FDA 510(k) Decisions During February, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K093199 12/04/2009 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK 3M COMPANY JIZHONG JIN
K083645 02/24/2009 RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS 5 STAR MEDICAL, INC. TERRY L ANCAR
K083225 02/20/2009 FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. SARAH HARRINGTON
K081495 02/04/2009 CELL-DYN EMERALD SYSTEM ABBOTT LABORATORIES MICHELLE B ROEDING
K083713 02/23/2009 .035 LOC GUIDE WIRE EXTENSION Abbott Vascular NADINE SMITH
K083706 02/06/2009 HI-TORQUE VERSACORE GUIDE WIRE Abbott Vascular NADINE SMITH
K083732 02/25/2009 TAD AND TAD II TAPERED GUIDE WIRES Abbott Vascular NADINE SMITH
K093600 12/04/2009 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM ACCELERATED CARE PLUS PATRICK PARKER
K083103 02/26/2009 ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B ACRYMED, INC. BRUCE GIBBINS
K083855 02/17/2009 MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 ACUMEN MEDICAL, INC. KEVIN MACDONALD
K083541 02/24/2009 NEONATE HEAD AND BODY COILS ADVANCED IMAGING RESEARCH, INC. RAVI SRINIVASAN
K081398 02/06/2009 ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES ADVANCED MEDICAL INNOVATIONS, INC. MARIA F GRIFFIN
K090453 02/26/2009 SILVER ALGINATE 11 WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K092371 12/23/2009 SWIFT-LOCK ANCHOR, MODEL 1192 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K083918 02/02/2009 ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K092236 12/16/2009 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. PAULA E BULGER
K083265 02/03/2009 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 AGAMATRIX INC CONNIE HERTEL
K081092 12/11/2009 MODIFICATION TO MAMMAPRINT AGENDIA Guido Brink
K083221 02/03/2009 AIDERA DIASEND AIDERA AB ANDERS SONESSON
K090269 02/13/2009 AIRSTRIP OB AIRSTRIP TECHNOLOGIES, LP WM CAMERON POWELL
K082845 02/12/2009 INFINITI VISION SYSTEM WITH OZIL IP ALCON RESEARCH, LTD. MICHAEL BUENGER
K091711 12/11/2009 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K082328 02/27/2009 GLUCODR PLUS SYSTEM, MODEL AGM-3000 ALL MEDICUS CO., LTD MARGARET KIM
K082965 12/07/2009 DS-A BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD. Ke-Min Jen
K091198 12/07/2009 LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING ALLIED HILL ENTERPRISES, LTD. PAUL A WARE
K093077 12/23/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K092936 12/04/2009 AMIGO ESCORT 7.5, MODEL 760001 PHS AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K093452 12/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 ANDON HEALTH CO.,LTD LIU YI
K093528 12/04/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 ANDON HEALTH CO.,LTD LIU YI
K092588 12/29/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 ANDON HEALTH CO.,LTD LIU YI
K092510 12/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 ANDON HEALTH CO.,LTD LIU YI
K083395 02/27/2009 SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 ANDON HEALTH CO.,LTD LIU YI
K093166 12/07/2009 WITTMANN PATCH APERTA LLC DIETMAR H WITTMANN
K090275 02/18/2009 GELPORT SINGLE INCISION ACCESS SYSTEM APPLIED MEDICAL RESOURCES CORP. FRANS VANDEBBROEK
K091884 12/09/2009 ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K093098 12/23/2009 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM ARKRAY, INC. KENNETH L BLOCK
K092943 12/11/2009 ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE ARNOLD TUBER INDUSTRIES MICHAEL TUBER
K093259 12/17/2009 ARP RX100 ARP MANUFACTURING, INC LEWIS WARD
K093050 12/18/2009 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 ARROW INTL., INC. CHRISTINE FORD
K093165 12/04/2009 ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083127 02/03/2009 ASAHI CORSAIR MICROCATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K081541 02/23/2009 DERMABLATE EFFECT ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K090940 12/14/2009 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED ASTORIA-PACIFIC,INC. CHARLES A PETERSON
K093483 12/22/2009 ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT ASTRA TECH INC. BETSY A BROWN
K090445 02/27/2009 ATMOS C361/C451 SUCTION PUMP ATMOS INC. MARCO SCHLEGEL
K082869 02/06/2009 AWBAT-S, AWBAT-D, AWBAT-M AUBREY, INC. STEPHEN MOSS
K083488 02/19/2009 JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT AUDIFON-USA INC. JANE E PERRONE
K092807 12/10/2009 HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES ECKLEIN
K083180 02/12/2009 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. AMRITA SETHI
K083313 02/02/2009 WILDCAT 7F GUIDEWIRE SUPPORT CATHETER AVINGER, INC. HIMANSHU PATEL
K092958 12/02/2009 AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES AVITA CORPORATION JENNIFER REICH
K083667 02/02/2009 NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 B-K MEDICAL APS LARS OKSBY HANSEN
K083737 02/10/2009 HALO ABLATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083711 02/02/2009 MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083778 02/20/2009 XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION DIANE RENNPFERD
K090628 12/04/2009 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 BAYER HEALTHCARE, LLC SUSAN BROCCHI
K093346 12/15/2009 BD GENEOHM MRSA ACP ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) RAYMOND BOULE
K080481 02/20/2009 ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS BECKMAN COULTER, INC. CHECHAMMA VARUGHESE
K092505 12/11/2009 BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 BECKMAN COULTER, INC. CATRIONA NEILAN
K082162 02/03/2009 COULTER BODY FLUID CONTROL BECKMAN COULTER, INC. LOURDES COBA
K093458 12/04/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K090921 12/18/2009 ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 BEIERSDORF, INC. PETER STRATTON
K092620 12/04/2009 MD300C318 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K090089 02/12/2009 BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. URAIWAN LABADINI
K090378 02/23/2009 CHROMOPHARE E 668 BERCHTOLD GMBH & CO. KG HEATH HINES
K082428 02/10/2009 N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE BEST GLOVE, INC NEIL DOW
K092214 12/15/2009 CHIROPRO L SYSTEM BIEN-AIR DENTAL, SA CYNTHIA J NOLTE
K090964 12/16/2009 BINAXNOX STAPHYLOCOCCUS AUREUS TEST BINAX, INC. SUZANNE M VOGEL
K092791 12/30/2009 KNEEHAB XP CONTROLLER, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K092793 12/07/2009 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K080008 02/23/2009 BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET BIO-RAD LABORATORIES, INC. CYNTHIA SINCLAIR
K082927 02/06/2009 BIOEMG III BIO-RESEARCH ASSOCIATES, INC. JOHN RADKE
K090296 02/19/2009 ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 BIODEX MEDICAL SYSTEMS, INC. CLYDE SCHLEIN
K080910 02/04/2009 PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS BIOIMAGENE, INC. INDU LAKSHMAN
