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
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