FDA 510(k) Decisions During November, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K102953 11/04/2010 HEPARIN DOSE RESPONSE CARTRIDGE MEDTRONIC INC. JEFFERY L KOLL
K102377 11/18/2010 VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 A PLUS MEDICAL THOMAS C LOESCHER
K102234 11/24/2010 A-DEC 200 DENTAL SYSTEM A-DEC, INC. THOMAS H LOUISELL
K103165 11/10/2010 BLOOD SAMPLING SET ACACIA, INC. FERGIE FERGUSON
K102650 11/17/2010 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K101794 11/29/2010 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA ADVANCED SURGICAL CONCEPTS ROSINA ROBINSON
K102240 11/10/2010 NIVO NEBULIZER SYSTEM AEROGEN IRELAND, LTD. CAITRIONA CONNEELY
K102505 11/24/2010 HTO PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K103003 11/09/2010 AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K101755 11/22/2010 AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC WILLIAM Y.S. HUNG
K101285 11/12/2010 CONSTELLATION VISION SYSTEM ALCON MANUFACTURING, LTD. MARTIN KAUFMAN
K102820 11/05/2010 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY ALPHATEC SPINE, INC. KARLA SCHAFFNER
K101654 11/10/2010 IMPROVIS IMAGING SYSTEM AMERICAN DENTAL PARTNERS, INC TIMOTHY RODENBERGER
K093495 11/19/2010 OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS AMERICAN DIAGNOSTIC CORP. MICHAEL FALCO
K101220 11/05/2010 EXPLORER 4D TREATMENT PLANNING SYSTEM AMERICAN RADIOSURGERY, INC. DAN OLIVER
K102690 11/24/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K102930 11/03/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K102631 11/04/2010 KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K100199 11/26/2010 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K103282 11/16/2010 LAPAROSCOPIC DISSECTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K101291 11/23/2010 SCANVIEW HER2/NEU FISH SYSTEM APPLIED SPECTRAL IMAGING, LTD. DAN LAOR
K101574 11/23/2010 ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K103057 11/19/2010 ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K101174 11/12/2010 ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 ATRICURE, INC. JAMES LUCKY
K101882 11/03/2010 PRONTOSAN ANTIMICROBIAL WOUND GEL B. BRAUN MEDICAL, INC. MATTHEW J HOMA
K102146 11/18/2010 BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. ISMAIL KILIC
K100607 11/18/2010 COULTER 4C-EX 300 CELL CONTROL BECKMAN COULTER, INC. LOURDES COBA
K102073 11/08/2010 MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS BENLAN, INC. E.J. SMITH
K101105 11/10/2010 POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K101106 11/10/2010 POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K093758 11/17/2010 BGM GALECTIN -3 BG MEDICINE, INC. CAROL ADILETTO
K100246 11/24/2010 MAX-IF1000 BIO PROTECH, INC. JUDY BURTON
K100565 11/16/2010 DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 BIO-DETEK, INC. ROBERT MORSE
K100917 11/03/2010 FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K102668 11/17/2010 ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML BIOMERIEUX ASA KARLSSON
K101582 11/08/2010 CAM STRUCTSURE BARS BIOMET 3I, INC. JOSE E CABRERA
K092541 11/09/2010 INTERFACE BIOSTRUCTURES DAVE BALDING
K102527 11/05/2010 IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER BOSTON SCIENTIFIC CORPORATION DANIEL HOAR
K102880 11/19/2010 BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) BRIGHTWAY HOLDINGS SDN. BHD. NADARAJAN VENUGOPAL
K102409 11/04/2010 DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 BYRNE MEDICAL INC. JOHN WILLIS
K102581 11/08/2010 DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 BYRNE MEDICAL INC. JOHN WILLIS
K102855 11/19/2010 UNIVERSAL IRRIGATION SOLUTION HYBRID BYRNE MEDICAL, INC. JOHN WILLIS
K102159 11/17/2010 POWERPICC SV CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K102500 11/04/2010 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH, INC. TATYANA BOGDAN
K102147 11/19/2010 CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 CARDIOQUIP LLP DOUGLAS PLATT
K103090 11/19/2010 SPECTRA OPTIA R APHERESIS SYSTEM CARIDIANBCT, INC. PATTI ARNDT
K101182 11/03/2010 IOLMASTER 500 CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K100721 11/23/2010 LOCKING BONE SCREW MODEL HCQ04, HCZ04 CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD. DIANA HONG
K101400 11/09/2010 LOCKING COMPRESSION PLATE CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. DIANA HONG
K102669 11/17/2010 DIODE LASER THERAPY SYSTEM CHINA DAHENG GROUP, INC. DIANA HONG
K102204 11/15/2010 CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM CHOICE SPINE, LP TODD HAWKINS
