUY SIGMA CR-F FEMORAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K073529 |
01/24/2008 |
DEPUY SIGMA PS FEMORAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K082128 |
11/14/2008 |
DEPUY SPINE LATERAL CAGE SYSTEM |
DEPUY SPINE |
DENISE DUCHENE |
| K073649 |
01/25/2008 |
BENGAL STACKABLE CAGE SYSTEM |
DEPUY SPINE, INC. |
SHARON SLAROWICZ |
| K072385 |
01/11/2008 |
HEARTEVENT, MODEL AT |
DIAGNOSTIC DEVICES PTY LTD |
HARRY PLATT |
| K073390 |
11/21/2008 |
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS |
DIASORIN, INC. |
Mari Meyer |
| K082050 |
11/03/2008 |
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081685 |
11/18/2008 |
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081687 |
11/10/2008 |
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K072395 |
01/03/2008 |
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS |
DIAZYME LABORATORIES |
CHARLES YU |
| K082763 |
11/12/2008 |
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B |
DIAZYME LABORATORIES |
Abhijit Datta |
| K072469 |
01/03/2008 |
DIGIFLO CONCENTRATOR ANALYZER |
DIGIFLO, INC. |
MIKE STERN |
| K072292 |
01/07/2008 |
NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS |
DIMA ITALIA SRL |
LEWIS WARD |
| K082512 |
11/07/2008 |
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER |
DIMENSIONAL DOSING SYSTEMS, INC. |
EJ Smith |
| K073503 |
01/23/2008 |
VERSA LITE |
DIOMEDICS, INC. |
GARY MOCNIK |
| K072002 |
01/31/2008 |
FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 |
DRAEGER MEDICAL AG & CO. KG |
KATHY ANDERSON |
| K082600 |
11/26/2008 |
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) |
DRAEGER MEDICAL B.V. |
JOYCE KILROY |
| K082888 |
11/26/2008 |
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 |
Draeger Medical Systems, Inc. |
PRADEEP GUPTA |
| K073113 |
01/03/2008 |
INFINITY PICCO POD, MODEL MS16734 |
Draeger Medical Systems, Inc. |
GENCI OMARI |
| K062534 |
01/29/2008 |
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE |
DRG INTL., INC. |
Gary Lehnus |
| K080064 |
01/23/2008 |
FLAATZ 750 |
DRTECH CORP. |
BEOM-JIN MOON |
| K082261 |
11/06/2008 |
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
DXRAD SOLUTIONS LTD. |
DANIEL KAMM |
| K080036 |
01/16/2008 |
PORTABLE ECSCOPE 12I |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K082187 |
11/13/2008 |
BIOMET ANTERIOR LUMBAR PLATE |
EBI, L.P. |
VIVIAN KELLY MS, RAC |
| K082369 |
11/07/2008 |
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K082602 |
11/26/2008 |
FETAL & MATERNAL MONITOR, MODEL F6, F9 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K073559 |
01/31/2008 |
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
JOHN W NICHOLSON |
| K080075 |
01/28/2008 |
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
CHARISE DE BARROS |
| K073687 |
01/09/2008 |
HABIB LAPAROSCOPIC HEXABLATE |
EMCISION, LTD. |
NAGY HABIB |
| K072634 |
11/19/2008 |
EMG TRITON -COMP,MODEL NCA01-XXX SERIES |
EMG TECHNOLOGY CO., LTD. |
SALLY CHUANG |
| K082844 |
11/25/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K072888 |
01/10/2008 |
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) |
ENCORE MEDICAL, L.P. |
TIFFANY HUTTO |
| K073267 |
01/30/2008 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K082339 |
11/20/2008 |
ENABLER-P SUPPORT CATHETER |
ENDOCROSS, LTD. |
JOHN J SMITH |
| K082655 |
11/25/2008 |
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K080049 |
01/23/2008 |
VASCUVIEW ULTRASOUND SYSTEM |
ESCALON MEDICAL CORP. |
MARK WALLACE |
| K082579 |
11/20/2008 |
EVERCROSS .035 OTW PTA DILATATION CATHETER |
EV3 INC. |
David Worrell |
| K072590 |
01/04/2008 |
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM |
EVENT MEDICAL, INC. |
ROBERT LUNDBERG |
| K080278 |
11/28/2008 |
TABATABA COTESTER |
FIM MEDICAL |
DANIEL KAMM |
| K071104 |
01/14/2008 |
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
FLIER'S QUALITY WATER SYSTEMS INC |