K090181 02/11/2009 WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K091746 12/07/2009 WATERLASE MD, MODEL 7100102 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K080210 02/10/2009 PRO QR ADVANCED FORMULA POWDER BIOLIFE, LLC Karen O'Toole
K083383 02/18/2009 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K093549 12/16/2009 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM BIOMET MANUFACTURING CORP. BECKY EARL
K083827 02/13/2009 ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES BIOMET MANUFACTURING CORP. GARY BAKER
K082874 02/05/2009 BIODRIVE CANNULATED SCREW SYSTEM BIOMET TRAUMA DEBRA L BING
K090103 02/11/2009 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL BIOMET, INC. BECKY EARL
K083006 02/09/2009 BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K093455 12/04/2009 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES BIOSENSE WEBSTER, INC. Balaka Das
K091352 12/04/2009 SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 BIOSENSE WEBSTER, INC. Balaka Das
K083178 02/23/2009 SOLAS ANATOMIX SPINAL SYSTEM BIOTECHNI AMERICA SPINE GROUP, INC. DANIEL R BAKER
K081372 02/04/2009 GELX ORAL GEL BMG PHARMA LLC. WILLIAM A GOOLSBEE
K091045 12/18/2009 SMART TENS, MODEL: D-BC05T BODY CLOCK HEALTH CARE LTD RASHELLE PRESTON
K093691 12/11/2009 ACCUMAX BOSTON SCIENTIFIC CORP. NICHOLE RIEK
K081576 02/03/2009 BLAZER DX-20 DIAGNOSTIC CATHETER BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K090170 02/04/2009 SPYSCOPE ACCESS AND DELIVERY CATHETER BOSTON SCIENTIFIC CORP. ASHLEY PYLE
K093636 12/23/2009 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K093720 12/23/2009 STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO BOSTON SCIENTIFIC CORP. MARK MURPHY
K083420 02/03/2009 MEDONIC M SERIES BOULE MEDICAL AB MICHAEL ELLIOTT
K093025 12/22/2009 BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES BOVIE MEDICAL CORPORATION RICHARD KOZLOFF
K083372 12/08/2009 ARROWBONE-A, ARROWBONE-B BRAINBASE CORPORATION H. NEAL DUNNING
K093117 12/11/2009 DIGITAL LIGHTBOX BRAINLAB AG RAINER BIRKENBACH
K080987 02/06/2009 BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K083727 02/20/2009 STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 BRIDGEPOINT MEDICAL JILL MUNSINGER
K083424 02/26/2009 BUSSE SURGICAL DRAPE BUSSE HOSIPITAL DISPOSABLES MUHAMAD ANSARI
K093665 12/15/2009 ENDO SMARTCAP BYRNE MEDICAL INC. DON BYRNE
K092483 12/18/2009 BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 C.R. BARD, INC. KEVIN STEVENS
K090101 02/10/2009 EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K090102 02/12/2009 NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K093663 12/23/2009 RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. BARD, INC. JULIE BASSETT
K082693 02/23/2009 RESOLUTIONMD, RELEASE 2.1 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K092017 12/01/2009 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) CAPTIVA SPINE, INC MIKE ENSIGN
K083174 12/17/2009 HEALTHEPOD CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K082930 02/13/2009 CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE CARDIVA MEDICAL, INC. KIT CARIQUITAN
K092803 12/23/2009 CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT CARDO MEDICAL CORP. DENISE DUCHENE
K093616 12/23/2009 V. MUELLER CAMERA CONTROLLER WITH STORAGE CART CAREFUSION 2200 GINA RAJTEROWSKI
K090598 12/15/2009 CARIESCAN PRO CARIESCAN LTD. NIKOLA SKELLY
K092782 12/07/2009 INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, CARMEL PHARMA AB. KJELL ANDREASSON
K092953 12/17/2009 XPERT VANA ASSAY CEPHEID RUSSEL K ENNS
K083140 02/09/2009 COMPEX SPORT PLUS CHATTANOOGA GROUP MICHAEL TREAS
K081264 02/13/2009 STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 CHILDREN'S HEALTH FIRST, INC. ROGER T VAUGHAN
K080105 02/13/2009 ENDOTRACHEAL TUBE CHILECOM MEDICAL DEVICES CO., LTD. BRANDON CHOI
K091926 12/22/2009 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM CHOICE SPINE, LP KAREN WARDEN
K092829 12/02/2009 INSERTEASE CHRISTCOT MEDICAL COMPANY JENNIFER D ENSIGN
K093139 12/30/2009 BANTAM,48XXXXXX, 50XXXXXX CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K082556 02/06/2009 CLEARCORRECT CLEARCORRECT, INC. WILLIAM GREENROSE
K093557 12/18/2009 SMARTWAND-DTX CLEARCOUNT MEDICAL SOLUTIONS JEFF WOLFGONG
K083742 02/12/2009 SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX COLLAGEN MATRIX, INC. PEGGY HANSEN
K093051 12/07/2009 HYLATOPIC PLUS EMOLLIENT FOAM COLLEGIUM PHARMACEUTICAL INCORPORATED RONALD M GURGE
K083304 02/06/2009 TEMPOSIL 2 COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K083624 02/10/2009 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN K BENG
K081255 02/20/2009 SCRAMBLER ST 5 TENS DEVICE COMPETITIVE TECHNOLOGIES,INC. MARY MCNAMARA
K090085 02/12/2009 MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K081556 02/02/2009 CADSTREAM, VERSION 5.0 CONFIRMA, INC. BRENT LEWIS
K093513 12/16/2009 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH, RAC
K082480 02/25/2009 CONTEC POCKET FETAL DOPPLER CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K091034 12/16/2009 AQUACEL AG SURGICAL CONVATEC PATRICIA KEARINS
K082682 02/27/2009 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG COOK BIOTECH, INC. DANIEL J DILLON
K083330 02/06/2009 ECHOTIP ULTRA ULTRASOUND NEEDLE COOK ENDOSCOPY SCOTTIE FARIOLE
K090133 02/20/2009 CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS COOK, INC. KAREN BRADBURN
K093052 12/08/2009 CROSSCATH SUPPORT CATHTER COOK, INC. MOLLY BUSENBARK
K083786 02/20/2009 CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083121 02/11/2009 NEO MAPCATH SENSOR STYLET CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083287 02/03/2009 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM CORVENTIS, INC. DAWN CHANG
K080733 02/18/2009 COTTONS 100% NATURAL COTTON TAMPONS COTTONS PTY, LTD ROBERT SEIPLE
K091762 12/22/2009 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE COVIDIEN MR. WING NG
K082296 02/26/2009 COPA AMD COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR JAMES WELSH
K093372 12/03/2009 SILS PORT MODEL SILSPT15 COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR ANGELA VAN ARSDALE
K092850 12/15/2009 ENDOFLIP CROSPON, LTD. PAUL DRYDEN
K083106 02/06/2009 CRYOVALVE SG PULMONARY VALVE AND CONDUIT CRYOLIFE, INC. JOHN D FERROS
K082400 02/03/2009 DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS CULLIGAN SOFT WATER SERVICE CO. MIKE JABLONSKI
K092904 12/22/2009 PATHWAY IVB/VBR CUSTOM SPINE, INC. SAAD ATTIYAH
K083748 02/02/2009 IPULSE, MODEL: I150 CYDEN LIMITED MICHAEL KIERNAN
K092788 12/18/2009 PERIOPHIL BIPHASIC CYTOPHIL INC VICTOR M BOWERS
K090959 12/24/2009 LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) JOSEPH P D'ANTONIO
K092912 12/16/2009 STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 DANVILLE MATERIALS, INC. LINDSAY TILTON
K092032 12/08/2009 BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 DAVOL INC., SUB. C.R. BARD, INC. GAIL DOW
K093332 12/09/2009 DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) DELPHI MEDICAL SYSTEMS GILBERT ROQUE JR.
