FDA 510(k) Applications Received During January, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K093650 11/25/2009 BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM MEDTRONIC INC. JEFFREY KOLL
K093604 11/20/2009 ETEST MOXIFLOXACIN 0.002-32 UG/ML AB BIOMERIEUX ASA KARLSSON
K093318 11/03/2009 ACCELERATOR APS ABBOTT LABORATORIES MARK LITTLEFIELD
K092705 11/17/2009 ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 ABBOTT MOLECULAR, INC. PAULA E MARTIN
K090060 01/09/2009 NEXLINK OCT SYSTEM, MODEL 7000 SERIES ABBOTT SPINE, INC. DAVID PADGETT
K083738 01/08/2009 HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 ABBOTT VASCULAR NADINE SMITH
K093600 11/20/2009 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM ACCELERATED CARE PLUS PATRICK PARKER
K093594 11/19/2009 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. COURTNEY KALOF
K093518 11/13/2009 ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K093657 11/25/2009 ADAGIO RETRACTING ECG LEAD WIRES ACIST MEDICAL SYSTEMS, INC. AL SAALABI
K090057 01/08/2009 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES CO. RICHARD LENART
K090031 01/05/2009 ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 ACTHERM, INC. RICHARD HSIEH
K083539 01/15/2009 INFANT CARDIAC ARRAY ADVANCED IMAGING RESEARCH, INC. RAVI SRINIVASAN
K083541 01/15/2009 NEONATE HEAD AND BODY COILS ADVANCED IMAGING RESEARCH, INC. RAVI SRINIVASAN
K093649 11/25/2009 AESCULAP STERILCONTAINER S AESCULAP KATHY RACOSKY
K093493 11/10/2009 AESCULAP STERILCONTAINER S AESCULAP, INC. KATHY RACOSKY
K090138 01/21/2009 MOBILECARE MONITOR, MODEL 2100 AFRAME DIGITAL, INC. DARREN REEVES
K093476 11/09/2009 AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 AGA MEDICAL CORP. AMANDA JOHNSON
K090169 01/23/2009 SPECTRA FLUORESCENCE CARIES DETECTION DEVICE AIR TECHNIQUES, INC. NATALYA VALERIO
K090061 01/09/2009 AIRSTRIP OB AIRSTRIP TECHNOLOGIES, LP
K090024 01/05/2009 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, LLC MICHAEL RENNER
K093488 11/10/2009 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K090228 01/30/2009 ROC LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K093495 11/10/2009 OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS AMERICAN DIAGNOSTIC CORP. MICHAEL FALCO
K093588 11/19/2009 EXPLORER 4D TREATMENT PLANNING SYSTEM AMERICAN RADIOSURGERY, INC. DAN OLIVIER
K093571 11/24/2009 ZR DENTAL BLOCK AMS CO., LTD CLAUDE YANG
K093452 11/09/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 ANDON HEALTH CO.,LTD LIU YI
K093528 11/16/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 ANDON HEALTH CO.,LTD LIU YI
K093406 11/02/2009 MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 ANGIODYNAMICS, INC. JODI LYNN FRASIER
K093567 11/18/2009 ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM ANOVA IMPLANT SOLUTIONS, LLC WALTER SPIRES
K093523 11/13/2009 MICRO-TOUCH NITRILE ANSELL HEALTHCARE PRODUCTS LLC CYNTHIA A INGRAM
K090043 01/13/2009 AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 APEX BIOTECHNOLOGY CORP. THOMAS Y.S. SHEN
K093579 11/18/2009 PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC GERARD J PRUD'HOMME
K090107 01/15/2009 MINI TIGHTROPE ARTHREX, INC. SALLY FOUST
K093483 11/09/2009 ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT ASTRA TECH INC. BETSY A BROWN
K083871 01/06/2009 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE ASTRA TECH, INC. BETSY A BROWN
K090130 01/21/2009 ATMOS S041 WOUND ATMOS INC. CARL ALLETTO
K093679 11/27/2009 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 ATRICURE, INC. JAMES LUCKY
K093431 11/04/2009 CLEARWAY OTW MODEL 85912 ATRIUM MEDICAL CORP. RAYMOND KELLY