JAMES FLIER |
| K073289 |
01/11/2008 |
MICROSHEATH XL CATHETERS |
FLOWCARDIA, INC. |
Dustin Michaels |
| K072114 |
01/28/2008 |
IMPULSE 6000D/7000DP |
FLUKE BIOMEDICAL |
COLLEEN BOSWELL |
| K072870 |
01/14/2008 |
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) |
FOUNDRY NEWCO X, INC. |
GREGORY MATHISON |
| K080649 |
11/25/2008 |
POGO SCREW |
FXDEVICES |
RICH LIPSCHUTZ |
| K082740 |
11/26/2008 |
GC AADVA ZR DISK |
GC AMERICA, INC. |
MARK HEISS |
| K082434 |
11/14/2008 |
GDLS-200 |
GC AMERICA, INC. |
MARK HEISS |
| K082540 |
11/28/2008 |
GE ENTROPY SENSOR |
GE HEALTHCARE |
JOEL C KENT |
| K083018 |
11/14/2008 |
CENTRICITY PACS WEB DIAGNOSTIC |
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS |
JILLIAN M REED |
| K073625 |
01/25/2008 |
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM |
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES |
MARGARET MUCHA |
| K080124 |
01/31/2008 |
VENTRI 1.1 |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K073462 |
01/11/2008 |
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOEL KENT |
| K082851 |
11/19/2008 |
MULTLINK CABLE AND LEADWIRE SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MATTHIAS BUERGER |
| K072664 |
11/21/2008 |
GE LUNAR FEMUR STRENGTH SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES RASKOB |
| K073167 |
01/04/2008 |
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER |
GE MEDICAL SYSTEMS, LLC |
|
| K083147 |
11/04/2008 |
DISCOVERY MR450 |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K072523 |
01/22/2008 |
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS |
GENERAL ATOMICS |
CHARLES YU |
| K082243 |
11/07/2008 |
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS |
GENERAL MEDICAL MERATE S.P.A. |
Kevin Walls |
| K082205 |
11/20/2008 |
FACTOR VIII ANTIBODY SCREEN |
GENETIC TESTING INSTITUTE |
MICHELLE A STAPLETON |
| K073517 |
01/03/2008 |
H-LINK INTEGRATED ROD |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K082252 |
11/05/2008 |
INDEPENDENCE SPACER |
GLOBUS MEDICAL, INC. |
KELLY BAKER |
| K072970 |
01/18/2008 |
PATRIOT SPACERS |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K072991 |
01/18/2008 |
PATRIOT SPACERS: COLONIAL ACDF |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K081906 |
11/14/2008 |
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K071778 |
01/30/2008 |
HERO VASCULAR ACCESS DEVICE |
GRAFTCATH INC. |
LAURIE LYNCH |
| K081889 |
11/12/2008 |
RHAPSODY CT |
GRANTADLER CORPORATION |
ARTHUR WARD |
| K082126 |
11/13/2008 |
RHAPSODY MRI |
GRANTADLER CORPORATION |
ARTHUR WARD |
| K072432 |
01/09/2008 |
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE |
HAND BIOMECHANICS LAB, INC. |
JEFF WOODHOUSE |
| K072566 |
01/09/2008 |
HANGER CRANIAL BAND |
HANGER PROSTHETICS & ORTHOTICS, INC. |
IVAN J WASSERMAN |
| K080019 |
01/29/2008 |
HARDYDISK AST DORIPENEM 10 UG |
HARDY DIAGNOSTICS |
WENDY PHILLIPS |
| K073292 |
01/18/2008 |
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K073310 |
01/18/2008 |
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL |
HITACHI MEDICAL CORP. |
DOUG THISTLEWAITE |
| K072906 |
01/23/2008 |
SILK'N |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K073190 |
01/11/2008 |
SLIT LAMP |
HUVITZ CO., LTD. |
CHARLIE MACK |
| K073656 |
01/25/2008 |
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM |
HYPERMED, INC. |
CHAS BURR |
| K071646 |
01/31/2008 |
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 |
IDEV TECHNOLOGIES, INC. |
TIMOTHY R PLACEK |
| K081806 |
11/07/2008 |
IDI IMPLANT SYSTEM |
IDI BIOMEDICAL LLC |
ANGELA BLACKWELL |
| K073114 |
01/17/2008 |
IMIX INSIGHT X-RAY SYSTEMS |
IMIX ADR FINLAND OY |
DANIEL KAMM |
| K071240 |
01/24/2008 |
IMPLASA-HOECHST GMBH IMPLANTS |
IMPLASA-HOECHST GMBH |
BENNY ARAZY |
| K082706 |
11/06/2008 |
INFINITT CARDIOLOGY PACS |
INFINITT CO., LTD. |
CARL ALLETTO |
| K082990 |
11/20/2008 |
INFINITT XELIS |
INFINITT CO., LTD. |