K082137 02/10/2009 DLMS-ZIRBLOCKS DENTAL MILLING LABORATORY SUPPLIES (DLMS) SCOTT ATKIN
K083252 02/18/2009 NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM DENTALEZ GROUP, STARDENTAL DIVISION DALE BRAAS
K093072 12/28/2009 STARCARE HANDPIECE MAINTENANCE UNIT DENTALEZ, INC. KAY ENGLE
K083326 02/10/2009 FLUOROCORE 2 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K092614 12/02/2009 X-SMART EASY DENTSPLY INTERNTIONAL HELEN LEWIS
K082300 02/18/2009 ANATOMIC LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K093646 12/17/2009 DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MEYER
K083107 02/09/2009 MODIFICATION TO DEPUY NEUFLEX PIP FINGER DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K073565 02/06/2009 STANDARD WHEELCHAIR PLATFORM DESIGN SPECIFIC LTD DAWN EDWARDS
K090986 12/30/2009 STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) DFINE, INC. SANDEEP SABOO
K093415 12/23/2009 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K093233 12/04/2009 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K093167 12/22/2009 STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K092170 12/22/2009 STA LIATEST FREE PS DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K093001 12/18/2009 STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INCORPORATED UMBERTO V PARROTTA
K082462 02/06/2009 GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ DIAMOND DIAGNOSTICS, INC. LIANN VOO
K093498 12/14/2009 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DIASORIN, INC. CAROL A DEPOUW
K082588 12/11/2009 GAMMALOC SYSTEM, MODEL 03-00001 DILON TECHNOLOGIES LLC ELAINE DUNCAN
K092417 12/11/2009 INSIGHT ULTRASONIC INSERTS DISCUS DENTAL, LLC WINKIE WONG
K092928 12/16/2009 DOSE VOLUME HISTOGRAM (DVH) EVALUATOR DIVERSILABS, LLC THOMAS KROENKE
K083500 02/12/2009 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC. THERON GOBER
K092488 12/18/2009 DYNAREX STERILE LUBRICATING JELLY DYNAREX CORPORATION DANIEL CONSAGA
K090526 12/02/2009 MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR E-WOO TECHNOLOGY VINCENT LEE
K082791 02/18/2009 EMS AIR-FLOW MASTER E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K093057 12/01/2009 BIOMET VISION FOOTRING SYSTEM EBI, L.P. MARGARET F CROWE
K092727 12/03/2009 H100B PULSE OXIMETER EDAN INSTRUMENTS, INC. LI FU
K091992 12/09/2009 EIDOSMED, MODEL EDG4.0 EIDOSMED, LLC DANIEL KAMM
K083629 02/19/2009 SMOOTHSHAPES ELEME MEDICAL, INC. MICHAIL PANKRATOV
K090889 12/04/2009 EMSI GARMENT ELECTRODES EMSI CHERITA JAMES
K083030 02/05/2009 TENS-EMS-14 EMSI CHERITA JAMES
K093019 12/22/2009 ENAMELITE ACRYSEAL SPRAY SEALANT ENAMELITE LLC DAVID C FURR
K092174 12/30/2009 ENABLER-P CATHETER SYSTEM, MODEL 3000 ENDOCROSS, LTD. JOHN SMITH
K081400 02/20/2009 FANNING-PAPPAS MODULAR KNEE BEARING ENDOTEC, INC. MICHAEL PAPPAS
K082825 02/06/2009 ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM ENERGIST, LTD. TIM MAJOR
K093227 12/10/2009 SILVERSTREAM AND DERMASEPT ENZYSURGE, LTD. KEREN SHTIEGMAN
K092469 12/23/2009 O-SCAN MR SYSTEM ESAOTE S.P.A. Allison Scott
K093613 12/23/2009 VASCUVIEW TAP ULTRASOUND SYSTEM ESCALON MEDICAL CORP. ROGER EDENS
K082124 02/19/2009 CARDITTE MICROTEL ET MEDICAL DEVICES SPA LUIGI BUCCHI
K091729 12/23/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K090242 02/20/2009 GAMMA-BSM, BETA-BSM ETEX CORP. CHRISTOPHER KLACZYK
K093750 12/09/2009 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA EV3 INC Laura Heaton
K082875 02/05/2009 PORTABLE X-RAY SYSTEM, MODEL DXR -1 EXARO CO., LTD. SHIN KUK YOO
K092548 12/15/2009 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS EXTREMITY MEDICAL LLC JAMY GANNOE
K093252 12/17/2009 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER FOOTPRINT MEDICAL INC. CLYDE BAKER
K083034 02/04/2009 FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F FOTONA D.D. STOJAN TROST
K093006 12/30/2009 FONIX ,MODEL 8000 FRYE ELECTRONICS, INC. KRISTINA FRYE
K090212 02/19/2009 MAC 800 RESTING ECG ANALYSIS SYSTEM GE MEDICAL SYST. INFORMATION TECHNOLOGIES LARRY LEPLEY
K093514 12/10/2009 DISCOVERY MODEL NM/CT 670 GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K093141 12/29/2009 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOE LUCAS
K083639 02/17/2009 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LARRY LEPLEY
K092639 12/02/2009 INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP GE MEDICAL SYSTEMS SCS NICOLE LANDREVILLE
K083683 02/25/2009 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC Genesee BioMedical, Inc. JOHN T.M. WRIGHT
K082027 02/13/2009 FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 GENESIS BPS LLC CAROLYN AMDITIS
K080853 02/20/2009 DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM GENEXEL-SEIN, INC. JAY MANSOUR
K081947 02/04/2009 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING GISH BIOMEDICAL, INC. HARVEY KNAUSS
K082082 02/04/2009 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING GISH BIOMEDICAL, INC. MARTIN SELLERS
K080708 02/02/2009 VISION HOLLOW FIBER OXYGENATOR WITH HA COATING GISH BIOMEDICAL, INC. HARVEY KNAUSS
K073439 02/20/2009 TRANSITION STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K083442 02/06/2009 CORRIDOR FIXATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K093242 12/23/2009 PATRIOT TRANSCONTINENTAL LLIF SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K083752 02/23/2009 GLUSEAL 90, MODEL GLU9010 GLUSTITCH, INC. DON BLACKLOCK
K092546 12/18/2009 GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM GMDASZ MANUFACTURING CO., LTD CHARLIE MACK
K083399 02/20/2009 ICS CHARTR EP 200 GN OTOMETRICS A/S DAN SANSONETTI
K082286 02/24/2009 BIOACTYS GRAFTYS ANTHONY LE NAOUR
