FDA 510(k) Decisions During August, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K091059 08/13/2009 FOXQ 980 LASER A.R.C. LASER GMBH KIRSTEN PAULSON
K083250 08/18/2009 NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS AA NEUROMED CORP. HERMANN DOLKER
K090358 08/06/2009 ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 ABBOTT LABORATORIES INC JUDI WALLACH
K092286 08/27/2009 FOX SV PTA CATHETER ABBOTT VASCULAR NADINE SMITH
K091827 08/18/2009 S. AUREUS PNA FISH ADVANDX, INC. PAULA E BURGER
K092238 08/11/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K090169 08/18/2009 SPECTRA FLUORESCENCE CARIES DETECTION DEVICE AIR TECHNIQUES, INC. NATALYA VALERIO
K091333 08/03/2009 S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 ALFA WASSERMANN, INC. HYMAN KATZ
K091995 08/07/2009 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K090571 08/13/2009 ALMA LASERS ALEX755 MODULE ALMA LASERS LTD. HOWARD KELLY
K091548 08/07/2009 AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEXANDER B HENDERSON
K091460 08/06/2009 ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K091699 08/10/2009 AMSURE HYDROPHILIC LATEX FOLEY CATHETER AMSINO INTERNATIONAL, INC. JESUS FARINAS
K091306 08/21/2009 AMSURE PVC INTERMITTENT CATHETER AMSINO INTERNATIONAL, INC. HOLIVEN JI
K091737 08/18/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 ANDON HEALTH CO.,LTD LIU YI
K091738 08/18/2009 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD ANDON HEALTH CO.,LTD LIU YI
K091739 08/18/2009 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 ANDON HEALTH CO.,LTD LIU YI
K063461 08/13/2009 ANOVA CONTAINMENT DEVICE ANOVA CORPORATION CAMPBELL TUSKEY
K080564 08/14/2009 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES JEFF RYBERG
K090332 08/14/2009 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 ARKRAY FACTORY USA, INC. HAMID IDRISSI
K091844 08/28/2009 ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS ARTHREX, INC. IVETTE GALMEZ
K083707 08/03/2009 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHREX, INC. SALLY FOUST
K090107 08/06/2009 MINI TIGHTROPE ARTHREX, INC. SALLY FOUST
K091552 08/12/2009 SWITCH TRT AUDIFON GMBH & CO. KG JANE PERRONE
K090995 08/14/2009 B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K090002 08/07/2009 ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A BAXTER HEALTHCARE CORP. DONNA DJINOVICH
K091820 08/26/2009 CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM BAYER HEALTHCARE MARC HENN
K083867 08/27/2009 ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND BECKMAN COULTER, INC. TYLER FOUTCH
K091742 08/14/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K091292 08/25/2009 BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 BECTON DICKINSON AND COMPANY (BD) MARY ANN ALSBERGE
K092285 08/28/2009 PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 BEST MEDICAL CANADA LTD. MARY HERBERT
K092223 08/12/2009 MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K091899 08/14/2009 VITEK 2 GRAM NEGATIVE MEROPENEM BIOMERIEUX, INC. NANCY WEAVER
K091976 08/17/2009 BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL BIOMET TRAUMA MARGARET CROWE
K092078 08/05/2009 OPTILOCK PERIARTICULAR PLATING BIOMET TRAUMA SHIKHA GOLA
K090895 08/26/2009 EKG-PLUS II SOFTWARE BIONET CO., LTD. HL JUNG
K092064 08/07/2009 SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 BIOSENSE WEBSTER, INC. MELISSA SCHULTZ
K091705 08/28/2009 PRIMER PLUS BISCO, INC. MICHELLE SCHILTZ-TAING
K090586 08/07/2009 BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) BOVIE MEDICAL RICHARD A KOZLOFF
K082886 08/10/2009 ZOOM-100DC BRAINSCOPE COMPANY, INC. MICHAEL E SINGER
K091659 08/03/2009 BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 C.R. BARD, INC. GAIL DOW
K091324 08/07/2009 SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET C.R. BARD, INC. RICK GAYKOWSKI
K091821 08/25/2009 COMMANDER 111, MODEL CD300-CD399 CARDIOCOM LLC JULIE BULVER
K091461 08/14/2009 BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE CARDIOPULMONARY CORP. JORDAN SCHRECK
K091396 08/05/2009 CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM CARDO MEDICAL CORP. DENISE DUCHENE
K091186 08/18/2009 KODAK 1500 INTRAORAL CAMERA CARESTREAM HEALTH, INC. DANIEL HOEFER
K082016 08/10/2009 GDX VCC WITH ECC SOFTWARE CARL ZEISS MEDITEC INC. JUDITH A BRIMACOMBE