TRISTAN CHOI |
| K072925 |
01/10/2008 |
CANDELA-INOLASE SERENITY PRO PSF SYSTEM |
INOLASE, LTD. |
GEORGE J HATTUB |
| K072967 |
01/28/2008 |
QUANTA LITE F-ACTIN IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K081773 |
11/06/2008 |
OSV II |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JON CAPAROTTA |
| K083115 |
11/26/2008 |
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 |
INTEL CORP. |
TAE-WOONG KOO |
| K073105 |
01/03/2008 |
PEEK SPINAL SPHERES |
INTERBODY INNOVATIONS, LLP |
J.D. WEBB |
| K072688 |
01/11/2008 |
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 |
INTERNATIONAL BIOPHYSICS CORP. |
DAVID SHOCKLEY |
| K073689 |
11/13/2008 |
LEP2000 THERAPY SYSTEM |
INTERNATIONAL MEDICAL INSTRUMENTS, INC. |
M. JOYCE HEINRICH |
| K082987 |
11/06/2008 |
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL |
INVIVO |
ANDREW ADAMS |
| K081673 |
11/14/2008 |
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE |
IONICS MEDICAL CORP. |
M. LAINE MASHBUM |
| K072607 |
01/25/2008 |
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K072608 |
01/30/2008 |
LYOPHILIZED MULTIBLAST MEDIUM KIT |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K081943 |
11/24/2008 |
MODEL ES-130 |
ITO CO., LTD. |
KENNETH L BLOCK |
| K082349 |
11/21/2008 |
JARIT HULKA UTERINE TENACULUM FORCEPS |
J. JAMNER SURGICAL INSTRUMENTS, INC. |
JENNIFER BOSLEY |
| K080623 |
11/17/2008 |
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA |
JAS Diagnostics, Inc. |
SAMUEL BURGOS |
| K072833 |
01/24/2008 |
P-NAIN SYSTEM |
JEISYS MEDICAL, INC. |
Kevin Walls |
| K080024 |
01/24/2008 |
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 |
K2M, INC. |
RICHARD W WOODS |
| K072914 |
01/03/2008 |
NATURAL BRIDGE LP TRANSVERSE CONNECTORS |
K2M, INC. |
RICHARD W WOODS |
| K081380 |
11/19/2008 |
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K073257 |
01/25/2008 |
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K073209 |
01/29/2008 |
MAXCEM 2 |
KERR CORPORATION |
COLLEEN BOSWELL |
| K082347 |
11/18/2008 |
DIGITAL RADIOGRAPHY, FLEXDR C30 |
KONICA MINOLTA TECHNOPRODUCT CO., LTD. |
RUSSEL MUNVES |
| K073655 |
01/28/2008 |
PEGASUS STEERABLE (PTCA) GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K081981 |
11/17/2008 |
LANG DENTAL ACRYLIC PRIMER |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K073144 |
01/24/2008 |
LANX INTERVERTEBRAL BODY FUSION DEVICE |
LANX, LLC |
GREG CAUSEY |
| K081570 |
11/07/2008 |
DPL THERAPY SYSTEM |
LED TECHNOLOGIES, LLC |
LEWIS WARD |
| K083340 |
11/26/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K073479 |
01/09/2008 |
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073480 |
01/04/2008 |
LIFE SPINE CROSS CONNECTOR |
LIFE SPINE |
REBECCA M BROOKS |
| K082056 |
11/07/2008 |
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 |
LIFE-TECH, INC. |
JEFF KASOFF |
| K082176 |
11/14/2008 |
LTM-BPS SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K082348 |
11/18/2008 |
FIBERNET EMBOLIC PROTECTION SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| DEN070013 |
01/03/2008 |
ID-TAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K073461 |
01/25/2008 |
ORTHO ANCHOR SCREWS |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K082153 |
11/25/2008 |
MAJOR.REPAIR |
MAJOR PRODOTTI DENTARI S.P.A. |
MONICA FUNAI |
| K072806 |
01/24/2008 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K081867 |
11/25/2008 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K082172 |
11/28/2008 |
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM |
MAKO SURGICAL CORPORATION |
WILLIAM F TAPIA |
| K082412 |
11/10/2008 |
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 |
MAPQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K071774 |
01/23/2008 |
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K070605 |
01/04/2008 |
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K072190 |
01/16/2008 |
