FDA 510(k) Decisions During July, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K091911 07/21/2009 BOLUS COMPENSATOR .DECIMAL, INC. DANIEL L BENNETT
K083903 07/15/2009 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M COMPANY JIZHONG JIN
K083377 07/27/2009 ACCUPEN ACCUTOME ULTRASOUND, INC. BRIAN T.S. BARRETT
K083419 07/16/2009 ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 ACTHERM, INC. RICHARD HSIEH
K083354 07/20/2009 FLORASEAL, MODEL FS350D ADHEZION BIOMEDICAL RICHARD JONES
K091013 07/30/2009 SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K091993 07/31/2009 RAPID PROGRAMMER, VERSION 3.3.0 ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) MIA M WARE
K083074 07/24/2009 AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT ADVANDX, INC. PAULA E BULGER
K083004 07/02/2009 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA BOYLE
K091793 07/09/2009 AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 AGA MEDICAL CORP. DIANE CARROLL
K083761 07/22/2009 ALATECH POWDER FREE LATEX EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K083812 07/09/2009 REFRESH OPTIVE LENS COMFORT REWETTING DROPS ALLERGAN, INC. BEVERLEY D VENUTI
K091219 07/09/2009 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K090779 07/07/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K091189 07/08/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K091242 07/06/2009 BANTAM ALTIMATE MEDICAL, INC. CAROLL L MARTIN
K092086 07/30/2009 AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 AMERX HEALTH CARE CORP. ART W SIMONETTI, LPN
K091997 07/30/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 ANDON HEALTH CO.,LTD LIU YI
K092045 07/30/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 ANDON HEALTH CO.,LTD LIU YI
K091500 07/31/2009 MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 ANDON HEALTH CO.,LTD LIU YI
K091966 07/30/2009 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 ANGIOSCORE, INC. KIMBERLEY KLINE
K083686 07/02/2009 BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K090850 07/30/2009 ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K090738 07/27/2009 THERMOFLO HCH, THERMOFLO FILTER ARC MEDICAL, INC. PAUL DRYDEN
K091854 07/02/2009 BIS CLICK SENSOR/CABLE ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K091783 07/07/2009 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM AVANTIS MEDICAL SYSTEMS, INC. AMRITA SETHI
K091285 07/28/2009 AL T LASER, MODEL AVI HPLL-12 AVICENNA LASER TECHNOLOGY, INC. BRUCE COREN
K083222 07/31/2009 AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE DORA
K090838 07/20/2009 STIMULUS/DISSECTION INSTRUMENTS AXON SYSTEMS, INC. HOWARD BAILIN
K083689 07/01/2009 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. LINDA MORGAN
K091274 07/14/2009 CORONIS 5MP HD, MODEL MDMG 5121 BARCO NV LIEVEN DE WANDEL
K090967 07/31/2009 BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 BD BIOSCIENCES KATY CAMPBELL
K091153 07/13/2009 SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 BECKMAN COULTER, INC. MARINE BOYAJIAN
K091377 07/02/2009 BD FLU+ SYRINGE BECTON DICKINSON & CO. EILEEN HILLER
K091670 07/01/2009 BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER BECTON DICKINSON & CO. JUSTICE ALDER
K090434 07/06/2009 BECE PRESS BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO MICHAEL ESSLER