K090121 01/21/2009 PRE-FILLED CATHETER INFLATION SYRINGE AVAIL MEDICAL PRODUCTS, INC. PATRICIA A GOEREE
K083723 01/15/2009 A6 LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. BONNIE J KINCAID, RAC
K083689 01/07/2009 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. LINDA MORGAN
K090141 01/21/2009 PRONTOSAN ANTIMICROBIAL WOUND GEL B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K083737 01/13/2009 HALO ABLATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083711 01/12/2009 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
K090002 01/02/2009 ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A BAXTER HEALTHCARE CORP. DONNA DJINOVICH
K090096 01/15/2009 ALL-IN-ONE CONTAINER BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K093458 11/06/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K090089 01/14/2009 BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. URAIWAN LABADINI
K093678 11/27/2009 PLATELIA ASPERGILLUS EIA MODEL 62793 BIO-RAD CHRISTOPHER BENTSEN
K093577 11/18/2009 LIQUICHEK OPIATE CONTROL BIO-RAD LABORATORIES ELIZABETH PLATT
K093630 11/27/2009 BIODENTA DENTAL IMPLANT SYSTEM BIODENTA SWISS AG DAVID EILER
K090003 01/02/2009 ZETAJET BIOJECT, INC. KRIS RICHARD
K090181 01/26/2009 WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K093549 11/17/2009 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM BIOMET MANUFACTURING CORP. BECKY EARL
K083779 01/05/2009 MAK OSS KNEE FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K083782 01/05/2009 REGENEREX PATELLA COMPONENTS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K093629 11/23/2009 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K090103 01/15/2009 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL BIOMET, INC. BECKY EARL
K090208 01/28/2009 BIOPRO FEMORAL HEADS BIOPRO, INC. DAVID MRAK
K090017 01/02/2009 CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES BIOSENSE WEBSTER, INC. BALAKA DAS
K093455 11/05/2009 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES BIOSENSE WEBSTER, INC. BALAKA DAS
K093566 11/18/2009 CARTO XP EP NAVIGATION SYSTEM, VERSION 10 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K090120 01/23/2009 REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 BIOSENSE WEBSTER, INC. BALAKA DAS
K090050 01/07/2009 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K093470 11/06/2009 CORE-FLO D/C BISCO, INC. MICHELLE SCHILTZ-TAING
K090175 01/23/2009 UNITY BETA PLLA SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K093691 11/30/2009 ACCUMAX BOSTON SCIENTIFIC CORP. NICHOLE RIEK
K090170 01/23/2009 SPYSCOPE ACCESS AND DELIVERY CATHETER BOSTON SCIENTIFIC CORP. ASHLEY PYLE
K093636 11/24/2009 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K090113 01/21/2009 BREAS VIVO 40 SYSTEM BREAS MEDICAL AB BIRGITTA BOLANDER
K093515 11/13/2009 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON BRIVANT, LTD. TOMAS FUREY
K093423 11/03/2009 LUNGPOINT PROCEDURE PLANNING BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K090095 01/15/2009 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM BRONCUS TECHNOLOGIES, INC. MAHTAB FATEMI
K093665 11/25/2009 ENDO SMARTCAP BYRNE MEDICAL INC. DON BYRNE
K093659 11/25/2009 ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 C.R. BARD, INC. JONI CREAL
K090101 01/15/2009 EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K090134 01/21/2009 INTRAVENOUS POWER INJECTOR EXTENSION SET C.R. BARD, INC. SCOTT PEASE
K090102 01/15/2009 NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K093663 11/25/2009 RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. BARD, INC. JULIE BASSETT