ORTHO-WRAP BIORESORBABLE SHEET |
MAST BIOSURGERY |
KENNETH K KLEINHENZ |
| K082541 |
11/26/2008 |
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM |
MEDI NUCLEAR CORP., INC. |
JERRY SCHOEN |
| K080823 |
11/17/2008 |
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT |
MEDICA CORP. |
Photios Makris |
| K081505 |
11/19/2008 |
THERAGEM PROFESSIONAL T1002 |
MEDICA HEALTH, LTD |
TERRI CMOREY |
| K082475 |
11/07/2008 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
DEBBIE KIDDER |
| K073139 |
01/30/2008 |
SMALL LUMEN PERITONEAL CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K083076 |
11/20/2008 |
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K082463 |
11/10/2008 |
PROGENIX |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K072265 |
01/09/2008 |
PROGENIX DMB PUTTY |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K082002 |
11/24/2008 |
PROGENIX PLUS |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K081080 |
11/21/2008 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
| K083071 |
11/14/2008 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
| K082581 |
11/14/2008 |
C-QUEST |
MEDX, INC. |
WILLIAM GREENROSE |
| K073513 |
01/14/2008 |
MERITS E700 PORCE LIFT |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K072978 |
01/17/2008 |
TENDER ORTHO BOND-ENA BOND-ENA ETCH |
MICERIUM S.P.A. |
EUGENIO MICELI |
| K073198 |
01/11/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K082881 |
11/24/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K071782 |
01/10/2008 |
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES |
MICROMED S.P.A. |
MONICA CAMILLO |
| K073131 |
01/18/2008 |
MICROMRI WRIST COIL |
MICROMRI, INC. |
Hrishikesh Gadagkar |
| K071939 |
01/11/2008 |
HYDROCOIL EMBOLIC SYSTEMS (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K080613 |
11/06/2008 |
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 |
MINIMALLY INVASIVE DEVICES LLC |
MICHAEL H SOUTHWORTH |
| K082627 |
11/07/2008 |
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL |
MINXRAY, INC. |
DANIEL KAMM |
| K080217 |
11/05/2008 |
COMPONENT NEUROMONITORING SYSTEM |
MOBERG RESEARCH, INC. |
Damon Lees |
| K072684 |
01/04/2008 |
MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM |
MONDEAL NORTH AMERICA, INC |
JAY EVANS |
| K072257 |
01/30/2008 |
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K073665 |
01/25/2008 |
ALGO 5 NEWBORN HEARING SCREENER |
NATUS MEDICAL, INC. |
TOM BOLES |
| K082354 |
11/18/2008 |
STEREO NAVIGATOR ACCESSORY, STN-1000 |
NAVISCAN PET SYSTEMS |
HEATHER JALISI |
| K072881 |
01/09/2008 |
NEOMED Enteral FEEDING TUBE |
NEOMED, INC. |
PENNY NORTHCUTT |
| K072751 |
01/02/2008 |
COOLTOUCH MODELS NS 160 AND LC215 COOLIPO |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K080976 |
11/10/2008 |
NEXUS I.V. FLUID TRANSFER DEVICE |
NEXUS MEDICAL, LLC |
LARRY SMITH |
| K081123 |
11/14/2008 |
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS |
NEXUS MEDICAL, LLC |
LARRY SMITH |
| K073491 |
01/11/2008 |
EEG-1100A SWITCH BOX |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K082785 |
11/26/2008 |
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K072635 |
01/17/2008 |
CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 |
NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. |
Diana Hong |
| K081128 |
11/07/2008 |
MOLAR IMPLANT |
NOBEL BIOCARE AB |
THUONG NGUYEN SON |
| K073142 |
01/11/2008 |
NOBELREPLACE HEXAGONAL IMPLANT |
NOBEL BIOCARE USA LLC |
KAM LEUNG |
| K083100 |
11/19/2008 |
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP |
NOBEL BIOCARE USA, LLC |
HERBERT CRANE |
| K082441 |
11/21/2008 |
NORDICICE SOFTWARE |
NORDICIMAGINGLAB AS |
STIAN SCISLY SAGEVIK |
| K073088 |
01/10/2008 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K073130 |
01/10/2008 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K082113 |
11/07/2008 |
NOX T3, NOXTURNAL (PC APPLICATION) |
NOX MEDICAL |