K103215 11/15/2010 CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT CIANNA MEDICAL GARY MOCNIK
K102657 11/17/2010 CONCENTRIC BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K101534 11/24/2010 CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM CONMED CORP. SHAWN REIDEL
K102339 11/23/2010 CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE CONMED LINVATEC JAN FLEGEAU
K093472 11/23/2010 TRINITY ACETABULAR SYSTEM CORIN U.S.A. ASHLEA BOWEN
K103052 11/10/2010 V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE COVIDIEN LLC JENNIFER BRENNAN
K103263 11/22/2010 ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H FRANK GIANELLI
K102337 11/08/2010 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE CURON SCIENTIFIC CO., LTD PETER WANG
K102236 11/18/2010 HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L SUSAN PAVELKO
K100628 11/24/2010 PLASMALUXLS DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K102308 11/22/2010 SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS DENTIUM CO., LTD. EUNKYUNG SON
K102080 11/23/2010 DEPUY RECLAIM REVISION HIP SYSTEM DEPUY (IRELAND) RHONDA MYER
K103100 11/17/2010 MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. EUGENE BANG
K101762 11/15/2010 VIPER F2 FACET FIXATION SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K102638 11/30/2010 DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS DIAZYME LABORATORIES ABHIJIT DATTA
K100100 11/10/2010 DIO STEADY EXTERNAL IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K102603 11/17/2010 SA FLOWABLE ADHESIVE DMG USA, INC. PAMELA PAPINEAU
K102255 11/23/2010 DMP ETCHING GEL DMP LTD DIMITRIS PRANTSIDIS
K102254 11/23/2010 DMP SINGLE BONDING DMP LTD DIMITRIS PRANTSIDIS
K102257 11/19/2010 NANOCERAM- BRIGHT DMP LTD DIMITRIS PRANTSIDIS
K101133 11/18/2010 SENSOMETRICS SOFTWARE DPCOM AS CONSTANCE BUNDY
K101368 11/18/2010 D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES DRAGON HEART MEDICAL, INC. JINA YU
K100487 11/29/2010 EQUINOX CO2 LASER SYSTEM ECLIPSEMED GLOBAL, INC CONNIE HOY
K102531 11/17/2010 MUCOGRAFT ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE PETER S REICHERTZ
K100797 11/10/2010 FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS EDAN INSTRUMENTS, INC. JIGAR SHAH
K101539 11/24/2010 VITAL SIGNS MONITOR MODEL M3B EDAN INSTRUMENTS, INC. RANDY JIANG
K102200 11/04/2010 INTEGRITY MODEL 1014284 ELEKTA LTD. ANDREW HEDGES
K102343 11/23/2010 EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM EMERGE MEDICAL CURTIS RAYMOND
K102202 11/23/2010 GS 3000 EMSI CHERITA JAMES
K101940 11/19/2010 EQUASHIELD SYSTEM PROTECTIVE PLUS EQUASHIELD MEDICAL LTD ELISSA BURG
K102215 11/09/2010 KIRSCHNER WIRES, STEINMAN PINS EVERGREEN ORTHOPEDIC RESEARCH LAB WAYNE MORSE
K103012 11/10/2010 EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS EXACTECH, INC. LINDY KNISELY
K102951 11/04/2010 EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) EXACTECH, INC. GRAHAM L CUTHBERT
K102975 11/05/2010 NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE EXACTECH, INC. VLADISLAVA ZAITSEVA
K102487 11/08/2010 NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 EXACTECH, INC. VLADISLAVA ZAITSEVA
K102519 11/22/2010 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN, III
K102170 11/24/2010 SIMPLEXA FLU A/B & RSV FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K102548 11/26/2010 FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE FOOTPRINT MEDICAL INC. CLYDE N BAKER
K102245 11/09/2010 CARE ZY5BA OXYGEN CONCENTRATOR FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. KATHY GUO
K101817 11/22/2010 LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N FOTONA D.D. STOJAN TROST
K093599 11/24/2010 ARROW ANATOMICAL SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K093071 11/17/2010 FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 FUNDUS PHOTO, LLC DALE BRODSKY
K100364 11/03/2010 GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K102388 11/04/2010 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K102393 11/05/2010 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K102231 11/03/2010 DISCOVERY NM 750B GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ELI WERNER
K102615 11/18/2010 WIRELESS DR IMAGING OPTION-WDR1 GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K102015 11/19/2010 OSTEON, OSTEON SINUS, OSTEON LIFTING GENOSS CO., LTD. EUNKYUNG SON
K102048 11/09/2010 ATRAUMATIC VASCULAR CLAMPS GEOMED MEDIZIN- TECHNIK GMBH & CO. KG HARALD JUNG
K101784 11/26/2010 MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX GREATBATCH MEDICAL KRISTI FOX
K102540 11/16/2010 PTFE PORTABLE INTRODUCER GREATBATCH MEDICAL KRISTI FOX