K090211 01/28/2009 INFLATABLE BONE TAMP CARDINAL HEALTH, INC. SHARON NICHOLS
K093463 11/06/2009 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION SHARON NICHOLS
K093616 11/19/2009 V. MUELLER CAMERA CONTROLLER WITH STORAGE CART CAREFUSION 2200 GINA RAJTEROWSKI
K090014 01/02/2009 CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE CAREMATE MEDICAL DEVICE CO., LTD XIAOMING HONG
K093521 11/13/2009 GDXPRO CARL ZEISS MEDITEC INC JUDY A BRIMACOMBE
K090068 01/09/2009 STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K093696 11/30/2009 SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 CENTRAL MEDICARE SDN BHD NICK WANG
K090229 01/30/2009 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. BOB LEIKER
K090013 01/02/2009 CHEMPAQ XBC ANALYZER CHEMPAQ A/S LONE HOFFENSETS
K083913 01/06/2009 CHESSON LABS LIQUID BANDAGE CHESSON LABORATORY ASSOCIATES, INC. SCOTT E NEUVILLE
K090100 01/29/2009 SOFTSEAL-STF CHITOGEN, INC. JANNA BEREUTER
K083771 01/07/2009 RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP CLARITY MEDICAL SYSTEMS GARY A SEEGER
K093565 11/18/2009 PLEURAFLOW CATHETER SYSTEM CLEAR CATHETER SYSTEMS MONICA DOUGHERTY
K093557 11/16/2009 SMARTWAND-DTX CLEARCOUNT MEDICAL SOLUTIONS JEFF WOLFGONG
K083554 01/15/2009 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 CLINIQA CORPORATION DAWN GAST
K083567 01/14/2009 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW CO-LIGNE AG DAVID W SCHLERF
K090216 01/29/2009 COLLAGEN DENTAL MEMBRANE IV COLLAGEN MATRIX, INC. PEGGY HANSEN
K090217 01/29/2009 BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 COLOPLAST A/S SURESH GHAL
K083351 01/26/2009 PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P COMDEK INDUSTRIAL CORP. Y.S. KUO
K090085 01/13/2009 MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K093610 11/20/2009 MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K090193 01/27/2009 CONDUCTOR CORONARY GUIDEWIRE CONCERT MEDICAL, LLC PAMELA PAPINEAU
K093513 11/17/2009 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH, RAC
K093556 11/17/2009 VCARE DX CONMED CORPORATION SARAH RIZK
K090183 01/26/2009 HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON COOK ENDOSCOPY TIFFANNY THOMAS
K093619 11/23/2009 EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E COOK IRELAND LTD JACINTA KILMARTIN
K093469 11/06/2009 CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS COOK, INC. SUSANNE GALIN
K090133 01/21/2009 CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS COOK, INC. KAREN BRADBURN
K090128 01/21/2009 TAC-TITE (TM) CORE ESSENCE ORTHOPAEDICS, INC. SHAWN T HUXEL
K093472 11/06/2009 TRINITY ACETABULAR SYSTEM CORIN U.S.A. ASHLEA BOWEN
K090054 01/13/2009 ATLAS IMPLANT SYSTEM - WIDE PLUS COWELLMEDI CO., LTD JUNG BAE BANG
K090049 01/13/2009 ATLAS IMPLANT SYSTEM- MINI PLUS COWELLMEDI CO., LTD JUNG BAE BANG
K093480 11/09/2009 CUATTRO UNOMD CUATTRO, LLC MARK SKEELS
K090106 01/01/2009 PRELUDE ONE DANVILLE MATERIALS, INC. LINDSAY TILTON
K090007 01/02/2009 JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. QING WANG
K090124 01/21/2009 GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K093474 11/06/2009 DEPUY FRACTURE AND FUSION PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K093646 11/25/2009 DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MEYER
K090073 01/12/2009 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K093415 11/02/2009 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K093492 11/11/2009 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K090104 01/15/2009 LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DIASORIN, INC. KELLY R SAUER