KOLBRUN E OTTOSDOTTIR |
| K082642 |
11/07/2008 |
ONCENTRA RT VIEWER 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K083028 |
11/13/2008 |
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K073275 |
01/29/2008 |
NUVASIVE HELIX MINI ACP SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K072420 |
01/22/2008 |
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE |
OCEANIC MEDICAL PRODUCTS, INC. |
HOWARD HOLSTEIN, ESQ |
| K072917 |
01/14/2008 |
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM |
ODONTIT SA |
MARIO GERSBERG |
| K081456 |
11/06/2008 |
OLYMPUS CHF TYPE V |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K082720 |
11/05/2008 |
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K073313 |
01/02/2008 |
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K080460 |
11/14/2008 |
SPECTRAL OCT/SLO |
OPKO HEALTH, INC. |
JANE HSIAO |
| K073670 |
01/25/2008 |
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 |
OREX COMPUTED RADIOGRAPHY LTD |
DAN LAOR |
| K082838 |
11/25/2008 |
ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN CAMBRIA |
| K082949 |
11/25/2008 |
ORTHOPEDIATRICS BONE SCREWS |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083033 |
11/06/2008 |
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
DEBORAH L JACKSON |
| K081986 |
11/14/2008 |
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE |
Oscor Inc. |
MILA DOSKOCIL |
| K072770 |
01/22/2008 |
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) |
Oscor Inc. |
MILA DOSKOCIL |
| K072871 |
01/10/2008 |
MS SYSTEM (PROVISIONAL) |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
| K082108 |
11/14/2008 |
OBC BONE ANCHORED HEARING AID SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG |
| K073512 |
01/14/2008 |
START JUNIOR |
OTTO BOCK HEALTH CARE, LP |
BERT HERMAN |
| K082907 |
11/18/2008 |
IC-PRO SYSTEM, VERSION 3.1.0.4 |
PAIEON, INC. |
SHAHAR MANDELBOIM |
| K080241 |
11/28/2008 |
DDS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K072969 |
01/24/2008 |
DSS |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K083125 |
11/21/2008 |
NEURON SELECT CATHETER SIZE 070 |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K082803 |
11/13/2008 |
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
| K072149 |
01/15/2008 |
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 |
PHADIA US INC. |
MARTIN MANN |
| K080591 |
11/14/2008 |
TANDA SKINCARE SYSTEM, MODEL: PTSCS |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K083228 |
11/24/2008 |
PHILIPS INTELLIVUE MP5 PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
JENS-PETER SEHER |
| K072703 |
01/10/2008 |
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080026 |
01/28/2008 |
QUANTUM-MIS CANNULATED SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K073662 |
01/17/2008 |
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS |
PLAYTEX PRODUCTS, INC. |
KEITH EDGETT |
| K072869 |
01/14/2008 |
POINTCARE NOW SYSTEM |
POINTCARE TECHNOLOGIES INC. |
MAURICE N DOIRE |
| K083048 |
11/21/2008 |
NEORAY DR 2520 DIGITAL IMAGING SYSTEM |
PORTAVISION MEDICAL LLC |
TERRY ANCAR |
| K073441 |
01/24/2008 |
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K081460 |
11/21/2008 |
TDS ABUTMENT |
POU YU BIOTECHNOLOGY CO., LTD. |
LINDA K SCHULZ |
| K082415 |
11/25/2008 |
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V |
PREMCO MEDICAL SYSTEMS, INC. |
HAROLD JACOBS |
| K073039 |
01/24/2008 |
SPERMCHECK VASECTOMY |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K082688 |
11/07/2008 |
PRO HMPV+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K073029 |
01/04/2008 |
PROFLU+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K073630 |
01/11/2008 |
MODIFICATION TO: BPCARD, MODEL Z-7000-0700 |
QRS DIAGNOSTIC, LLC. |
MARY KAY JENSEN |
| K082240 |
11/20/2008 |
SNTRYPACS |
QSTAR TECHNOLOGIES, INC. |
HERMAN OOSTERWIJK |
| K083160 |
11/07/2008 |
1.5T ATLAS SPEEDER HEAD-NECK COIL |
