FDA 510(k) Decisions During September, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K091632 09/03/2009 SPK SEALANT 3M COMPANY SHARI MYSZKA
K090718 09/21/2009 BELLUS SHADING KIT 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K091826 09/25/2009 ELEGANT 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K091825 09/25/2009 HI-TORQUE PROGRESS GUIDE WIRE FAMILY ABBOTT VASCULAR INC. MICHELE WALZ
K091999 09/18/2009 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K092594 09/16/2009 ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX ACE SURGICAL SUPPLY CO., INC. J.EDWARD CARCHIDI
K092393 09/01/2009 EK/P. AERUGINOSA PNA FISH ADVANDX, INC. PAULA E BULGER
K092143 09/22/2009 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K092635 09/10/2009 ALCATEL-LUCENT TELEHEATH MANAGER ALCATEL-LUCENT CANADA INC. ALEX GIOSA
K091544 09/09/2009 S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 ALFA WASSERMANN, INC. HYMAN KATZ
K091930 09/23/2009 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB ANCHOR PRODUCTS CO. GARY S THRUN
K091619 09/08/2009 ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) ANGLEFIX RICHARD JANSEN
K092327 09/21/2009 MICRO-TOUCH NITRA FREE ANSELL HEALTHCARE PRODUCTS LLC CYNTHIA A INGRAM
K091647 09/21/2009 INJECTAFIL APEX DENTAL MATERIALS, INC. CHRIS KULTON
K091228 09/28/2009 SPINEWAND SURGICAL DEVICE ARTHROCARE CORP. VALERIE DEFIESTA-NG
K091239 09/22/2009 ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB LINDA K SCHULZ
K091920 09/28/2009 ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL ASTRA TECH, INC. BETSY A BROWN
K091406 09/04/2009 ATLAS SPINE SPACER ATLAS SPINE LLC JEANNETTE DAILEY
K090117 09/29/2009 AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET AUTOSAFE-REFLEX INC. JOHN STEPHENS
K083868 09/25/2009 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 AXIS-SHIELD DIAGNOSTICS, LTD. Claire Dora
K091321 09/11/2009 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC. HOWARD J SCHRAYER
K091718 09/02/2009 NEUTRASAL BARTOR PHARMACAL CO., INC. EDWARD D KOBUS
K092533 09/15/2009 FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF JOY VOIGT
K090339 09/23/2009 BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 BELIMED SAUTER AG CHRIS P MANNARINO
K083744 09/01/2009 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 BINAX, INC. Anne Jepson
K091489 09/04/2009 CLEARVIEW ADVANCED STREP A , MODEL 737-430 BINAX, INC. ERIN E KENALEY
K083536 09/11/2009 DENSICHEK PLUS BIOMERIEUX, INC. JOLYN TENLLADO
K091608 09/17/2009 COBALT MV BONE CEMENT BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K090757 09/25/2009 BIOMET MODULAR FEMORAL REVISION SYSTEM BIOMET, INC. BECKY EARL
K090898 09/04/2009 CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER BIOSENSE WEBSTER, INC. NATALIE BENNINGTON
K092624 09/25/2009 FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K082841 09/09/2009 SPINAL FORAMINOSCOPE BLAZEJEWSKI MEDI-TECH GMBH ANGELIKA SCHERP
K090871 09/04/2009 CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 BONESUPPORT AB ANN-CHRISTINE PROVOOST
K083715 09/15/2009 BELTBEAT WF-400 BONUS COMMUNICACIONES SRL BENNY ARAZY
K090175 09/10/2009 UNITY BETA PLLA SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K091135 09/14/2009 RUTTER SUPRA STOMAL STENTS BOSTON MEDICAL PRODUCTS, INC. MICHAEL A WARREN
K092666 09/30/2009 INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K092455 09/04/2009 MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation SHANNON PETIT
K091841 09/02/2009 BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 BRIDGEPOINT MEDICAL JILL MUNSINGER
K090496 09/01/2009 QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH CARDIAC LEAD TECHNOLOGIES, INC. CLAUDIA LEWIS-ENG
K091943 09/10/2009 POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K092304 09/15/2009 ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K082118 09/18/2009 XPERT HEMOSIL FACTOR II & FACTOR V ASSAY CEPHEID RUSSEL K ENNS
K091559 09/18/2009 MARKSMANN CATHETER CHESTNUT MEDICAL TECHNOLOGIES, INC. DANIEL CHER