K093498 11/12/2009 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DIASORIN, INC. CAROL A DEPOUW
K093680 11/27/2009 DIAZYME CYSTATIN C ASSAY DIAZYME LABORATORIES ABHIJIT DATTA
K083712 01/22/2009 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS DIPURE, LLC. TIM MARCO
K090062 01/09/2009 WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC DIANA HONG
K093587 11/19/2009 DENTAL MERCURY DMG USA, INC. PAMELA PAPINEAU
K090055 01/08/2009 LOW & HIGH SPEED KIT DPM USA CORP. GEORGE ECHEVERRI
K090171 01/23/2009 COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D E-WOO TECHNOLOGY VINCENT LEE
K090203 01/27/2009 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS EBI, L.P. VIVIAN KELLY
K093465 11/10/2009 FUSION SYSTEM ECLIPSEMED GLOBAL, INC IGOR GRADOV
K093554 11/21/2009 RETROFLEX DILATOR KIT EDWARDS LIFESCIENCES, LLC. JASON K LYON
K090045 01/07/2009 COLOR LCD MONITOR, RADIFORCE RX320 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K090064 01/09/2009 EMINENT SPINE INTERBODY FUSION SYSTEM EMINENT SPINE DAVE FREEHILL
K093622 11/23/2009 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 ENCISION, INC. JUDITH V KING
K090109 01/15/2009 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD EPOCAL, INC. ROY LAYER
DEN090008 01/05/2009 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL Kevin Walls
K093613 11/23/2009 VASCUVIEW TAP ULTRASOUND SYSTEM ESCALON MEDICAL CORP. ROGER EDENS
K093681 11/27/2009 MERIDIAN GUIDEWIRE EV3 NEUROVASCULAR DEBORAH BAKER-JANIS
K093430 11/03/2009 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. EXACTECH, INC. GRAHAM CUTHBERT
K083838 01/10/2009 SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES FOOK TIN TECHNOLOGIES LIMITED JOHN CHAI
K090126 01/21/2009 FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, FOTONA D.D. STOJAN TROST
K093427 11/03/2009 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K090116 01/23/2009 FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 FUJINON, INC. MASAYUKI OOYATSU
K093608 11/20/2009 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K090212 01/28/2009 MAC 800 RESTING ECG ANALYSIS SYSTEM GE MEDICAL SYST. INFORMATION TECHNOLOGIES LARRY LEPLEY
K093514 11/13/2009 DISCOVERY MODEL NM/CT 670 GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K093581 11/18/2009 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
K093694 11/30/2009 GERATHERM UNIQUERESC GERATHERM MEDICAL AG ANDREA PECSI
K090191 01/27/2009 HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB HANDYLAB, INC MARTHA J RUMFORD
K090026 01/05/2009 CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K093575 11/18/2009 GLUMA DESENSITIZER POWER GEL HERAEUS KULZER, LLC CHERYL V ZIMMERMAN
K093466 11/06/2009 HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGH THISTLETHWAITE
K090132 01/23/2009 MAXMORESPINE SPINAL SYSTEM HOOGLAND SPINE PRODUCTS GMBH BORIS MIKLITZ
K090108 01/15/2009 HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR HOVEROUND CORP. TONY DIGIOVANNI
K093644 11/25/2009 RESTORATION ADM SYSTEM X3 ACETABULAR HOWMEDICA OSTEONICS CORP. AVITAL MERL MARGULIES
K093433 11/04/2009 VARIAX ELBOW SYSTEM PLATE LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K093639 11/24/2009 SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 HUVITZ CO., LTD. MATEW J WESS
K093475 11/06/2009 BASESENS BLOOD GLUCOSE MONITORING SYSTEM HYGEIA, INC. ROBERT J BARD
K090074 01/21/2009 HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS HYGIA HEALTH SERVICES, INC. JEROME JAMES
K090189 01/26/2009 ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE ICU MEDICAL, INC TRACY BEST