QUALITY ELECTRODYNAMICS |
|
| K083078 |
11/26/2008 |
QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 |
QUANTA COMPUTER INC. |
JENNIFER REICH |
| K083207 |
11/14/2008 |
ULTRAWAVE III EX 1320 |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K083181 |
11/26/2008 |
QV-9000 UNIVERSAL SYSTEM |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
| K072331 |
01/07/2008 |
RADIANCY MISTRAL DEVICE |
RADIANCY (ISRAEL) LTD. |
ZVI LADIN |
| K083255 |
11/21/2008 |
16CH AI BREAST COILS 1.5 T AND 3 T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
| K072953 |
01/07/2008 |
REDLINE ALCOHOL BREATH TESTER |
REDLINE PRODUCTS (PTY) LTD. |
HUGH A BUTLER |
| K072238 |
01/25/2008 |
BIOSET XCH |
REGENERATION TECHNOLOGIES, INC. |
TRAVIS AROLA |
| K081025 |
11/21/2008 |
ISOELASTICU |
REMI SCIENCES, INC. |
SANJIV H NAIDU |
| K072615 |
01/04/2008 |
TXCONTROL |
RESMED LTD. |
DAVID D'CRUZ |
| K082654 |
11/25/2008 |
ENTERAL ONLY EXTENSION SET |
RESPIRONICS, INC. |
ANDREW P ZELTWANGER |
| K081420 |
11/07/2008 |
VANISHPOINT I.V. CATHETER |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K082553 |
11/21/2008 |
REXASTOM ORAL EASE |
REXADERM, INC. |
CLYDE R GOODHEART |
| K072753 |
01/25/2008 |
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES |
RG MEDICAL USA |
WINFRIED REICH |
| K072736 |
01/22/2008 |
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES MEWBORNE |
| K070511 |
01/14/2008 |
RICHTER MALE LATEX CONDOM |
RICHTER RUBBER TECHNOLOGY SBN BHD |
SUBRAMANIAM NARAYANASAMY |
| K072920 |
01/31/2008 |
HANDHELD BASE UNIT |
ROCHE DIAGNOSTICS CORP. |
JASON FISHER |
| K082101 |
11/05/2008 |
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K073206 |
01/16/2008 |
NEEDLE-TRAP/NEEDLE SAFETY LABEL |
SCHREINER MEDIPHARM |
Lee Leichter |
| K073169 |
01/09/2008 |
SCIMAGE PICOMENTERPRISE |
SCIMAGE, INC. |
GARY J ALLSEBROOK |
| K082310 |
11/10/2008 |
HOLLYWOOD, PACIFICA, REDONDO, VENTURA |
SEASPINE, INC. |
JEFF BRITTAN |
| K080442 |
11/13/2008 |
SERISCAFFOLD SURGICAL MESH |
SERICA TECHNOLOGIES, INC. |
CONNIE H GARRISON |
| K082876 |
11/10/2008 |
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY |
SHARPLIGHT TECHNOLOGIES LTD. |
ILAN SHARON |
| K073152 |
01/10/2008 |
PC-180 / PRINCE 180 EASY ECG MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
|
| K072581 |
01/08/2008 |
PM-60 PULSE OXIMETER |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K071287 |
01/09/2008 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K071291 |
01/09/2008 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K071289 |
01/09/2008 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K072067 |
01/08/2008 |
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 |
SHUENN BAO SHING CORPORATION |
Ke-Min Jen |
| K080398 |
11/26/2008 |
SI JOINT FUSION SYSTEM |
SI-BONE, INC. |
JEFFERY DUNN |
| K083035 |
11/13/2008 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
SUZANNE SCHWALLER |
| K080004 |
01/23/2008 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
TAMMY B CARREA |
| K082430 |
11/14/2008 |
SYNGO IMAGING XS |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K073238 |
01/03/2008 |
SYNGO VOLUME PERFUSION-CT NEURO |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K070665 |
01/04/2008 |
LITHOSKOP |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIM RENDON |
| K082506 |
11/21/2008 |
SYMBIA, VERSION 4.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GUNHILD PAULSEN |
| K082427 |
11/07/2008 |
SYNGO MR B17 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELIZABETH LAZARO |
| K082142 |
11/13/2008 |
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
SHELLY PEARCE |
| K083141 |
11/07/2008 |
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SIMPACT LLC |
MARK SCHENK |
| K082215 |
11/03/2008 |
OSTEORAPTOR SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
JULIE ACKER |
| K082211 |
11/14/2008 |
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS |
Smith & Nephew, Inc |
LAURA KREJCI |
| K072417 |
01/10/2008 |
SMITH & NEPHEW MIS HIP STEM |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K082358 |
11/25/2008 |
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K082200 |
11/25/2008 |
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 |
SOADCO, S.L. |
MARIA MITJANETA |
| K081145 |
11/05/2008 |
MODIFICATION TO 4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K073004 |
01/30/2008 |
SOMNOMED BFLEX |
SOMNOMED INC. |
ASHLEY TRUITT |
| K081313 |
11/19/2008 |
SH14 HEMOCONCENTRATOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K073050 |
01/25/2008 |
SAFESTEP MAX POWER-INJECTABLE INFUSION SET |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
Mark Nelson |
| K082674 |
11/28/2008 |
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE |
SPECTRA MEDICAL DEVICES, INC. |
SCOTT HENDERSON |
| K073351 |
01/24/2008 |
CRYSTAL |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K071420 |
01/16/2008 |
CHAMELEON FIXATION SYSTEM |
SPINEFRONTIER, INC. |
THOMAS CARLSON |
| K073093 |
01/22/2008 |
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K073092 |
01/29/2008 |
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K081026 |
11/05/2008 |
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 |
SPORT-ELEC S.A. |
SHARON SCANNELL |
| K080796 |
11/17/2008 |
SRI LP DRAPE |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080707 |
11/13/2008 |
SRI PLR GOWN |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080723 |
11/13/2008 |
SRI LP GOWN |
SRI/SURGICAL EXPRESS, INC. |
JEFFERY O STULL |
| K083083 |
11/06/2008 |
AGILIS NXT STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
| K073563 |
01/31/2008 |
MODIFICATION TO PROXIS SYSTEM |
ST. JUDE MEDICAL |
LINH PHAM |
| K082773 |
11/19/2008 |
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K073683 |
01/25/2008 |
VERIFY CHALLENGE PACKS - VERSION 2 |
STERIS Corporation |
JOHN SCOVILLE |
| K072691 |
01/31/2008 |
CERVICAL MD, MODEL C10 |
STI MEDICAL SYSTEMS |
ROLF WOLTERS |
| K080430 |
11/21/2008 |
STOMA BONE BLOCK SCREW |
STORZ AM MARK GMBH |
FRANZ MENEAN |
| K073628 |
01/22/2008 |
SYNOCTA ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K072575 |
01/07/2008 |
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K081805 |
11/14/2008 |
CUFFALERT |
SUNMED |
PAUL DRYDEN |
| K072834 |
01/09/2008 |
SIBEL SA VASCULAR CLAMP |
SURGICAL INSTRUMENTS BELGIUM SA |
WILLIAM F GREENROSE |
| K072415 |
01/25/2008 |
STALIF (TM) C |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K072913 |
01/04/2008 |
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM |
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY |
PAULA A GRAY |
| K083039 |
11/26/2008 |
VERITAS COLLAGEN MATRIX (DRY) |
SYNOVIS SURGICAL INNOVATIONS |
JODI JORGENSON |
| K082276 |
11/18/2008 |
SYNTHEMED DEVICE |
SYNTHEMED, INC. |
ELI PINES |
| K082807 |
11/24/2008 |
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS |
SYNTHES (USA) |
JILL R SHERMAN |
| K082072 |
11/07/2008 |
SYNTHES (USA) 3.5MM LCP HOOK PLATE |
SYNTHES (USA) |
KARL J NITTINGER |
| K082624 |
11/10/2008 |
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K073135 |
01/29/2008 |
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS |
SYNTHES (USA) |
JILL SHERMAN |
| K082650 |
11/18/2008 |
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
SYNTHES (USA) |
JILL R SHERMAN |
| K082335 |
11/10/2008 |
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K082572 |
11/24/2008 |
USS ILIOSACRAL, USS POLYAXIAL |
SYNTHES SPINE |
JASON LIPMAN |
| K072434 |
01/10/2008 |
SYNTHES OC FUSION AND SYNAPSE SYSTEMS |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K073667 |
11/19/2008 |
NITI-S BILIARY STENT |
TAEWOONG MEDICAL CO., LTD |
CATHRYN N CAMBRIA |
| K073094 |
01/04/2008 |
VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
TELEMEDIC SYSTEMS LTD |
GERALD L BUSS |
| K082013 |