K091877 09/02/2009 CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K083567 09/14/2009 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW CO-LIGNE AG DAVID W SCHLERF
K083783 09/11/2009 VF LIQUIGEL COAPT SYSTEMS, INC. LOUIS-PIERRE MARCOUX
K091921 09/08/2009 CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP Codman & Shurtleff, Inc. PAUL AMARAL
K090216 09/18/2009 COLLAGEN DENTAL MEMBRANE IV COLLAGEN MATRIX, INC. PEGGY HANSEN
K092132 09/24/2009 XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K090193 09/25/2009 CONDUCTOR CORONARY GUIDEWIRE CONCERT MEDICAL, LLC PAMELA PAPINEAU
K092441 09/09/2009 MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH
K090773 09/18/2009 CFI ULTRASOUND PROBE DRAPE CONTOUR FABRICATORS, INC. JOHN W SCHAEFER
K090254 09/04/2009 SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. PATRICIA KEARINS
K090183 09/25/2009 HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON COOK ENDOSCOPY TIFFANNY THOMAS
K082939 09/03/2009 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 COOK UROLOGICAL, INC. CINDY FOOTE
K091637 09/29/2009 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K091223 09/11/2009 VALLEYLAB SUCTION COAGULATOR, MODEL E3305 COVIDIEN LP PHILIP AKE
K091869 09/01/2009 SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K091800 09/23/2009 LIPOEZE LASER ASSISTED ASPIRATION CANNULA CURVE MEDICAL F. DAVID ROTHKOPF
K091537 09/03/2009 CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH CYNOSURE, INC. ANTHONY BURNS
K092319 09/16/2009 STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 DANVILLE MATERIALS, INC. CRAIG BRUNS
K090911 09/11/2009 IST SNORING APPLIANCE DENTAL CRAFTERS AMY NYSTROM
K092626 09/25/2009 MODIFICATION TO: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K091171 09/11/2009 D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K090104 09/09/2009 LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DIASORIN, INC. KELLY R SAUER
K092130 09/21/2009 RASCAL WE GO 250 POWERED WHEELCHAIR ELECTRIC MOBILITY CORP. W. STEPHEN BEVERSLUIS
K092083 09/22/2009 EXTEND FRAME SYSTEM, MODEL 1009633 ELEKTA INSTRUMENT AB ABDERS SKOGLUND
K091350 09/15/2009 ESTECH HAWKEYE INTRODUCER SYSTEMS ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K090855 09/18/2009 EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE ETEX CORP. CHRISTOPHER KLACZYK
K091211 09/04/2009 EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS ETHICON ENDO-SUGERY, LLC ASIFA VONHOF
K092577 09/15/2009 ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) ETHICON ENDO-SURGERY, LLC Abhilasha Mukherjee
K092495 09/22/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 EV3 NEUROVASCULAR LAURIE E CARTWRIGHT
K092562 09/18/2009 MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS FHC, INC. LEE D MARGOLIN
K083428 09/01/2009 F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY FIAB SPA SILVIA CALABRO
K081996 09/15/2009 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN
K092629 09/25/2009 SNM FIRMGRIP FLEXICATH LTD. TALI HAZAN
K091488 09/14/2009 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C FOOTPRINT MEDICAL CLYDE BAKER
K091214 09/25/2009 FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER FOOTPRINT MEDICAL CLYDE BAKER
K091213 09/25/2009 FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN FOOTPRINT MEDICAL CLYDE BAKER
K092645 09/05/2009 FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 FUJIREBIO DIAGNOSTICS, INC. JOHN GORMLEY
K092189 09/18/2009 POGO SCREW FXDEVICES RICH LIPSCHUTZ
K092020 09/29/2009 AADVA ZR COLORING LIQUID GC AMERICA INC. MARK HEISS
K092680 09/23/2009 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN GE HEALTHCARE FINLAND OY RAUNO RUOHO
K092756 09/28/2009 GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM GE VINGMED ULTRASOUND AS JAN T THOLLEFSEN
K092576 09/04/2009 GEM HEART ONE/ONE+ GEM-MED S.L. WILSON TSENG
K092633 09/25/2009 OSOM INFLUENZA A&B TEST , MODEL PN190 GENZYME CORPORATION FIL BUENVIAJE
K090449 09/18/2009 MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT GISH BIOMEDICAL, INC. JANET PEETS