K091452 08/21/2009 FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K091702 08/07/2009 CDB FLIP-SIDE-CLIP BRACKET CDB CORPORATION CHARLES VERNON
K090791 08/07/2009 DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% CENTURY PHARMACEUTICALS, INC. PAUL DRYDEN
K091251 08/25/2009 CERNER FETALINK (VERSION 1.0) CERNER CORP. SHELLEY S LOOBY
K091287 08/31/2009 VS-SENSE TEST COMMON SENSE, LTD. NATASHA LESKOVSEK
K083448 08/20/2009 CABLE, TRANSDUCER, MODEL 2400GN CONMED CORPORATION SARAH RIZK
K091856 08/07/2009 CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES CONMED CORPORATION SANDRA COVELESKI
K091648 08/05/2009 NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K090936 08/25/2009 SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K091385 08/07/2009 APPROACH HYDRO ST WIRE GUIDE, MODEL HMW COOK, INC. KAREN BRADBURN
K091971 08/27/2009 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM CORVENTIS, INC. MADHURI BHAT
K091626 08/07/2009 CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH CRYOLIFE, INC. JOHN FERROS
K091134 08/17/2009 CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE CUSTOM SPINE, INC. SAAD ATTIYAH
K091706 08/28/2009 QUATTRO PORCELAIN SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K091041 08/07/2009 RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K091453 08/12/2009 LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K091753 08/28/2009 ELVIS HSV ID AND D3 TYPING TEST SYSTEM DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K092300 08/28/2009 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K091455 08/14/2009 DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL DIAZYME LABORATORIES ABHIJIT DATTA
K091430 08/21/2009 CARE PAL, MODEL CPW-10X DIGIO2 INTERNATIONAL CO., LTD JENNIFER REICH
K091381 08/07/2009 IBEX SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K082040 08/27/2009 MINISILK FT EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K090681 08/12/2009 TANSCU O2 ELECTROCHEMICAL OXYGEN CONCEPTS, INC. CARL JENKINS
K091497 08/19/2009 K-LASER K-1200, MODEL 12 W ELTECH, S.R.L. RICHARD ALBRIGHT
K091074 08/17/2009 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES ENCISION, INC. JUDITH KING
K091481 08/18/2009 EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Y.C. LEI
K083608 08/26/2009 ERBE HYBRID KNIFE ERBE USA, INC. JOHN TARTAL
K083053 08/07/2009 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K092299 08/07/2009 TRAILBLAZER SUPPORT CATHETER EV3 INC DAVID ROBERTSON
K083302 08/03/2009 LIFECARE ELECTRODES EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K090777 08/04/2009 EZC MEDICAL, LLC INTUBAIDFLEX EZC MEDICAL, LLC PAVAN SETHI
K090576 08/12/2009 FOOTPRINT URINARY DRAINAGE CATHETER FOOTPRINT MEDICAL CLYDE BAKER
K091773 08/07/2009 FUJINON STERILE OVERTUBES FUJINON, INC. JOSEPH M AZARY
K091533 08/17/2009 SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 GARRISON DENTAL SOLUTIONS JOSEPH AZARY
K092004 08/25/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE HEALTHCARE ALAN TOTAH
K092027 08/28/2009 CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOEL C KENT
K092140 08/21/2009 GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. JAMES TURNER
K092079 08/06/2009 MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. JAMES T TURNER
K091062 08/04/2009 MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 GISH BIOMEDICAL, INC. JANET PEETS
K091782 08/13/2009 REVERE 6.35 STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K092108 08/13/2009 TRUSS THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K082723 08/31/2009 GRINDGUARD GRIND GUARD TECHNOLOGIES, LLC BILL MCLAIN
K080844 08/13/2009 G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE GYRUS ACMI, INC. LORRAINE CALZETTA
K090581 08/21/2009 TANTALUM BEAD SET, MODEL P003175 HALIFAX BIOMEDICAL, INC. ROSHANA AHMED
K092053 08/20/2009 MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH HANDPIECE HEADQUARTERS TIM ROPCHAN
K091338 08/26/2009 COLLASORB COLLAGEN WOUND DRESSING HARTMANN-CONCO INC. E.J. SMITH
K092357 08/25/2009 CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K090960 08/20/2009 VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, HOLLISTER, INC. CHRIS STUKEL
K092405 08/27/2009 MAMMOSITE MULTI LUMEN HOLOGIC, INC. JENNIFER SULLIVAN
K092307 08/25/2009 IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR IMASIGHT INC JEAN CASAULT