K090599 07/20/2009 MD300K1 PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K091855 07/01/2009 THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 BELMONT INSTRUMENT CORP. URAIWAN LABADINI
K090389 07/14/2009 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. JEN KE-MIN
K083105 07/24/2009 KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K090847 07/01/2009 PLATELIA TOXO IGM KIT MODEL 26211 BIO-RAD LABORATORIES PRIYA BONDRE
K090699 07/27/2009 VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 BIO-RAD LABORATORIES, INC. JACKIE H BUCKLEY
K091922 07/14/2009 WATERLASE C100, MODEL 7100104 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K091024 07/17/2009 CHROMID MRSA AGAR, MODEL: REF 43 841 BIOMERIEUX, INC. NANCY WEAVER
K091058 07/22/2009 ADKINS STRUT BIOMET MICROFIXATION, INC. KIM REED
K091067 07/14/2009 5.5 POLARIS SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K091558 07/17/2009 BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM BIOPTICS, INC. CARLOS REYES
K090554 07/02/2009 ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE BOSTON SCIENTIFIC CORP. STACEY A STRAND
K091816 07/01/2009 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION JANIS TARANTO
K082982 07/20/2009 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
K083094 07/07/2009 STREAMER POLYMER GUIDEWIRE BRIVANT, LTD. TOMAS FUREY
K090851 07/02/2009 DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) BYRNE MEDICAL INC. JENNIFER JAMES
K090735 07/06/2009 C.T.M. MOBILITY SCOOTER, HS-528 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K091418 07/06/2009 C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION C.T.M. HOMECARE PRODUCT, INC. LINDA BOVARD
K091300 07/23/2009 ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 CAO GROUP, INC. ROBERT LARSON
K091308 07/09/2009 ALARIS PC UNIT, MODELS 8000 AND 8015 CARDINAL HEALTH 303, INC. MICHELLE J BADAL
K090211 07/01/2009 INFLATABLE BONE TAMP CARDINAL HEALTH, INC. SHARON NICHOLS
K091889 07/20/2009 DRX-EVOLUTION, MODEL VX3733-SYS CARESTREAM HEALTH, INC. CAROLYN WAGNER
K091380 07/30/2009 CORDCAP CENTRIX, INC. JOHN DISCKO
K091109 07/09/2009 XPERT C. DIFFICILE CEPHEID RUSSEL K ENNS
K082629 07/01/2009 S12X WITH ESAX OPTION CHATTEN ASSOCIATES, INC. JOHN B CHATTEN
K083913 07/31/2009 CHESSON LABS LIQUID BANDAGE CHESSON LABORATORY ASSOCIATES, INC. SCOTT E NEUVILLE
K090646 07/23/2009 CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 CHEST M.I., INC. JEAN ASQUITH
K091179 07/16/2009 MONACO RTP SYSTEM, VMAT OPTION COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K091961 07/30/2009 MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K091355 07/22/2009 DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 CONMED ENDOSCOPIC TECHNOLOGIES, INC. KAREN PROVENCHER
K090688 07/10/2009 COOK UROLOGICAL GRAFT COOK BIOTECH, INC. MARY A FADERAN
K090709 07/07/2009 CORTEX DENTAL IMPLANT SYSTEM CORTEX DENTAL IMPLANTS INDUSTRIES, LTD BENNY AZARY
K091900 07/16/2009 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES REBECCA RONNER
K090054 07/29/2009 ATLAS IMPLANT SYSTEM - WIDE PLUS COWELLMEDI CO., LTD JUNG BAE BANG
K082849 07/16/2009 SILENT SLEEP CRANIOFACIAL PAIN CENTER OF IDAHO JAMISON R SPENCER
K091482 07/06/2009 HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD JIUGUANG (JOE) SONG
K090007 07/24/2009 JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. QING WANG
K091834 07/15/2009 PASSPORT V MONITOR, MODEL 0998-00-6100 DATASCOPE CORP., PATIENT MONITORING DIVISION KATHLEEN KRAMER