K103041 11/09/2010 VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K102074 11/02/2010 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) GX CORPORATION SDN BHD CHO S FONG
K102546 11/17/2010 CHITOGAUZE HEMCON MEDICAL TECHNOLOGIES, INC. KENDRA RATHKEY
K101547 11/22/2010 HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) HENKE-SASS WOLF, GMBH. LYNETTE HOWARD
K094016 11/19/2010 NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H HINSON AND HALE MEDICAL TECHNOLOGIES, INC JEFFREY O STULL
K103184 11/10/2010 SILK'N FLASH N GO HOME SKINOVATIONS LTD. AMIR WALDMAN
K103104 11/22/2010 SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT HOWMEDICA OSTEONICS CORP AVITAL MERL-MARGULIES
K103118 11/19/2010 REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR HOYA PHOTONICS, INC. DONNA TEMPLEMAN
K101912 11/10/2010 THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 HUBDIC CO., LTD PETER CHUNG
K102360 11/29/2010 ICESENCE 3 ICECURE MEDICAL LTD. ELISABETH SADKA
K102791 11/23/2010 EASYSUITE SURGICAL LIGHT CONTROL (ESLC) IMAGE STREAM MEDICAL, INC. BETH CYR
K103268 11/23/2010 OMNI EXPRESS INFINIUM MEDICAL JOHN OBRIEN
K102802 11/23/2010 INTEGRA ELECTRODE TUNNELING NEEDLE INTEGRA LIFESCIENCES CORPORATION DEREK CAO
K102372 11/03/2010 OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO CHEN XI
K100590 11/10/2010 EDGE CO2 LASER SYSTEM JM SYSTEM CO., LTD. SU-GUN LEE
K093054 11/15/2010 SCALP DURA RETRACTOR, MODEL KS00474 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K102994 11/03/2010 K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC. JACK PAVLO
K100720 11/18/2010 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING KAWASUMI LABORATORIES, INC. SUZAN ONEL
K102666 11/09/2010 KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM KIMBERLY-CLARK CORP. MARCIA JOHNSON
K102349 11/24/2010 AERODR SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K100888 11/15/2010 MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM LANX, INC. WILLIAM SANDUL
K102083 11/18/2010 VELSCOPE VX LED DENTAL INC. DAVID MORGAN
K101382 11/09/2010 DPL NUVE LED TECHNOLOGIES, LLC LEWIS WARD
K100407 11/05/2010 LIFE SPINE INTERSPINOUS FIXATION SYSTEM LIFE SPINE CHARLES P GILL
K102484 11/09/2010 SEQURE SNARE SYSTEM LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. SHI XIAOLI
K101031 11/18/2010 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 MASIMO CORPORATION MARGUERITE THOMLINSON
K102237 11/23/2010 PVS MODEL 1.0 MEDCOM GMBH STEFAN WALTER
K102010 11/19/2010 VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET MEDPRO SAFETY PRODUCTS, INC. H. CARL JENKINS
K102114 11/22/2010 MEDRANGE ELECTROSURGICAL GENERATOR MEDRANGE CORPORATION HARRY WOODS
K101808 11/08/2010 SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER MEDSHAPE SOLUTIONS JACK GRIFFS
K102555 11/17/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K102807 11/17/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K102072 11/03/2010 MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) MEMOMETAL TECHNOLOGIES GILLES AUDIC
K102365 11/18/2010 MICROPLEX COIL SYSTEM- COSMOS MICROVENTION, INC. LARAINE PANGELINA
K101163 11/23/2010 BIOGEL ORTHOPRO INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE USA ANGELA BUNN
K102923 11/19/2010 BARRIER N95 PARTICULATE RESPIRATOR MOLNLYCKE HEALTHCARE CAITLIN SENTER
K102433 11/18/2010 MOORVMS-PRES PRESSURE CUFF CONTROLLER MOOR INSTRUMENTS LTD. XIABING HUANG
K102112 11/18/2010 CRITICOOL PRO MTRE ADVANCED TECHNOLOGY LTD. IFAT OREN
K091360 11/03/2010 CLEARFLUX DIALYZER REPROCESSING SYSTEM NOVAFLUX TECHNOLOGIES MOHAMED E LABIB
K102583 11/02/2010 MUCHECK, VERSION 9.0 ONCOLOGY DATA SYSTEMS, INC. VINCENT RUMINER
K093055 11/22/2010 CSTS SCREW ORTHOPRO LLC J.D. WEBB
K102326 11/15/2010 PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC BARION BRACY
K102162 11/10/2010 PARCUS PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC BARTON BRACY
K100598 11/19/2010 PENRITH ELETTRA ULTRASOUND SYSTEM PENRITH CORPORATION LAWRENCE ENGLE
K102790 11/29/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG PERUSAHAAN GETAH ASAS SDN BHD S F CHO
K101538 11/05/2010 HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) PHILIPS ELECTRONICS UK LIMITED DIANA KORDA HEWITT
K102344 11/09/2010 MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K102757 11/05/2010 LIFENET SYSTEM PHYSIO-CONTROL, INC. TERESA DAVIDSON
K103269 11/23/2010 PATCHASSIST LARGE POLYTOUCH MEDICAL LTD LEO BASTA
K083746 11/10/2010 BIOSIGN FLU A+B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
K102620 11/22/2010 POWDERFREE BLACK NITRILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K102198 11/05/2010 COMPACT TOUCH STS QUANTEL MEDICAL S.A. MIKE JOHNSON M.D.