K082498 02/25/2009 GRAFTYS HBS GRAFTYS ANTHONY LE NAOUR
K083479 02/27/2009 BIOCRYL X GREAT LAKES ORTHODONTICS, LTD. MARK LAUREN
K091851 12/28/2009 STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD FOO KHON PU
K092682 12/11/2009 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS GYRUS ACMI, INC. LORRAINE CALZETTA
K092514 12/04/2009 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K092557 12/17/2009 DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES HARVARD MEDICAL DEVICES LTD. MARTIN MA
K083457 02/13/2009 TACTIPEN HASELMEIER GMBH STEPHEN J GOLDNER, JD, RAC
K082690 02/09/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K082691 02/04/2009 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K083533 02/17/2009 ECHELON C MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEHWAITE
K083153 02/04/2009 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 HOLLISTER, INC. CHRIS STUKEL
K093644 12/18/2009 RESTORATION ADM SYSTEM X3 ACETABULAR HOWMEDICA OSTEONICS CORP. AVITAL MERL MARGULIES
K080636 02/13/2009 DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 HUBDIC CO., LTD MARIA F GRIFFIN
K083824 02/10/2009 HUMANSCAN M5S-D ULTRASOUND TRANSDUCER HUMANSCAN COMPANY, LTD. GARY ALLSEBROOK
K093639 12/03/2009 SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 HUVITZ CO., LTD. MATEW J WESS
K083468 02/10/2009 CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) i-SENS, Inc. HYUN JOON OH
K082836 02/25/2009 ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES ICU MEDICAL, INC. NILOUFAR SAMIMI
K090794 12/10/2009 OSTEOTAPE IMPLADENT, LTD. MAURICE VALEN
K090159 02/06/2009 INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES INCISIVE SURGICAL, INC. JAMES PETERSON
K090405 12/01/2009 LIPIDPRO SYSTEM INFOPIA CO., LTD PRISCILLA JUHEE CHUNG
K090177 02/20/2009 INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE INION OY KATI MARTTINEN
K083879 02/23/2009 INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) INNOVISION A/S H. CARL JENKINS
K093113 12/18/2009 ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT INSTITUT STRAUMANN AG ANDREAS PETERMANN
K081419 02/20/2009 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LISA QUAGLIA
K091701 12/22/2009 STRAUMANN MODIFIED DENTAL ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K092840 12/03/2009 INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K091111 12/02/2009 RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC INSTRUMENTATION INDUSTRIES, INC. DORIS WALTER
K091302 12/04/2009 INTEGRA MOZAIK AND OS MOLDABLE MORSELS INTEGRA LIFESCIENCES CORPORATION PETER ALLAN
K093163 12/15/2009 INTEGRA TOTAL WRIST FUSION SYSTEM INTEGRA LIFESCIENCES CORPORATION STEPHEN BEIER
K093260 12/16/2009 AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM INTERNATIONAL BIOMEDICAL, LTD. AMY PIEPER
K092883 12/18/2009 LED LAMP OR OTHER INTRAVISTA MEDICAL SYSTEMS INC WEI SU
K081137 02/18/2009 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 INTUITIVE SURGICAL, INC. KAREN UYESUGI
K090993 12/16/2009 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 INTUITIVE SURGICAL, INC. USHA S KREADEN
K093642 12/11/2009 NEUTRASAL INVADO PHARMACEUTICALS EDWARD D KOBUS
K090785 12/15/2009 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 INVIVO CORP. RUSTY KELLY
K092796 12/22/2009 IBA PROTON THERAPY SYSTEM, PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K080779 02/04/2009 IRRISEPT WOUND CLEANSING SYSTEM IRRIMAX CORPORATION JULIE STEPHENS
K083854 02/13/2009 CARDIAC TRIGGER, MODEL: CTM300 IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K092634 12/01/2009 OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO CHEN XI
K093570 12/04/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K092966 12/08/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K093534 12/16/2009 MODIFICATION TO CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K081886 02/06/2009 KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED KAREX INDUSTRIES SDN BHD LENG KIAN GOH
K073214 12/01/2009 DUOWEDGE SYNTHETIC BONE SUBSTITUTE KASIOS J.D. WEBB
K083544 02/02/2009 KAT IMPLANT SYSTEM KAT IMPLANTS, LLC VITALI BONDAR
K091585 12/29/2009 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 KCI USA, INC. MARGARET MARSH
K080949 02/11/2009 KERATEC WOUND DRESSINGS KERATEC LIMITED MARY MCNAMARA-CULLINANE
K093312 12/08/2009 KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM KIMBERLY-CLARK CORP. LESTER PADILLA
K091749 12/23/2009 U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS KIMBERLY-CLARK CORP. CHERYL SANZARE
K093375 12/02/2009 KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) KOON SENG SDN.BHD JIGAR SHAH
K083229 02/23/2009 E.S TECK ( ELECTRO SENSOR TECK) L.D. TECHNOLOGY, LLC RICHARD CLEMENT
K092344 12/17/2009 LAC-MAC INNERBLOC LR SURGICAL GOWNS LAC MAC, LTD. JEFFREY O STULL
K093285 12/10/2009 MODIFICATION TO LANX SPINAL FIXATION SYSTEM LANX, LLC ANDREW LAMBORNE
K093144 12/16/2009 LOUSEBUSTER LARADA SCIENCES PHIL TRIOLO
K082262 02/02/2009 LDR SPINE ROI INTERBODY FUSION SYSTEM LDR SPINE USA NOEL BARTSCH
K083857 02/12/2009 LDR SPINE ROI-C IMPLANT LDR SPINE USA NOAH BARTSCH
K092647 12/11/2009 LENSX 550 LASER SYSTEM LENSX LASERS, INC. Judy Gordon
K090097 02/26/2009 LH-75T PHOTOTHERAPY SYSTEM LERNER MEDICAL DEVICES, INC. ZAFIRIOS GOURGOULIATOS
K091301 12/15/2009 LIFE SPINE STAND-ALONE SPACER SYSTEM LIFE SPINE MICHAEL S BUTLER
K082772 02/09/2009 STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 LIFE-TECH, INC. JEFF KASOFF
K092550 12/15/2009 TIGRT IVS LINATECH, LLC JONATHAN YAO
K092998 12/23/2009 CONMED LINVATEC INTERCEPT IMPLANT LINVATEC CORP. DIONNE SANDERS
K083281 02/25/2009 EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- LINVATEC CORP. LISA ANDERSON