K091238 08/13/2009 UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K083728 08/12/2009 INVISION SYSTEM INNEROPTIC TECHNOLOGY, INC CAROLINE GREEN
K090727 08/13/2009 IMM DENTAL IRRIGATION TUBING SET INNOVATIVE MEDICAL MANUFACTURING CO. JOSEPH J CHANG
K091763 08/14/2009 MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 INSTRATEK, INC. JEFF SEAVEY
K091465 08/21/2009 MYOSURE ROD LENS HYSTEROSCOPE INTERLACE MEDICAL, INC. JOHN VOZELLA
K091902 08/21/2009 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 INVIVO ELIZABETH WHEELER
K091629 08/11/2009 PROTEUS 235 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A. YVES JONGEN
K092136 08/07/2009 PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 ISORAY MEDICAL, INC. FRED SWINDLER
K092458 08/28/2009 PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 ISORAY MEDICAL, INC. FRED SWINDLER
K091193 08/10/2009 ACCELL EVO3C ISOTIS ORTHOBIOLOGICS, INC CARROLL COUNCILMAN
K090818 08/18/2009 KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K091357 08/10/2009 MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 KIMBERLY-CLARK CORP. DAVID M LEE
K091039 08/07/2009 KOWA, FM-600, MODEL LSS50 KOWA CO. LTD. SATOHIKO TAKANASHI
K091098 08/07/2009 KOWAGENESIS-DF KOWA CO. LTD. AKIHIRO GUJITA
K090309 08/28/2009 LAGIS ENDOSCOPIC INSTRUMENTS LAGIS ENTERPRISES CO, LTD. JOSEPH J CHANG
K082947 08/14/2009 LENSX 550 LASER SYSTEM LENSX LASERS, INC. JUDY GORDON
K092291 08/21/2009 SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH ELAINE DUNCAN
K090456 08/26/2009 INSUFLOW LEXION MEDICAL, LLC. BERNARD HORWATH
K090343 08/11/2009 SENTINEL SPINAL SYSTEM LIFE SPINE MURALI AUDIPUDY
K090774 08/13/2009 LIGHTLAS SELECTOR LIGHTMED CORP. ANITA CHEN
K091682 08/20/2009 LSVT C OR LSVT COMPANION, MODEL V.1 LSVT GLOBAL, LLC DAVID H MCFARLAND
K091320 08/19/2009 SPECTRA SP II, SPECTRA DENTA II LUTRONIC CORPORATION MAUREEN O'CONNELL
K091733 08/28/2009 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 MAQUET CARDIOVASCULAR, LLC ARTIE KAUSHIK
K090662 08/10/2009 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP MASIMO CORPORATION MARGUERITE THOMLINSON
K090048 08/14/2009 ASFORA BULLET CAGE SYSTEM MEDICAL DESIGNS, LLC KRISTI VONDRA
K090869 08/27/2009 MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD MEDTRONIC PERFUSION SYSTEMS JESSICA SIXBERRY
K091365 08/06/2009 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOAFAMOR DANEK MELISA LANSKY
K090740 08/14/2009 MODIFICATION TO: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LILA JOE
K091165 08/07/2009 HORIZON XVU MENNEN MEDICAL LTD. IFAT OREN
K090710 08/20/2009 MERCURY CPAP MERCURY MEDICAL PAUL DRYDEN
K092343 08/07/2009 EN SNARE ENDOVASCULAR SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC. GLENN NORTON
K081268 08/10/2009 SONIC AIR MM1500 + (MID), MODEL 50400014 MICRO-MEGA SOCIETE ANONYME ISABELLE BOURG
K091288 08/14/2009 MEDI-6000 MEDICAL IMAGE DIGITIZER MICROTEK INTERNATIONAL, INC. HUI-CHEN KAI
K090337 08/13/2009 TROPAZONE LOTION MIDLOTHIAN LABORATORIES BRYCE HARVEY
K081360 08/17/2009 PATHFAST CK-MB-II, PATHFAST MYO-II MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K082977 08/20/2009 BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP MK BIO, INC JANE ZHANG
K090240 08/06/2009 MONTERIS MEDICAL UFO MONTERIS MEDICAL CRAIG COOMBS
K092207 08/04/2009 RESTORELLE POLYPROPYLENE MESH MPATHY MEDICAL DEVICES INC CAROLINE STRETTON
K092203 08/12/2009 OMNISURE URETHRAL SLING, MODEL OTK52 MPATHY MEDICAL DEVICES, LTD. CAROLINE STRETTON
K090377 08/28/2009 SINUS QUICK EB SYSTEM NEOBIOTECH CO., LTD. JUNG B BANG
K083603 08/06/2009 I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL NEURO KINETICS JOE ARGYROS
K090811 08/27/2009 INSPIRA HD, MODEL: NL1000 NEUROLOGICA CORPORATION DONALD D FICKETT
K092235 08/06/2009 BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K091279 08/12/2009 NIPRO DISPOSABLE SYRINGE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K092102 08/25/2009 NORDICBRAINEX SOFTWARE, VERSION 1.0 NORDICIMAGINGLAB AS CHANDANA GURUNG BHANDARI
K091398 08/26/2009 ARTHROSCOPE ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K092222 08/20/2009 THERMAPULSE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K091944 08/03/2009 MODIFICATION TO: DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC ADAM HERDER
K091600 08/25/2009 DIRECTVISION GUIDE SYSTEM PERCUVISION LLC ERROL O SINGH, M.D.