K102849 11/23/2010 ACCULMAING RADIOLOGY INFORMATION SYSTEMS, INC. E.J. SMITH
K092273 11/01/2010 RANDOX ETHANOL ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K092258 11/09/2010 RANDOX METABOLITE (EDDP) ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K092272 11/18/2010 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K101112 11/04/2010 RELIANCE SPINAL SCREW SYSTEM RELIANCE MEDICAL SYSTEMS BRET BARRY
K102068 11/16/2010 MINIATURIZE CHEST COMPRESSOR (MCC) RESUSCITATION INTERNATIONAL ROBYN SCOPIS
K102043 11/18/2010 ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER REX MEDICAL SUSAN D GOLDSTEIN- FALK
K102086 11/01/2010 ELECSYS CA 125 II CALCHECK 5 ROCHE DIAGNOSTICS KELLY FRENCH
K103162 11/18/2010 ELECSYS PTH CALCHECK 5 ROCHE DIAGNOSTICS KELLY FRENCH
K102445 11/10/2010 ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS ROSTAM LTD. ROBERT J STAAB
K100450 11/18/2010 I-ROOT S-DENTI CO., LTD. TAE KYE NAM
K101619 11/12/2010 WELCH ALLYN 1500 PATIENT MONITOR SCHILLER AG SERKAN SEZER
K100920 11/29/2010 MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES SEQUAL TECHNOLOGIES CO., LTD CEARO HUANG
K101822 11/19/2010 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS SGMP CO., LTD. JANNA P TUCKER
K101436 11/17/2010 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) SHEN WEI (USA), INC. ABLERT LI
K102865 11/03/2010 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K102988 11/09/2010 ELECTRONIC BLOOD PRESURE MONITOR SHENZHEN PANGO ELECTRONIC CO., LTD DIANA HONG
K102093 11/03/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT KATHY LIU
K102097 11/17/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT KATHY LIU
K102904 11/23/2010 ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS CLARE SANTULLI
K093626 11/29/2010 INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN A DRAY-LYONS
K100185 11/19/2010 SLEEP APP SLEEP MEDICINE NETWORK, INC. RICHARD MOORE
K102122 11/22/2010 SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 SMITH & NEPHEW, INC. CHRISTINA FLORES
K102967 11/04/2010 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 SMITH & NEWPHEW, INC SHEREEN MYERS
K101519 11/05/2010 PARIETEX PLUG AND PATCH SOFRADIM PRODUCTION JAMES MCMAHON
K102390 11/19/2010 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. JESSICA R STENBERG
K103202 11/23/2010 PREASSEMBLED SURGICAL WASH SET SORIN GROUP ITALIA S.R.L. BARRY SALL
K102983 11/01/2010 VASCUCLEAR PRECISION BIPOLAR SORIN GROUP USA, INC. SCOTT LIGHT
K102478 11/03/2010 OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING SOUTHWEST TECHNOLOGIES, INC. EDWARD I STOUT
K102682 11/30/2010 STAXX(R) XD SYSTEM SPINE WAVE, INC. ROAIADA RIZKALLAH
K102217 11/22/2010 SYSTEM 1E CHEMICAL INDICATOR STERIS CORPORATION ROBERT F SULLIVAN
K092745 11/19/2010 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU STERIS CORPORATION ROBERT F SULLIVAN
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