K093067 12/29/2009 LIPOSE DISPOSABLE CANNULA LIPOSE CORP. CHRISTINE EMANUEL
K083845 12/11/2009 XTAG CF60 KIT V2 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K083684 02/05/2009 ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX MANUFACTURING & RESEARCH, INC. SUZANNE DEW
K090533 12/18/2009 HLM TUBING SET WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG INGRID RICHTER
K090555 12/23/2009 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K082117 02/18/2009 QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K093522 12/07/2009 QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090518 12/18/2009 QUART ARTERIAL FILTER WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG INGRID RICHTER
K090515 12/18/2009 ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090534 12/23/2009 VENOUS HARDSHELL CARDIOTOMY RESERVIORS MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090690 12/23/2009 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K092903 12/01/2009 BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING MAQUET GMBH AND CO. KG ANNETTE JAKOB
K082019 02/06/2009 FREEDOM TOTAL KNEE SYSTEM MAXX ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K092951 12/07/2009 STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS MECTRON S.P.A. ROGER GRAY
K081463 02/06/2009 MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP MEDEL S.P.A. TERRENCE O'BRIEN
K091875 12/07/2009 E-PULSE MEDEVICE CORPORATION TZVI MILSHTEIN
K080874 02/20/2009 EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT MEDICA CORP. Photios Makris
K093714 12/10/2009 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG AM SHIM
K082988 02/13/2009 MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT MEDIVATORS REPROCESSING SYSTEMS LYNN LUEDERS
K083179 02/27/2009 MEDILED PHOTOTHERAPY LAMP MEDIX I.C.S.A. J. HARVEY KNAUSS
K083531 02/12/2009 LIQUIBAND ULTIMA, MODEL LB0004 MEDLOGIC GLOBAL LTD. TIERNEY NORSTED
K092914 12/09/2009 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES MEDSHAPE SOLUTIONS JACK GRIFFIS
K093247 12/02/2009 MEDSYNAPSE PACS SOFTWARE MEDSYNAPTIC PRIVATE, LTD. DANIEL KAMM
K083735 02/18/2009 ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS MEDTECHS, LLC MEGHAN ATH
K080635 02/13/2009 MEDTOXSCAN MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K082918 02/09/2009 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK RYAN MASSEY
K093434 12/02/2009 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA L WEISMAN
K092087 12/30/2009 MEDTRONIC DENTAL TCP MEDTRONIC SOFAMOR DANEK USA, INC. PAMELA EDWARDS
K092325 12/15/2009 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K083422 02/06/2009 6F TAIGA GUIDING CATHETER MEDTRONIC VASCULAR VIC ZHANG
K091582 12/04/2009 GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 MEDTRONIC VASCULAR COLLEEN MULLINS
K082873 02/06/2009 MEDTRONIC ANGIOGRAPHIC GUIDE WIRES MEDTRONIC VASCULAR TARA N TURNEY
K083124 02/27/2009 NIM 3.0 MEDTRONIC XOMED, INC. JAYME WILSON
K082249 12/31/2009 MORPHEUS MEIBACH TECH LTDA STUART L FRIEDEL
K083447 02/06/2009 MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 MEMOMETAL TECHNOLOGIES GILLES AUDIC
K083056 02/23/2009 NEO-STAT CO2 MERCURY MEDICAL PAUL DRYDEN
K083523 02/04/2009 MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC. SUSAN D SCOTT
K083469 02/13/2009 METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 METASURG MARK MYERS
K090046 02/27/2009 CONCERTO DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. NEELU MEDHEKAR
K092749 12/03/2009 MAS AND MINI-TROL PTH CONTROL Microgenics Corporation LISA CHARTER
K083691 02/25/2009 BONEVUE MICROMRI, INC. RICHARD ELRATH
K082565 02/12/2009 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 MICROSURGEON, INC. DUDLEY HARRIS
K093397 12/17/2009 TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE MICROVENTION, INC. Naomi Gong
K092855 12/29/2009 MILTEX MEMBRANE TACK KIT MILTEX, INC. JENNIFER BOSLEY
K092663 12/14/2009 ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K090091 02/01/2009 OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS, LLC SCOTT EDWARDS
K083371 12/08/2009 NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) NATUS MEDICAL, INC. NICOHL R WILDING
K093392 12/31/2009 MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS NAVILYST MEDICAL, INC. WANDA CARPINELLA
K090202 02/17/2009 NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 NCONTACT SURGICAL, INC. JANE RICUPERO
K083561 02/11/2009 NEOSS PROACTIVE IMPLANT NEOSS, LTD. CHERITA JAMES
K090173 02/05/2009 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K092964 12/11/2009 COOLTOUCH VARIA ND:YAG LASER SYSTEM NEW STAR LASERS, INC. NATALIE R VOLLRATH
K091118 12/16/2009 FOOT AND HAND MOTION SYSTEM NEWCLIP TECHNICS J.D. WEBB
K091457 12/08/2009 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM NEXSTIM OY CYNTHIA J NOLTE
K083205 02/13/2009 NOBELACTIVE 8.5 MM & 18.0 MM NOBEL BIOCARE AB HERBERT CRANE
K091579 12/23/2009 FORESEE HOME NOTAL VISION LTD. Judy Gordon
K083458 02/09/2009 INTRAMEDULLARY FIXATION ROD (IFS) NOVALIGN ORTHOPAEDICS, INC JEFFREY G ROBERTS
K073121 02/12/2009 NUBRACE INVISIBLE REMOVABLE ORTHODONTICS NUBRACE, INC. JONATHAN S KAHAN
K082833 02/05/2009 NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER NUTEK ORTHOPAEDICS, INC. PETER MINCIELLI
K090255 02/10/2009 BLOOD TUBING SETS (STERILE FLUID PATH) NXSTAGE MEDICAL, INC. MICHAEL DOYLE
K091838 12/04/2009 OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK OBP MEDICAL KEITH LARSON
K091364 12/11/2009 DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 OEHM UND REHBEIN GMBH ALAN SCHWARTZ
K083491 02/19/2009 NEUROSCAPE OLEA MEDICAL NEAL KOLBER