K090450 09/18/2009 MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT GISH BIOMEDICAL, INC. JANET PEETS
K090557 09/28/2009 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM GIVEN IMAGING LTD. Tim Thomas
K092851 09/29/2009 MODEL GDCH-2000 GLOBAL DENTAL DIRECT, INC. DON TEMPLE
K092610 09/24/2009 MODIFICATION TO BEACON STABILIZATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K092373 09/03/2009 ICS CHARTR EP 200 GN OTOMETRICS DANIEL KAMM
K091359 09/02/2009 GSO PCT SPINAL SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K091187 09/14/2009 GRACE DYNAMIC TORP Grace Medical, Inc. JEFF COBB
K092200 09/16/2009 POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) GX CORPORATION SDN BHD FOO KHON PU
K092278 09/29/2009 GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K083157 09/29/2009 HS AMICA H.S HOSPITAL SERVICE S.P.A. LUCIO IMPROTA
K091808 09/10/2009 SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 HANSEN MEDICAL, INC. KATE WHITIN
K091652 09/04/2009 NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K092161 09/30/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF HEALTH & LIFE CO., LTD. SARAH SU
K091220 09/21/2009 HEALTHANYWHERE SYSTEM HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY SHAWN SLADE
K092155 09/21/2009 HEARTWAY POWER MOBILITY SCOOTER, S8 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K092154 09/21/2009 HEARTWAY POWER MOBILITY SCOOTER, S9 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K091635 09/03/2009 VENUS DIAMOND FLOW HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K090652 09/25/2009 ALPHA DUO LAP INSUFFLATOR HIPPOKRATEC GMBH CHRISTIAN SIEDERSBERGER
K091268 09/18/2009 HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS HOSPIRA, INC. DANIELA WEKSLER
K092419 09/01/2009 AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092671 09/23/2009 VARIAX ELBOW SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092018 09/18/2009 OMNIPRO INCLINE IBA DOSIMETRY GMBH CHUCK LINDLEY
K091166 09/02/2009 IMRX IMRIS, INC. THOMAS M TSAKERIS
K083378 09/29/2009 SYNERGY INNERSPACE, INC. DON BOBO
K083288 09/03/2009 DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER INNOVA VISION INC. JENNIFER REICH
K092715 09/28/2009 IROOT BP PLUS INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K091980 09/22/2009 ACL TOP 700 LAS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K092430 09/04/2009 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K092413 09/04/2009 INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K091117 09/15/2009 ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA ISOAID, L.L.C. BENJAMIN ROEDELL
K083559 09/04/2009 YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. NORMAN F ESTRIN
K091968 09/14/2009 KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K090863 09/21/2009 PERSONAL WHEEZOMETER KARMELSONIX YORAM LEVY
K091685 09/03/2009 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 KIMBERLY-CLARK CORP. LISA PEACOCK
K091562 09/08/2009 DOCTOR SMILE A-810 AND B-980 LASERS LAMBDA SCIENTIFIC SPA BOSCHI ALESSANDRO
K091818 09/23/2009 LAURIMED SPINAL INJECTION SYSTEM LAURIMED LLC SEVRINA CIUCCI
K091366 09/03/2009 INSUFLOW DEWHEART LEXION MEDICAL, LLC. BERNARD HORWATH
K091981 09/28/2009 LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER LIGHTMED CORP. ANITA CHEN
K091534 09/18/2009 LIGHTLAS MODEL 532 LIGHTMED CORP. ANITA CHEN
K091962 09/30/2009 POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 LUMENIS, INC. MIKE AYMAMI
K083846 09/01/2009 XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K091998 09/28/2009 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP MAKO SURGICAL CORP. WILLIAM TAPIA
K091280 09/25/2009 FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT MAXX ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K092038 09/23/2009 APTUS K-WIRE SYSTEM MEDARTIS AG KEVIN THOMAS
K092653 09/18/2009 VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 MEDCOM GMBH STEFAN WALTER
K091953 09/16/2009 PRO-PICC MEDCOMP JEAN CALLOW
K092347 09/16/2009 PRO-PICC CT MEDCOMP JEAN CALLOW