K090234 01/30/2009 SPECTRA SYSTEM DENTAL IMPLANTS 2008 IMPLANT DIRECT LLC THOMAS GOTTENBOS
K090159 01/22/2009 INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES INCISIVE SURGICAL, INC. JAMES PETERSON
K093545 11/17/2009 PINPOINTE FOOTLASER MODEL 6W, 30W, 100W INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) ANNE WORDEN
K090177 01/23/2009 INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE INION OY KATI MARTTINEN
K093564 11/18/2009 SVED WOUND TREATMENT SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K093669 11/27/2009 SEC IBF CAGE INNVOTEC SURGICAL, INC. JUSTIN EGGLETON
K093399 11/02/2009 PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 INRAD MELISSA LALOMIA
K093683 11/30/2009 ORTHOPANTOMOGRAPH OP300 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY MATTI TULIKOURA
K093623 11/23/2009 GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K090209 01/28/2009 HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K090192 01/27/2009 BILI BLUE F20T12/BBY AND F40T12/BBY INTERLECTRIC CORP. KEN C FRAZIER
K093642 11/24/2009 NEUTRASAL INVADO PHARMACEUTICALS EDWARD D KOBUS
K090070 01/12/2009 INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM INVUITY, INC. KIT CARIQUITAN
K090078 01/12/2009 KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT IOP, INC. JASON MALECKA
K090087 01/13/2009 MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM IRADIMED CORPORATION FRANCIS X CASEY
K093576 11/18/2009 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K093570 11/18/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K093637 11/24/2009 JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 JMS NORTH AMERICA CORP. E J SMITH
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K093635 11/23/2009 MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS TAIDOC TECHNOLOGY CORPORATION DEBRA LIANG
K090188 01/26/2009 U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 TAIDOC TECHNOLOGY CORPORATION YUHUA CHEN
K090020 01/05/2009 BEL-CYPHER, MODEL Y977 TAKARA-BELMONT CO., LTD. KUNIHIKO SOBUE
K090081 01/12/2009 TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS TALLADIUM ESPANA S.L. DIANE HORWITZ
K093641 11/24/2009 TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM TANGO3, LLC LORI HOLDER
K093439 11/04/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN PUFA PLASTIC PRODUCTS CO., LTD. JOHN ZHAO
K090040 01/06/2009 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) TERUMO MEDICAL CORP. MARK UNTERREINER
K093497 11/12/2009 THD BANDY THD SPA GUIDO BONAPACE
K090009 01/02/2009 THD SLIDE ONE THD SPA MAUREEN O'CONNELL
K083758 01/26/2009 SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS THE ELECTRODE STORE, INC. CARL YOUNGMANN
K090154 01/22/2009 SPI DENTAL IMPLANT INICELL THOMMEN MEDICAL, AG LINDA K SCHULZ
K093615 11/23/2009 SPI DENTAL IMPLANT, ELEMENT THOMMEN MEDICAL, AG LINDA K SCHULZ
K090153 01/22/2009 SPI VARIOMULTI ANGLED ABUTMENT THOMMEN MEDICAL, AG LINDA K SCHULZ
K093546 11/17/2009 SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX TOGO MEDIKIT CO., LTD. FUMIAKI KANAI, PH.D
K090115 01/21/2009 RETINA CAMERA TRC-NW7SF MARK II TOPCON CORP. TAKAO SUGAWARA
K090076 01/12/2009 SALTO TALARIS TOTAL ANKLE PROSTHESIS TORNIER SEVERINE BONNETON
K090139 01/30/2009 ANKLE ARTHRODESIS PLATE SYSTEM TORNIER, INC. BRAHIM HADRI
K090158 01/22/2009 APLIO ARTIDA V2.0 SSH-880CV TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K090220 01/29/2009 COLON VIEW, MODEL CSCV-001A TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K093676 11/27/2009 OMNITECH LARGE, TRIMED COMPRESSION SCREW TRIMED, INC. KELLI ANDERSON