K090256 07/06/2009 POWER STANDING DANI DAVISMADE, INC. DANIEL DAVIS
K092030 07/24/2009 ELATION MB METAL REINFORCED PLASTIC BRACKET DENTSPLY INTERNTIONAL HELEN LEWIS
K091751 07/14/2009 DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K092122 07/27/2009 GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K091294 07/24/2009 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K091760 07/20/2009 DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) DERMAPORT, INC JENNIFER HESSEL
K083712 07/10/2009 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS DIPURE, LLC. TIM MARCO
K091700 07/09/2009 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC CHRISTINE OTIS
K091747 07/01/2009 FLAATZ 500 DRTECH CORP. BEOM-JIN MOON
K091397 07/08/2009 ECSCOPE 200 DYANSYS, INC. SRINI NAGESHWAR
K090203 07/30/2009 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS EBI, L.P. VIVIAN KELLY
K090523 07/01/2009 POLARIS SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K091513 07/24/2009 SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 EDAN INSTRUMENTS, INC. WILLIAM STERN
K081998 07/09/2009 H-WAVE SPORT ELECTRONIC WAVEFORM LABORATORY, INC. RYAN P HEANEY
K090972 07/20/2009 LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K091832 07/22/2009 ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER ENDOGASTRIC SOLUTIONS, INC. STEVE HOFFMAN
K083461 07/24/2009 IMAGINE TC SKIN THERAPY SYSTEM ENDYMION MEDICAL LTD YORAM LEVY
K091681 07/08/2009 FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) ENTELLUS MEDICAL, INC. DEBORAH I NEYMARK
K090438 07/24/2009 REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR ENVITEC-WISMAR GMBH STEPHEN GORSKI
K090867 07/30/2009 AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 EP DYNAMICS, INC. ALBERT REGO
K091229 07/31/2009 GLUCOMANAGER DATA MANAGEMENT SOFTWARE EPS BIO TECHNOLOGY CORP. Y.C. LEI
K091054 07/27/2009 WALK400H ET MEDICAL DEVICES SPA LUIGO BUCCHI
K083052 07/28/2009 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) EUROIMMUN US INC KATHRYN KOHL
K083670 07/23/2009 UNIVERSAL, AESTHETICA, NATEA, NATURA EUROTEKNIKA EMMANUEL MONTINI
K091596 07/02/2009 EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC CINDY MORROW
K083870 07/30/2009 EXSALT SD7 WOUND DRESSING EXCITON TECHNOLOGIES INC. SANDRA REIS
K091577 07/24/2009 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K091163 07/22/2009 PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST FIAB SPA ALBERTO CALABRO
K091723 07/06/2009 FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 FREEDOM SCIENCES, LLC EDWARD A KROLL
K091727 07/06/2009 MEDICAL TREATMENT CHAIR, T400, T500,T600 FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. RAM KAMATH
K091388 07/22/2009 GCUC-505 GC AMERICA, INC. MARK HEISS
K091594 07/29/2009 HEART-EXERCISE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH PATRICIA TAIGE
K083421 07/24/2009 MR-TOUCH OPTION GE MEDICAL SYSTEMS, LLC DANIEL BIANK
K091536 07/17/2009 OPTIMA MR450W GE MEDICAL SYSTEMS, LLC MARK STAUFFER
K083131 07/30/2009 MEDOS HILITE RESERVOIR, MODEL: 4030 GISH BIOMEDICAL, INC. JANET PEETS
K091405 07/29/2009 PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT GIVEN IMAGING LTD. TIM THOMAS
K081923 07/01/2009 ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD GLAXOSMITHKLINE CONSUMER HEALTHCARE ZINATARA A MANJI
K090952 07/14/2009 ZYFUSE FACET FIXATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K091519 07/28/2009 HAEMOBAND MULTI-LIGATOR HAEMOBAND SURGICAL LTD. PAUL DRYDEN