11/10/2008 |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
TELOVITAL GMBH TELEMEDIZIN |
Calley Herzog |
| K081335 |
11/14/2008 |
TENACORE OXYGEN BLENDER, MODEL TB-2000 |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K072166 |
01/24/2008 |
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER |
THE BINDING SITE |
JAY GELLER |
| K072849 |
01/18/2008 |
MODIFICATION TO THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K072745 |
01/04/2008 |
Y-GLIDE |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K073431 |
01/14/2008 |
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T |
Tianjin New Bay Bioresearch Co., Ltd. |
ARMANDO TORRESCANO |
| K073495 |
01/09/2008 |
TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT |
TISSUELINK MEDICAL, INC. |
Som Kovvuri |
| K073087 |
11/18/2008 |
NON-CONTACT TONOMETER, MODEL FT-1000 |
TOMEY CORPORATION |
KOJI KUBO |
| K080771 |
11/10/2008 |
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC |
TOP CORP. |
CATHRYN N CAMBRIA |
| K080038 |
01/22/2008 |
VANTAGE TITAN, MODEL MRT-1504/S3 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073514 |
01/11/2008 |
TRANS1 AXIAL FIXATON SYSTEM |
TRANS1 INCORPORATED |
WILLIAM JACKSON |
| K080650 |
11/26/2008 |
OMNI-DL SYSTEM |
TRANSVIVO INC. |
J. MICHAEL DELMAGE |
| K073424 |
01/22/2008 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K063091 |
01/16/2008 |
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 |
TYRX PHARMA, INC. |
MASON W DIAMOND |
| K080532 |
11/12/2008 |
BENACEL, MODELS C-001, C-002 AND C-005 |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K072538 |
01/30/2008 |
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER |
UNITED MEDICAL SYSTEMS, INC. |
JEFFREY K SHAPIRO |
| K082646 |
11/03/2008 |
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER |
USCI IRELAND |
MAUREEN O'CONNELL |
| K083190 |
11/12/2008 |
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
| K072332 |
01/10/2008 |
VARI-LASE WIRE FIBER |
VASCULAR SOLUTIONS, INC. |
DEBORAH NEYMARK |
| K081725 |
11/07/2008 |
ENTERAL PUMP SET, MODEL 20-1010 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K073069 |
01/25/2008 |
MODIFICATION TO AVEA VENTILATOR |
VIASYS RESPIRATORY CARE INC |
TOM GUTIERREZ |
| K083227 |
11/18/2008 |
VIDA PULMONARY WORKSTATION 2 (PW2) |
VIDA DIAGNOSTICS, INC. |
JACK SLOVICK |
| K081713 |
11/21/2008 |
VERTEBRAL ACCESS SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K080446 |
11/26/2008 |
RAPIDVIT AND RAPIDWARM CLEAVE |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K082604 |
11/21/2008 |
VIZTEK DR, MODELS: DR1000, DR3000, DR4000 |
VIZTEK, INC. |
DANIEL KAMM |
| K082753 |
11/24/2008 |
FUTURABOND M/FUTURABOND M SINGLE DOSE |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K073473 |
01/14/2008 |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 |
VOLCANO CORPORATION |
ARLENE BLADES |
| K071554 |
01/04/2008 |
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
LORRY W HUFFMAN |
| K082299 |
11/20/2008 |
VERICORE IMPLANT ABUTMENTS |
WHIP-MIX CORP. |
DAVID J STEINBOCK |
| K073535 |
01/07/2008 |
BIOFOAM BONE WEDGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRAD SHEALS |
| K082320 |
11/05/2008 |
DARCO SMALL SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K072367 |
01/09/2008 |
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K082963 |
11/24/2008 |
WU'S 4-WHEELED NEO SCOOTER, WT-M3A |
WU'S TECH CO., LTD. |
JEN KEN-MIN |
| K072943 |
01/28/2008 |
BUTREX BUTTRESS PLATING SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K073306 |
01/07/2008 |
XORANCONNECT |
XORAN TECHNOLOGIES, INC. |
AMY S KIM |
| K071608 |
01/11/2008 |
A&J POCA01 OXYGEN CONCENTRATOR |
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
POLO CHEN |
| K072121 |
01/07/2008 |
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER |
ZIMMER, INC. |
PATRICIA JENKS |
| K082078 |
11/03/2008 |
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