K091554 08/07/2009 PHARMAPAC PERSONAL LUBRICANT PHARMAPAC LLC TOM OTTO
K091230 08/12/2009 HDR PROSTATE TEMPLATE AND ACCESSORIES PHOTON TECHNOLOGIES CORPORATION JEFFREY A EDWARDS
K083087 08/07/2009 ECOCEL POLICHEM S.A. HARI NAGARADONA
K090781 08/13/2009 HELIO2 BLENDER PRECISION MEDICAL, INC. JAMES PARKER
K092500 08/20/2009 MODIFICATION TO PROFLU+ ASSAY PRODESSE, INC. KRISTINE SCHRAUFNAGEL
K091628 08/21/2009 OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX PROTEC GMBH & CO. KG JOCHEN KRUPP
K092232 08/19/2009 MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 PURICORE INC. DENNIS J MAHONEY
K083571 08/13/2009 ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR PURNABINA SDN BHD ROBERT HILL
K090762 08/28/2009 LEDA QUANTEL DERMA GMBH DIETMAR FISCHER
K083208 08/25/2009 SATURN ACTIVE LASER SYSTEM RESEARCH INSTRUMENTS LTD.
K091129 08/03/2009 QUATTRO LT RESMED LTD. DAVID D'CRUZ
K091319 08/03/2009 REMSTAR AUTO A-FLEX RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K092217 08/21/2009 MERCURY VCO2 RESPIRONICS NOVAMETRIX, INC. KEVIN MADER
K092043 08/05/2009 BIPAP SYNCHRONY 2 RESPIRONICS, INC. ZITA YURKO
K090750 08/05/2009 RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K082699 08/19/2009 ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS ROCHE DIAGNOSTICS JANE PHILLIPS
K091142 08/31/2009 TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 RTI BIOLOGICS, INC. TRAVIS AROLA
K083382 08/13/2009 CHROMA, MODEL: RZ153C SCOTTCARE CORPORATION TIMOTHY J LEYVA
K092323 08/19/2009 CONTURA CAVITY MAINTENANCE CATHETER SENORX, INC. EBEN GORDON
K091408 08/18/2009 DISPOSABLE PRESSURE TRANSDUCER SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD LEE FU
K091521 08/10/2009 POWERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG CENTURY PLASTIC CO., LTD CHU XIAOAN
K091167 08/06/2009 SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES SHINA CORP. YONG NAM SHIN
K092022 08/17/2009 TISSU TRANS HARVEST TUBING SHIPPERT MEDICAL TECHNOLOGIES CORP. SARAH L SHIPPERT
K092519 08/27/2009 SYNGO.X SIEMENS AG, MEDICAL SOLUTIONS SVEN KNOKE
K091123 08/14/2009 ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS CLARE SANTULLI
K091289 08/06/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS CLARE SANTULLI
K092073 08/07/2009 MONOPOLY PEDICLE SCREW SYSTEM SIGNUS MEDICAL THOMAS HOGHAUG
K083031 08/18/2009 PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT SMITHS MEDICAL ASD, INC. JOHN TULLETT
K090304 08/28/2009 WAVEON WRX BONE FIXATION SYSTEM SONOMA ORTHOPEDIC PRODUCTS, INC. CARLOS GONZALEZ
K090342 08/11/2009 POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 SOPHYSA SA ESTHER SALTZ
K092315 08/12/2009 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR SORIN GROUP ITALIA S.R.L. BARRY SAIL
K091410 08/11/2009 DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, SPES MEDICA S.R.L. ALFREDO SPADAVECCHIA
K092572 08/26/2009 CORE*IT DUAL SPIDENT CO., LTD. I.S. WHANG
DEN080011 08/07/2009 SNAP WOUND CARE DEVICE SPIRACUR, INC. JANICE M HOGAN
K081406 08/07/2009 SNAP WOUND CARE DEVICE SPIRACUR, INC. JANICE M HOGAN
K092310 08/27/2009 SEGUIN ANNULOPLASTY RING ST. JUDE MEDICAL THOMAS RADEMACHER
K092075 08/07/2009 CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI COLLEEN CANAN
K091158 08/10/2009 SCALAR WAVE LASER SYSTEM STELLAR LASERS KEVIN WALLS
K083097 08/03/2009 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION JOHN R SCOVILLE
K083643 08/07/2009 VERIFY 275F GRAVITY INDICATORS STERIS CORPORATION JOHN ROBERT SCOVILLE, JR.
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