K091881 07/01/2009 RPL/CPL VERTICAL PLATFORM LIFTS HARMAR SUMMIT LLC KEVIN KAMINSKI
K091390 07/30/2009 HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 HDC S.R.L. GUIDO BONAPACE
K081603 07/24/2009 DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 HEARTFORCE MEDICAL, INC. ARTHUR WARD
K091690 07/28/2009 SHARP CHUTE HEATHROW SCIENTIFIC, LLC PETE HADJIS
K091491 07/31/2009 HERO VASCULAR ACCESS DEVICE HEMOSPHERE INC W. ALLEN PUTNAM
K091494 07/31/2009 FLEXITIME FLOW HERAEUS KULZER, INC. CHERYL ZIMMERMAN
K083183 07/16/2009 AKLARUS PHOTOTHERAPY SYSTEM HILL LABORATORIES CO. BRADY ALLER
K091378 07/02/2009 MAMMOSITE II RADIATION THERAPY SYSTEM HOLOGIC, INC. JENNIFER SULLIVAN
K091185 07/24/2009 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER HSINER CO., LTD. TOM SHANKS
K090285 07/15/2009 SONICAID FM820 AND FM830 ENCORE HUNTLEIGH HEALTHCARE LTD. GRAHAM BOOTH
K091687 07/07/2009 PACSMATE, MODEL MMD-4300C/MMD-4300CX IEI TECHNOLOGY CORP. JENNIFER REICH
K091021 07/15/2009 MODIFICATION TO MEDICOMPASS CONNECT IMETRIKUS, INC. MICHAEL ACOSTA
K090579 07/07/2009 SMARTSCREENER-PLUS2 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K090406 07/22/2009 EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE INTERACOUSTICS AS HANNE NIELSEN
K091075 07/21/2009 ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM IRHYTHM TECHNOLOGIES, INC. MICHAEL RIGHTER
K090941 07/17/2009 ADHESE ONE F IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K091985 07/24/2009 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K091141 07/24/2009 THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS KNIT-RITE, INC. JEFFREY C DALBEY
K091683 07/02/2009 KOWA VX-10 A KOWA CO. LTD. AKIHIRO FUJITA
K090830 07/21/2009 LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP LABORIE MEDICAL TECHNOLOGIES, LTD. BARBARA MORNET
K091088 07/14/2009 LDR SPINE CERVICAL INTERBODY FUSION SYSTEM LDR SPINE USA NOAH BARTSCH
K090879 07/23/2009 INSUFLOW CO2IONSHIELD LEXION MEDICAL, LLC. BERNARD HORWATH
K090320 07/22/2009 CONQUEST SPINAL SYSTEM LIFE SPINE MURALI AUDIPUDY
K090766 07/23/2009 LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER LIFELOC TECHNOLOGIES, INC. MARK LARY
K090844 07/30/2009 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. MARIE LIN
K090802 07/07/2009 TIGRT MLC, TIGRT DMLC LINATECH, LLC JONATHAN YAO
K090893 07/15/2009 TIGRT TPS LINATECH, LLC JONATHAN YAO
K091236 07/30/2009 MANTRA COMBO, MODEL MECS 320 MANTRA INTL. (HK) LTD. BRENT REIDER
K083719 07/30/2009 LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K091057 07/09/2009 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION MARGUERITE THOMLINSON
K090165 07/09/2009 RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 MASIMO CORPORATION MARGUERITE THOMLINSON
K091474 07/09/2009 EASY.TOUCH INSULIN SYRINGE MASTERS HEALTHCARE, LLC. DANIEL KAMM
K090988 07/10/2009 GMK TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K090983 07/01/2009 APTUS 2.0/2.3 FOUR CORNER FUSION PLATE MEDARTIS AG KEVIN A THOMAS
K091479 07/13/2009 APTUS FOOT SYSTEM MEDARTIS AG LINDA SCHULZ
K091586 07/23/2009 VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN MEDCOMP JEAN CALLOW
K090734 07/17/2009 EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES MEDICA CORP. PHOTIOS MAKRIS
K083658 07/07/2009 PACS PLUS 5TH EDITION MEDICAL STANDARD CO., LTD. BRANDON CHOI