K093478 11/10/2009 KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM TROPHY MARIE-PIERRE LABAT-CAMY
K090065 01/09/2009 AEROCHAMBER MINI VENTILATION CHAMBER TRUDELL MEDICAL INTL. DARRYL FISCHER
K093524 11/16/2009 PIVIT A/B ST AND PIVIT A/B ST-R TYRX ,INC MARK CITRON
K090122 01/21/2009 NUOVOGUARD U.S. SAFETY SYRINGES CO., INC. CHRISTINA SMITH
K093462 11/06/2009 SONIX ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION CHAS YU
K090083 01/12/2009 CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 UNICARE BIOMEDICAL, INC. STAN YANG
K093400 11/02/2009 1ML UNITRACT INSULIN SYRINGE 27G X 1/2" AND 29G X 1/2" UNILIFE MEDICAL SOLUTIONS LIMITED MELISSA L DEHASS
K093653 11/25/2009 URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK URESIL, LLC LEV MELINYSHYN
K093527 11/16/2009 ARIA RADIATION ONCOLOGY WITH MIRS VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K093502 11/12/2009 VARI-LASE ENDOVENOUS LASER CONSOLE VASCULAR SOLUTIONS, INC. JENNIFER RUETHER
K093503 11/12/2009 INTRAX FILM PROCESSOR VELOPEX INTERNATIONAL, INC. ANTHONY URELLA
K093525 11/18/2009 ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE VENTLAB CORP. JAMES A COCHIE
K093617 11/23/2009 VENTLAB 6000 SERIES HUMIDIFIER VENTLAB CORP. JAMES A COCHIE
K090214 01/29/2009 VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND VERATHON INCORPORATED KRISTIAN NIELSEN
K090180 01/27/2009 TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE VERMED, INC. MARC FILLION
K093675 11/27/2009 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K090221 01/30/2009 REACTION SYSTEM VIORA LTD. JOSEF LUZON
K093446 11/06/2009 VITA VMK MASTER VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. ELIZABETH WOLFSEN
K090157 01/27/2009 ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. WCM WASTE & COMPLIANCE MANAGEMENT, INC. SARA BETH WATSON
K090156 01/22/2009 ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 WCM WASTE & COMPLIANCE MANAGEMENT, INC. SARA BETH WATSON
K093500 11/12/2009 POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE WEAR SAFE (MALAYSIA) SDN. BHD. S.H. TAN
K090066 01/09/2009 POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE WEAR SAFE (MALAYSIA) SDN. BHD. S.H. TAM
K090023 01/05/2009 IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K090140 01/21/2009 GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER WILLIAM COOK EUROPE APS MOLLY BUSENBARK
K093508 11/12/2009 RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) WOMANCARE GLOBAL SUSANNE PARKS
K093552 11/17/2009 EVOLUTION MP TOTAL KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. RYAN ROSS
K093405 11/02/2009 PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES WRIGHT MEDICAL TECHNOLOGY, INC. SARAH HOLTGREWE
K090199 01/27/2009 JIAJIAN ACUPUNCTURE NEEDLE WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. DORIS DONG
K090198 01/27/2009 JIAJIAN SELF-ADHESIVE ELECTRODE WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. DORIS DONG
K090224 01/30/2009 FORTEX PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN
K093591 11/19/2009 STIMPOD MODEL NMS-400 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. BRIAN ROTHMAN
K090058 01/08/2009 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB YA HORNG ELECTRONIC CO., LTD. JEN KE-MIN
K090094 01/15/2009 ZELTIQ SYSTEM ZELTIQ AESTHETICS DONALD V JOHNSON
K090027 01/05/2009 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
K093561 11/18/2009 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM ZIMMER, INC. BENJAMIN CURSON, CQE RAC


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