K090394 09/01/2009 VALVED TEARWAY INTRODUCER MEDCOMP JEAN CALLOW
K091991 09/04/2009 EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 MEDICA CORP. Photios Makris
K092506 09/16/2009 EASYRA GLU-H REAGENT, MODEL 10200 MEDICA CORP. Photios Makris
K092284 09/01/2009 LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 MEDICAL DEVICE RESOURCE CORP. MELBOURNE KIMSEY
K091202 09/16/2009 WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, MEDSHAPE SOLUTIONS JACK GRIFFIS
K091312 09/02/2009 PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY JEFFERY HENDERSON
K090353 09/29/2009 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK LEE GRANT
K091974 09/02/2009 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K091883 09/21/2009 T2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. THERESA LEISTER
K091798 09/02/2009 MERETE COMPRESSION SCREWS MERETE MEDICAL GMBH JORG MIETZNER
K092553 09/11/2009 TRU FLU, MODEL 751230 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K090810 09/18/2009 THERMO SCIENTIFIC CYTO-CAL COUNT TUBES MICROGENICS CORP. LISA CHARTER
K092051 09/21/2009 THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 MICROGENICS CORP. LISA CHARTER
K091887 09/18/2009 LED CURING LIGHT, MODEL GT-1500 MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K083840 09/28/2009 MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH CHRISTINE STROBEL
K091218 09/28/2009 DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ JOY
K092003 09/30/2009 CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE MyCardio, LLC ROBERT SCHUEPPERT
K091155 09/03/2009 ASCEND NEUROMETRIX, INC. RAINER MAAS
K092742 09/22/2009 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANGFANG
K092237 09/09/2009 NSM-S15 SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K090932 09/24/2009 NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 NEXGEN MEDICAL SYSTEMS, INC. JOHN KUCHARCZYK
K091553 09/21/2009 BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE NINGBO DIAIER ELECTRONIC CO., LTD. LAO XIKUN
K091756 09/22/2009 NOBELPROCERA TI ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K091904 09/25/2009 NOBELPROCERA ZI ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K091853 09/21/2009 WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 NSPIRE HEALTH, INC. KIMBERLY STARK
K091937 09/09/2009 OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM OBP CORPORATION KEITH ISAACSON
K090174 09/14/2009 TSI; ERI OCO BIOMEDICAL JACK BLOOM
K091495 09/03/2009 SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO
K091759 09/18/2009 SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K091676 09/01/2009 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 OMRON HEALTHCARE, INC. PAUL DRYDEN
K091411 09/25/2009 KNEEALIGN SYSTEM ORTHALIGN, INC AMY WALTERS
K091861 09/03/2009 VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K091614 09/10/2009 OSTEOMED FOOT PLATING SYSTEM OSTEOMED L.P. ALMA RELJA
K091093 09/30/2009 PARCUS PPEK CF INTERFERENCE SCREW PARCUS MEDICAL, LLC BARTON BRACY
K091094 09/30/2009 PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 PARCUS MEDICAL, LLC BARTON BRACY
K092332 09/03/2009 JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K090752 09/21/2009 PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 PENUMBRA, INC. LOUISE MUSANTE
K090846 09/03/2009 GSP INSTRUMENT AND GSP NEONATAL HTSH KIT PERKINELMER, INC. KAY A TAYLOR
K091572 09/22/2009 DISPOSABLE SPO2 SENSOR M1134A PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN JENS-PETER SEHER
K082391 09/01/2009 PRIMAEVA MEDICAL RENESIS SYSTEM PRIMAEVA MEDICAL, INC. BRIAN GRIGSBY
K092012 09/25/2009 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 PRIMED MEDICAL PRODUCTS INC. RAYMOND MARUSYK
K091964 09/24/2009 CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS PROCTER & GAMBLE CO. VICTORIA P SCHOFIELD
K092698 09/15/2009 QUICKVUE INFLUENZA A+B TEST QUIDEL CORP. JOHN D TAMERIUS
K091852 09/10/2009 BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 REFRACTRON TECHNOLOGIES CORP. JOHN GAGLIARDI
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