K082468 02/18/2009 APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) OMNI LIFE SCIENCE, INC. WILLIAM MCCALLUM
K090162 02/20/2009 EVICEL APPLICATION DEVICE OMRIX BIOPHARMACEUTICALS LTD. SARA HORN
K090819 12/23/2009 ONTEX TAMPON (UNSCENTED) ONTEX INTERNATIONAL NV NEAL KOBER
K092837 12/23/2009 OTI-SCAN 3000 OPKO INSTRUMENTATION, INC MARIO ARBESU
K082268 02/06/2009 CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX ORIDION CAPNOGRAPHY, INC. RACHEL WEISSBROD
K083516 02/20/2009 PERIOGENIX OROSCIENCE, INC. MARY MCNAMARA
K083680 02/27/2009 VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K091996 12/15/2009 ORTHOCOR KNEE SYSTEM BASIC ORTHOCOR MEDICAL INES BURGOS
K092044 12/18/2009 ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE ORTHOCOR MEDICAL INES BURGOS
K083067 02/02/2009 MS SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K083745 02/17/2009 THE IC-PRO SYSTEM, MODEL VERSION 3.2 PAIEON, INC. SHAHAR MANDELBOIM
K083900 02/27/2009 ERBIUM FRACTIONAL HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K083165 02/13/2009 PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K092674 12/28/2009 SIMPLER TOADSTOOL MINI IMPLANT PAN GLOBAL IMPLANT HAROLD BERGMAN
K093456 12/01/2009 JETSTREAM G3 SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K092710 12/02/2009 PENTAX ED-3490TK, VIDEO DUODENOSCOPE PENTAX MEDICAL COMPANY LISA LANCIA
K093037 12/28/2009 PENTEX EC-3890LI PENTAX MEDICAL COMPANY LISA LANCIA
K081540 02/20/2009 ZEGRA POSTURE TRAINER PETER FISCHER PETER FISCHER
K081532 02/26/2009 PHARMAJET NEEDLE-FREE INJECTION SYSTEM PHARMAJET, INC. RON BAUER
K093177 12/18/2009 INTELLIBRIDGE SYSTEM PHILIPS MEDICAL SYSTEMS CLAIRE ARAKAKI
K083740 02/13/2009 MAMMODIAGNOST VU PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K082583 02/25/2009 INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HERBERT VAN DYK
K091227 12/29/2009 PIEZOSURGERY 3; OSSTEM PIEZO PIEZOSURGERY S.R.L. ING. ENRICO PERFLER
K083663 02/25/2009 PACP PIONEER SURGICAL TECHNOLOGY JONATHAN GILBERT
K083152 02/02/2009 EQUASHIELD SYSTEM PLASTMED, LTD. ELISSA BURG
K083621 02/03/2009 MEDPOR CUSTOMIZED SURGICAL IMPLANT POREX SURGICAL, INC. JERRI L MANN
K082150 02/04/2009 MODIFICATION TO PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH WENDY BALLESTEROS
K091578 12/02/2009 LIFT CHAIR, MODEL T3 PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
K090369 02/27/2009 PRODRIVE LINE OF DENTAL HANDPIECES PRODRIVE SYSTEMS, INC. TIMOTHY F NASON
K082850 02/27/2009 EYE SPHERES PRODUCT AND EDUCATIONAL SERVICES LLC EDWARD GRIFFITH
K082771 02/27/2009 PROTRON TECHNOLOGIES, LLC STETHOTRON PROTRON TECHNOLOGIES, LLC LEON M DONDYSH
K092264 12/17/2009 ATLANTIS HYPERBARIC CHAMBER VENTILATOR PROVIDENCE GLOBAL MEDICAL, INC. HELEN REDD
K092910 12/18/2009 FLUID-FILLED TEETHER QUALIMAN INDUSTRIAL CO., LTD Kevin Walls
K080436 02/11/2009 RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 QUANTRX BIOMEDICAL CORPORATION NATALIE J KENNEL
K083600 02/19/2009 VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) QUANTUM CO., LTD. LIJUAN WANG
DEN070002 02/25/2009 QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING QUICK-MED TECHNOLOGIES, INC. ROY CARR
K092744 12/10/2009 NEONATAL ECG ELECTRODE, M203KEN R & D MEDICAL PRODUCTS, INC. JAMES PERRAULT
K082921 02/17/2009 RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 RAD SOURCE TECHNOLOGIES, INC. RANDOL E KIRK
K092534 12/07/2009 ALATUS VAGINAL BALLOON PACKING SYSTEM RADIADYNE STUART R GOLDMAN
K091507 12/04/2009 RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 RAYNER INTRAOCULAR LENSES LTD. ROYNAN H KERNAGHAN
K092125 12/10/2009 PRESIDIO PACS REAONIX SECURITY, LLC GERALD JACKSON
K091675 12/15/2009 LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER REIMERS AND JANSSEN GMBH ASTRID SCHULZE
K083051 02/20/2009 FLOWTAIN & FLOWTAIN LV RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K090135 02/17/2009 TRIMIRA IDENTAFI 3000 REMICALM, LLC DAVID B JONES
K081927 02/06/2009 RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO RENU MEDICAL, INC. L. BRUCE PIERSON
K092186 12/22/2009 VPAP TX RESMED LTD. DAVID D'CRUZ
K092648 12/18/2009 RESPIRONICS PERFORMAX SE TOTAL FACE MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K083193 02/13/2009 REVAC AUTO RETRACTABLE SAFETY SYRINGE REVOLUTIONS MEDICAL CORPORATION INC RICHARD THERIAULT
K092603 12/04/2009 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY Roche Diagnostics KATHIE J GOODWIN
K092169 12/16/2009 ELECSYS PROBNP II CALCHECK 5 Roche Diagnostics KELLY FRENCH
K083655 02/12/2009 ELECSYS TOXO IGG CALCHECK Roche Diagnostics KELLY FRENCH
K093084 12/16/2009 ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP ROLENCE ENT. INC. JEN KE-MIN
K083101 02/23/2009 PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES SABLE INDUSTRIES, INC. KEVIN RANDALL
K082995 02/06/2009 SMART DILATOR SAFESTITCH MEDICAL MARIO ARBESU
K090806 12/18/2009 SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON SAFILENS, S.R.L. JOHN M SZABOCSIK
K082407 02/03/2009 MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K091331 12/11/2009 PIEZOTOME 2 SATELEC RICK ROSATI
K083556 02/19/2009 MODIFICATION TO AUTO-BAND LIGATOR SCANDIMED INTERNATIONAL STEPHEN M PAGE
K083338 02/02/2009 CARDIFF ANTERIOR CERVICAL PLATE SYSTEM SEASPINE, INC. ETHEL BERNAL
K090238 02/27/2009 SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS SEDECAL S.A. DANIEL KAMM
K093672 12/11/2009 AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION SENTINELLE MEDICAL, INC. JOAN MEDLEY
K091541 12/31/2009 MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES SEQUAL TECHNOLOGIES CO., LTD CEARO HUANG
K092956 12/04/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG AOBO MEDICAL CO, LTD CHU XIAOAN