K092023 07/28/2009 NAVIJECT SUB2-1P, MODEL: LP604430 MEDICEL AG GEORGE MYERS
K083810 07/31/2009 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K090245 07/23/2009 SOLO INSULIN PATCH PUMP MEDINGO LTD. ARAVA HACOHEN
K092159 07/28/2009 ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. SHIM KYUNG-AM
K090707 07/15/2009 TALOS INTERVERTEBRAL BODY FUSION DEVICE MEDITECH ADVISORS, LLC JANET M WEBB
K091454 07/24/2009 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K091442 07/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK BRAD SHEALS
K091882 07/08/2009 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM MICROVENTION, INC. NAOMI GONG
K091866 07/20/2009 PROGENY VANTAGE PANORAMIC X-RAY SYSTEM MIDMARK ALAN KREMA
K090670 07/07/2009 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER MIDMARK CORP. GARY BENNING
K090792 07/06/2009 MITAKA UNIARM MITAKA KOHKI CO., LTD. MAXWELL STURGIS
K091180 07/14/2009 MINITAPE URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. CAROLINE STRETTON
K091178 07/31/2009 MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15" TOUCH SCREEN MTP MEDICAL TECHNICAL PROMOTION GMBH YVONNE FERNANDEZ
K083294 07/24/2009 VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST NANOSPHERE, INC GREGORT W SHIPP
K091645 07/21/2009 GOLD ANCHOR NASLUND MEDICAL AB TOMAS NASLUND
K090527 07/14/2009 SINUS QUICK IT SYSTEM NEOBIOTECH CO., LTD. JUNG BAE BANG
K090825 07/16/2009 SQ IS SYSTEM NEOBIOTECH CO., LTD. EUGENE BANG
K083154 07/10/2009 NEWDEAL HALLU LOCK PLATE SYSTEM NEWDEAL SAS JUDITH O'GRADY
K091788 07/29/2009 PANTA NAIL (DIA. 10MM), PANTA NAIL XL NEWDEAL SAS JUDITH O'GRADY
K090918 07/30/2009 NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER NFOCUS NEUROMEDICAL, INC. BOB FOUNDS
K091515 07/09/2009 SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM NOVADAQ TECHNOLOGIES, INC. JOHN FENGLER
K091422 07/30/2009 NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) NOVAPRO CO., LTD. ZHENZHONG CHENG
K091421 07/23/2009 NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) NOVAPRO CO., LTD. ZHENZHONG CHENG
K090981 07/02/2009 MODIFICATION TO: NUVASIVE SPHERX SYSTEM NUVASIVE, INC. HAN FAN
K091502 07/22/2009 NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. HAN FAN
K083594 07/21/2009 EZ HSG CATHETER.FOAMSEAL CATHETER OBG PRODUCTS AL MUZZAMMEL
K091444 07/20/2009 PERFSCAPE OLEA MEDICAL NEAL KOLBER
K090210 07/29/2009 MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K091403 07/29/2009 MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY ONCOLOGY TECH, LLC SEAN COMER
K091829 07/28/2009 PLS PORTABLE LIGHT SOURCE OPTIM, INC. ROBERT KRUPA
K091666 07/15/2009 PASCAL PHOTOCOAGULATOR, PASCAL-US OPTIMEDICA CORPORATION DARLENE CROCKETT-BILLIG
K090587 07/17/2009 STARLIGHT ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K090901 07/06/2009 ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 OSMETECH MOLECULAR DIAGNOSTICS ROBERT S DICHECK
K090522 07/02/2009 OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM OSTEOMED L.P. ALMA RELJA
K090996 07/29/2009 PONTO PRO OTICON MEDICAL AB KAROLIN ISBERG
K090829 07/21/2009 PARI PEP S PARI RESPIRATORY EQUIPMENT, INC. MICHAEL JUDGE
K090485 07/22/2009 COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 PERCUTANEOUS SYSTEMS, INCORPORATED THOMAS LAWSON
K083130 07/09/2009 NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 PERKINELMER, INC. KAY A TAYLOR
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