K082055 02/06/2009 MODEL PC-860 FETAL DOPPLER SHENZHEN CREATIVE INDUSTRY CO., LTD
K082057 02/26/2009 DX6605E-TENS, DX6605E-G, DX6609-G SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
K092820 12/03/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG FUHAO PLASTIC PRODUCTS CO., LTD. JOHN ZHAO
K092482 12/04/2009 TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 SHIPPERT MEDICAL TECHNOLOGIES CORP. SARAH L SHIPPERT
K091672 12/04/2009 DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. Diana Hong
K090686 12/08/2009 SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS SIC BREVETTI S.R.L. ROSINA ROBINSON
K093090 12/17/2009 GALILEOS IMPLANT, VERSION 1.7 SICAT GMBH & CO. KG MARKUS PFISTER
K090119 02/05/2009 SICAT IMPLANT SICAT GMBH & CO. KG MARKUS PFISTER
K083465 02/27/2009 DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS VICTOR M CARRIO
K083462 02/27/2009 DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 SIEMENS HEALTHCARE DIAGNOSTICS HELEN M LEE
K083579 02/20/2009 DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 SIEMENS HEALTHCARE DIAGNOSTICS VICTOR M CARRIO
K091361 12/16/2009 IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS CAROLYN K GEORGE
K083262 02/18/2009 MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) SIEMENS HEALTHCARE DIAGNOSTICS LIBBY WARRINER
K082638 02/26/2009 ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL Siemens Healthcare Diagnostics Inc. YUK-TING LEWIS
K083373 02/02/2009 IMMULITE 2000 FREE T4 Siemens Healthcare Diagnostics Inc. PHILIP LIU
K090276 02/19/2009 ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K082775 02/19/2009 PRESCISION OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
K093531 12/01/2009 ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS, INC. SHELLY PEARCE
K090334 02/20/2009 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS, INC. SHELLY PEARCE
K093391 12/23/2009 SIMUPLAN TREATMENT PLANNING SYSTEM SIMUPLAN S.L. LU ANNE JOHNSON
K092660 12/03/2009 SIROLASER ADVANCE SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K093428 12/17/2009 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR SMITH & NEPHEW ENDOSCOPY, INC. KATHY REDDIG
K092002 12/10/2009 AFGHAN EXTERNAL FIXATOR SMITH & NEPHEW, INC. LAURA SEJNOWSKI
K091543 12/21/2009 LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS SMITH & NEPHEW, INC. JASON SELLS
K083565 02/20/2009 PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 SMITH & NEPHEW, INC. GINO ROUSS
K083375 02/25/2009 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY SMITH & NEPHEW, INC. LAURA KREJCI
K082371 02/09/2009 SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM SMITH & NEPHEW, INC. JASON SELLS
K093228 12/15/2009 SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR SMITH & NEPHEW, INC. CHRISTINA FLORES
K093056 12/15/2009 SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM SMITH & NEPHEW, INC. JASON SELLS
K083641 02/23/2009 BIVONA TRACHEOSTOMY TUBES SMITHS MEDICAL ASD, INC. DANIEL COATES
K093601 12/18/2009 AF 840 PH.I.S.I.O. ARTERIAL FILTER SORIN GROUP ITALIA S.R.L. BARRY SALL
K091462 12/15/2009 SPECTRA MEDICAL SAFETY SCAPEL SPECTRA, INC. AGUSTIN TURRIZA
K090820 12/23/2009 TRIA HAIR REMOVAL LASER SYSTEM SPECTRAGENICS, INC. TOBIN C ISLAND
K081240 02/27/2009 TIGER DISCECTOMY DEVICE SPINAL DEVICES, LLC RICHARD JANSEN
K082992 02/18/2009 AXXION LIGHT GUIDE SPINAL ELEMENTS, INC. KERRI DIMARTINO
K083475 02/13/2009 LUCENT MAGNUM SPINAL ELEMENTS, INC. KERRI DIMARTINO
K081888 02/06/2009 DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE SPINEART FRANCK PENNESI
K093551 12/24/2009 PARADIS VASO SHIELD SPINEMEDICA, LLC SALLY THORSEN
K093583 12/15/2009 EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL TIM KAPPERS
K082683 12/08/2009 SD CHECK GOLD STANDARD DIAGNOSTICS, INC. WILLIAM GREENROSE
K092823 12/18/2009 AMSCO WARMING CABINET STERIS Corporation ROBERT F SULLIVAN
K092906 12/30/2009 VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION STERIS Corporation ROBERT F SULLIVAN
K090260 02/26/2009 MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS STRAUMANN MANUFACTURING, INC. ELAINE ALAN
K092814 12/15/2009 STRAUMANN DENTAL ABUTMENTS STRAUMANN MANUFACTURING, INC. ELAINE ALAN
K083550 02/26/2009 STRAUMANN DENTAL IMPLANT SYSTEM STRAUMANN USA ELAINE ALAN
K083926 02/11/2009 CD4 COUNT Streck KERRIE OETTER
K083200 02/03/2009 X-CAL Streck ERIN JOHNSON
K093704 12/23/2009 AVS PL PEEK SPACERS STRYKER CORP. KIMBERLY LANE
K083661 02/27/2009 AVS TL PEEK SPACERS STRYKER CORP. KIMBERLY LANE
K083009 02/19/2009 ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 Stryker Leibinger GmbH & Co. KG LILIAN ECKERT
K092605 12/03/2009 XIA 4.5 SPINAL SYSTEM STRYKER SPINE CURTIS TRUESDALE
K093393 12/24/2009 LIFEDOP MODEL 300ABI SUMMIT DOPPLER SYSTEMS, INC. KEN JARRELL
K090016 02/13/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SUQIAN CLEAN GLOVE CO., LTD. CHU XIAOAN
K083781 02/04/2009 EEA HEMORRHOID STAPLER & ACCESSORIES SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN FRANK GIANELLI
K091644 12/23/2009 SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES SYNTHES (USA) KARL J NITTINGER
K083439 02/05/2009 SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM SYNTHES (USA) AMNON TALMOR
K092929 12/29/2009 SYNTHES MATRIX SYSTEM SYNTHES (USA) SUSAN LEWANDOWSKI
K091233 12/11/2009 SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES SYNTHES (USA) ANDREA M TASKER
K083002 02/03/2009 SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K090294 02/26/2009 FORA IR22 EAR THERMOMETER, MODEL TD-1262 TaiDoc Technology Corporation Yuhua Chen
K093035 12/24/2009 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 TaiDoc Technology Corporation DEBRA LANG
K092099 12/10/2009 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 TaiDoc Technology Corporation DEBRA LIANG
K093439 12/22/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN PUFA PLASTIC PRODUCTS CO., LTD. JOHN ZHAO
K083259 02/17/2009 PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE TANGSHAN ZHONGYING PLASTIC PRODUCTS CO., LTD. JOHN ZHAO
K083898 02/04/2009 SURGIMEND TEI BIOSCIENCES INC. KENNETH JAMES
K090435 12/21/2009 VERTECEM TEKNIMED SA J.D. WEBB
K082623 02/25/2009 VISIX IMAGING TELEVERE SYSTEMS BARBARA DEAY
K082377 02/09/2009 TENSCARE ITOUCH MODEL(S) EASY AND PLUS TENSCARE LTD ANTHONY JANKEL
K092644 12/10/2009 TERUMO PRESSURE ISOLATOR TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K082321 02/13/2009 TERUMO ROCSAFE HYBRID PERFUSION SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP. GARY A COURTNEY
K090040 02/06/2009 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) TERUMO MEDICAL CORP. MARK UNTERREINER
K092450 12/28/2009 HUMAN IGD KIT FOR USE ON SPAPLUS THE BINDING SITE JAY GELLER
K090920 12/30/2009 HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) THE BINDING SITE, LTD. JAY H GELLER
K082129 02/10/2009 HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER THE BINDING SITE, LTD. JAY H GELLER
K083269 02/03/2009 CROSSOVER THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K083710 02/23/2009 RETRACTOR LITE THOMAS SURGICAL INSTRUMENTS, INC. STEPHANIE A ZALUCHA
K091051 12/08/2009 BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM TITA-LINK JOSEPH AZARY
K093546 12/17/2009 SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX TOGO MEDIKIT CO., LTD. FUMIAKI KANAI, PH.D
K093313 12/02/2009 SYNERGY TOPCON MEDICAL SYSTEMS, INC. MAUREEN O'CONNELL
K083268 02/12/2009 TORNIER, INC., INSITE SUTURE ANCHORS TORNIER, INC. HOWARD L SCHRAYER
K090158 02/06/2009 APLIO ARTIDA V2.0 SSH-880CV TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K083503 02/13/2009 DRAD30003/RADREX-I TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K093171 12/04/2009 VIAMO SSA-640A VERSION 1.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K090220 02/11/2009 COLON VIEW, MODEL CSCV-001A TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K083828 02/11/2009 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT TRANSOMA LISA STONE
K092445 12/16/2009 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, LTD. CYNTHIA C KNAPP
K073071 02/06/2009 EQ-PRC LC WARFARIN GENOTYPING KIT TRIMGEN CORPORATION HOWARD DOONG
K090636 12/02/2009 TSO3 OZONE STERILIZER, MODEL 125L TSO3 INC. CHARLES O HANCOCK
K090122 02/05/2009 NUOVOGUARD U.S. SAFETY SYRINGES CO., INC. CHRISTINA SMITH
K092771 12/02/2009 DYNA LOCKING IM NAIL U&I CORP. GYEONG-JE KWON
K082201 02/20/2009 G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A US DIAGNOSTICS, INC. JONATHAN J JOHNSON
K093250 12/24/2009 PROTON THERAPY MULTILEAF COLLIMATOR VARIAN MEDICAL SYSTEMS VY TRAN
K093527 12/15/2009 ARIA RADIATION ONCOLOGY WITH MIRS VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K081560 02/10/2009 VASCUTEK CANNULA GRAFT, MODEL CGS2008S VASCUTEK LTD. KAREN KELSO
K093525 12/10/2009 ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE VENTLAB CORP. JAMES A COCHIE
K091934 12/02/2009 IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 VERAN MEDICAL TECHNOLOGIES, INC. SCOTT WRIGHTSTONE
K093675 12/23/2009 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K091426 12/23/2009 CERVICORE CORPECTOMY CAGE VERTICOR, LTD J.D. WEBB
K093446 12/03/2009 VITA VMK MASTER VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. ELIZABETH WOLFSEN
K082727 02/06/2009 FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN VITROLIFE SWEDEN AB KJELL KJORK
K090832 12/23/2009 RAPID-I VITROLIFE SWEDEN AB KJELL KJORK
K083438 02/13/2009 BIFIX SE VOCO GMBH TH. PLAUMANN
K090362 02/27/2009 IMAG, IPOD, EZ-FIND AND ISLIDE VOGUESTRAP MARIA F GRIFFIN
K092596 12/10/2009 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER VOLCANO CORPORATION LORRY HUFFMAN
K090931 12/15/2009 CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR W & H DENTALWERK BUERMOOS GMBH JOHANN GEORG SCHARL
K083300 02/04/2009 GORE FLOW REVERSAL SYSTEM W.L. GORE & ASSOCIATES,INC MICHELLE A WELLS
K082404 02/25/2009 NAVIGATION PROBES WE SENSE LTD NABIL JADAON
K081479 02/20/2009 ADVANCE A-CLASS TIBIAL INSERT WRIGHT MEDICAL TECHNOLOGY, INC. FRED W BOWMAN
K093591 12/03/2009 STIMPOD MODEL NMS-400 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. BRIAN ROTHMAN
K083734 02/11/2009 AXXENT SURFACE APPLICATOR, MODEL 710257 XOFT, INC. STEVE LIN
K083309 02/13/2009 ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 ZARGIS MEDICAL CORP. JOHN KALLASSY
K090027 02/02/2009 BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 ZEN STRONG MEDICAL TECHNOLOGY CO., LTD CHENG ROIE-SHENG
K083324 02/25/2009 LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM ZEST ANCHORS, INC. RICHARD A OVERTON
K083047 02/12/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO WANCI PLASTIC & RUBBER CO., LTD JOHN ZHAO
K092438 12/23/2009 ZIEHM SOLO ZIEHM IMAGING, INC. RICHARD L WESTRICH
K093164 12/15/2009 3.25 SPLINE TWIST IMPLANT, HA COATED ZIMMER DENTAL INC. LARISSA D'ANDREA MCMULLIN
K083497 02/19/2009 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS ZIMMER, INC. CAROL VIERLING
K083654 02/26/2009 ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) ZIMMER, INC. ANTHONY FRANCALANCIA
K091265 12/23/2009 ZOLL E SERIES WITH CPRREADYCHARGE ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE
K092598 12/03/2009 ZOLL E SERIES WITH SPCO/SPMET OPTION ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact