FDA 510(k) Decisions During September, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101885 09/09/2010 MEDTRONIC C315 DELIVERY CATHETER MEDTRONIC INC. BRUCE BACKLUND
K101834 09/03/2010 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM 3M COMPANY JIZHONG JIN
K101249 09/08/2010 STERIGAGE MODEL 1243RA, 1243RB, 1243RE 3M COMPANY SUZANNE LEUNG
K100718 09/03/2010 AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K093254 09/15/2010 AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION ABBOTT MEDICAL OPTICS INC KESLEY E GALLAGHER
K101170 09/17/2010 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM ACUTE INNOVATIONS LLC MARIAH KNIGHT
K101555 09/17/2010 CO2 LASER SYSTEM ADVANCED TECHNOLOGY LASER CO., LTD. DIANA HONG
K100037 09/23/2010 ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD ADVANCED VERTEBRAL SOLUTIONS, LLC MIKE DUGERY
K101034 09/02/2010 NIOX MINO MODEL 09-1000 AEROCRINE AB JOHANNA KARLING
K100243 09/02/2010 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC LISA BOYLE
K102716 09/28/2010 MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS ALMA LASERS, INC. TATIANA EPSTEIN
K101958 09/29/2010 AMSINO I.V. ADMINISTRATION AND EXTENSION SETS AMSINO INTERNATIONAL, INC. JESUS FARINAS
K101824 09/13/2010 AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER AMSINO INTERNATIONAL, INC. JESUS FARINAS
K102353 09/17/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 ANDON HEALTH CO.,LTD LIU YI
K102356 09/20/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 ANDON HEALTH CO.,LTD LIU YI
K100221 09/14/2010 INTELLIWAVE3 ART OPTICAL CONTACT LENS, INC. MARTIN DALSING
K100479 09/21/2010 PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE ARTHROCARE CORP. VALERIE DEFIESTA-NG
K100578 09/22/2010 ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S ASAHI INTECC CO., LTD. YOSHI TERAI
K101568 09/20/2010 MODEL SB100II FINGER PULSE OXIMETER ATLANTEAN PAUL DRYDEN
K100727 09/14/2010 LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK BIO-RAD, DIAGNOSTICS GRP. SUZANNE PARSONS
K100985 09/09/2010 BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K100726 09/15/2010 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM BIOLITEC, INC. HARRY HAYES
K102107 09/03/2010 OSSTAPLE CHILL BIOMEDICAL ENT., INC. JOE W SOWARD
K101566 09/28/2010 VITEK 2 YEAST CASPOFUNGIN BIOMERIEUX, INC. NANCY WEAVER
K100114 09/29/2010 FAT CONCENTRATION SYSTEM BIOMET, INC. LONNIE WITHAM
K101086 09/03/2010 TAPERLOC COMPLETE BIOMET, INC. GARY BAKER
K101064 09/14/2010 BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P BREDENT GMBH & CO.KG ANDREA PECSI
K102211 09/03/2010 CRUISER 18 GUIDEWIRE BRIVANT, LTD. TOMAS FUREY
K101537 09/30/2010 AIM 200, MAJOR SURGICAL LIGHT BURTON MEDICAL PRODUCTS CORP. SCOT KINGHORN
K101097 09/22/2010 CALGAESEAL MODEL: CAS BZ MEDICAL INC BYRON ZAHLER
K101825 09/29/2010 CRYOBALLOON ABLATION SYSTEM C2 THERAPEUTICS PETER GARCIA-MEZA
K093367 09/10/2010 STERILE SALINE SOLUTION CACHET PHARMACEUTICALS PVT. LTD. SHIVKUMAR AGRAWAL
K102373 09/30/2010 CALYPSO SYSTEM WITH DYNAMIC EDGE GATING CALYPSO MEDICAL TECHNOLOGIES INC ED VERTATSCHITSCH
K101814 09/27/2010 DIRECT CROWN NATURAL 1 CANDULOR USA, INC. DONNA MARIE HARTNETT
K100540 09/23/2010 ASCENT F-COAT MODEL: 006-00097 CAO GROUP, INC. ROBERT LARSEN
K094062 09/27/2010 PERCU-PRO GUIDEWIRE CARDIOSOLUTIONS INC MICHELE LUCEY
K101661 09/16/2010 MYRAY HYPERION CEFLA DENTAL GROUP CYNTHIA J NOLTE, PH.D.
K101301 09/24/2010 STALIF MIDLINE CENTINEL SPINE JUSTIN EGGLETON
K101429 09/15/2010 ECO SUPERGEL CERACARTA SPA ELAINE DUNCAN
K101366 09/17/2010 I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) CHROMOGENEX TECHNOLOGIES LTD PETER R BEVAN
K101589 09/20/2010 BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K102303 09/10/2010 BLOOD PRESSURE METER, MODEL CH-658 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K101567 09/02/2010 SHARPS CONTAINER CIXI LEINUO PLASTIC CO. LTD CHARLES MACK
K094050 09/16/2010 ITOTAL CR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K102291 09/15/2010 COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN TIM M LOHNES
K100418 09/03/2010 SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE COVIDIEN WING NG
K101983 09/21/2010 CRITICAL CARE ASSESSMENT CRITICAL PATIENT CARE, INC. MARIE COSGROVE
K101602 09/01/2010 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K101587 09/16/2010 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. BRYAN BROSSEAU
K101601 09/23/2010 AFFIRM DO DIODE LASER CYNOSURE, INC. ANTHONY BURNS
K101611 09/29/2010 RELAY POWER WHEELCHAIR DALTON INSTRUMENT CORP. JENNIFER YU
K101551 09/09/2010 PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. LEON LU
K094049 09/10/2010 STLASE DIODE LASER DENTAL PHOTONICS, INC MARCY MOORE
K100391 09/29/2010 DEPUY UNIVERSAL GRIPTION TF CONES DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR, MA
K101710 09/28/2010 LUXATEMP ULTRA /STAR DMG USA, INC. PAMELA PAPINEAU
K092977 09/29/2010 EBERLE SHAVER SYSTEM ACCESSORIES EFS EBERLE FEINWERKTECHNISCHE SYSTEME GERALD GOIGITZER
K102368 09/07/2010 NON-ABLATIVE WRINKLE TREATMENT HANDPIECE ELLMAN INT'L INC. JONATHAN ACHENBACH
K093723 09/08/2010 EMS MINIMASTER LED EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J.M. NOLTE
K091956 09/28/2010 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 ENCORE MEDICAL, L.P. ELIZABETH ONDERLINDE
K093901 09/10/2010 SURGICAL FACE MASK EPARD PROTECTIVE PRODUCTS, LTD DARREN REEVES
K092734 09/20/2010 E-LIGHT LINE ESPANSIONE MARKETING S.P.A GUIDO BONAPACE
K091969 09/02/2010 EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K092736 09/02/2010 EUROIMMUN ANTI-M2-3E ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K100017 09/13/2010 EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM EUROIMMUN US INC KATHRYN KOHL
K101689 09/20/2010 EMM EQUIPMENT COVER-POLYTHYLENE EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101688 09/20/2010 EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101593 09/03/2010 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K093430 09/02/2010 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. EXACTECH, INC. GRAHAM CUTHBERT
K101761 09/21/2010 EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 EXACTECH, INC. DARRELL KASSNER
K102260 09/24/2010 FDI GLUCOSE CONTROL SOLUTIONS FUJIREBIO DIAGNOSTICS, INC KENT PRUETT
K101420 09/17/2010 GC FUJI TEMP GC AMERICA, INC. MARK HEISS
K093694 09/20/2010 GERATHERM UNIQUERESC GERATHERM MEDICAL AG ANDREA PECSI
K101200 09/30/2010 PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE GIVEN IMAGING LTD. TIM THOMAS
K101477 09/28/2010 BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) WENDY MCMANUS
K101694 09/08/2010 HANDHELD PULSE OXIMETER MODEL M800 GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K102040 09/24/2010 PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. ANA HONG
K100971 09/27/2010 ATEK SURGICAL GOWNS HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD GLEN FEYE
K093834 09/29/2010 CRIT-LINE ANEMIA MANAGEMENT SOFTWARE HEMA METRICS, LLC TERRY LANIER
K101617 09/07/2010 FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K094003 09/17/2010 REVIVATOR HERSILL, S.L. ANA MARIA ROMERO
K102098 09/27/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES HONG DI PLASTIC PRODUCTS CO, LTD. JIE LIU
K101435 09/15/2010 IMIX PANORAD AND SOMARAD IMIX ADR FINLAND OY DANIEL KAMM, P.E.
K100992 09/24/2010 NEURALMAS INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") SUSAN D GOLDSTEIN-FALK
K102266 09/24/2010 ISOLED AC-POWERED LED HEADLIGHT SYSTEM ISOLUX LLC NIKOLAUS ANDREOULAKIS
K101373 09/15/2010 EMBRACE IZI MEDICAL PRODUCTS INC. HELEN SHAFER
K093137 09/28/2010 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL KAMIYA BIOMEDICAL CO. SHAWN KAPLAN
K100657 09/17/2010 V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM ("V.A.C. ULTA THERAPY SYSTEM") MODEL V.A.C. ULTA THERAPY UNIT MODEL U KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K100899 09/13/2010 OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. RON WARREN
K102032 09/08/2010 KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12" STERILE PAIRS KIMBERLY-CLARK CORP. LESTER F PADILLA
K100793 09/22/2010 UROSTATION 3D PROSTATE SUITE KOELIS CECILE DESMULIE
K102442 09/10/2010 E.S.O. (ELECTRO SENSOR OXI) L.D. TECHNOLOGY, LLC ALBERT MAAREK
K102036 09/28/2010 DOCTOR SURGERY DIODE LASERS FAMILY LAMBDA S.P.A. BOSCHI ALESSANDRO
K102265 09/29/2010 LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM LDR SPINE USA BECKINAM NOWATZKE
K101740 09/20/2010 ALBOSURE POLYESTER VASCULAR PATCH LEMAITRE VASCULAR, INC. VIC ZHANG
K102136 09/27/2010 VESSEL GUARDIAN LEXION MEDICAL, LLC. BERNARD HORWATH
K101573 09/23/2010 ACCUSCULPT II LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K101771 09/20/2010 RELINE-IT MODEL RELINE-IT MAJESTIC DRUG CO., INC. ROGER S MASTRONY
K101157 09/17/2010 E-BASIC SINGLE BREAST PUMP MAPA GMBH SHEILA W PICKERING
K101426 09/15/2010 CEROS TCP GRANULES MATHYS LTD LINDA SCHULZ
K102437 09/24/2010 GMK REVISION KNEE SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K101791 09/23/2010 ROSA SURGICAL DEVICE MEDTECH SAS BERTIN NAHUM
K102176 09/01/2010 FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 MEDTRONIC CRYOCATH LP KARI LAHTI
K101186 09/03/2010 AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG MEDTRONIC PERFUSION SYSTEMS CARALEE WALTON
K091445 09/27/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K101772 09/30/2010 TSRH(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LILA JOE
K102273 09/07/2010 MERIT BIPOLAR COAGULATION PROBE MERIT MEDICAL SYSTEMS, INC. DAN W LINDSAY
K102178 09/02/2010 EASY TOUCH MHC MEDICAL PRODUCTS DANIEL KAMM
K102004 09/10/2010 ENDEAVOUR MONITORING SYSTEM MINDRAY DS USA, INC. RUSSELL OLSEN
K102173 09/13/2010 MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 MOLDEX/METRIC, INC. MARK MEINECKE
K100029 09/15/2010 MEPILEX BORDER AG DRESSING MOLNLYCKE HEALTH CARE STEVEN DOWDLEY
K102021 09/17/2010 CRYO-TOUCH II MYOSCIENCE INC TRACEY HENRY
K101326 09/02/2010 NMI IC NAVILYST MEDICAL, INC. NICHOLAS CONDAKES
K101729 09/23/2010 NEOWIRE PTA/PTCA GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K101783 09/13/2010 COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE NEW STAR LASERS, INC. NATALIE R VOLLRATH
K101803 09/08/2010 NEWPORT E360 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K091952 09/10/2010 ACTA VESSEL OCCLUSION SYSTEM (VOS) NFOCUS NEUROMEDICAL, INC. BOB O'HOLLA
K101380 09/13/2010 RXPEAKFLOW NOBLE MARKETING LAURA LYONS
K101860 09/01/2010 NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GALSSER
K101976 09/14/2010 INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K101994 09/28/2010 APEX KNEE MODULAR TIBIA SYSTEM OMNLIFE SCIENCE RADHIKA TAUNTON
K102492 09/30/2010 P200MAAF OPTOS PLC HOWARD M HOLSTEIN
K101505 09/15/2010 RTVUE MODEL RTVUE 100 OPTOVUE, INC. JOHN TALARICO
K101676 09/13/2010 CLEARARCH ORMCO CORP. WENDY GARMAN
K101812 09/27/2010 CONSTRUX MINI PEEK SPACER SYSTEM ORTHOFIX INC. RUSSELL JOHNSON
K102156 09/30/2010 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K101962 09/27/2010 MINI MAXLOCK EXTREME PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K091618 09/27/2010 VITOMATRIX ORTHOVITA, INC. DEBORAH L JACKSON
K102438 09/30/2010 PRIMALOK FACET FIXATION SYSTEM OSTEOMED L.P. KAREN E WARDEN
K101524 09/29/2010 C2000 POWERED WHEELCHAIR OTTO BOCK HEALTH CARE, LP WILLIAM KABITZ
K101506 09/01/2010 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE
K101532 09/01/2010 NESSI OTC SPACER PHARMACARIBE PAUL DRYDEN
K102495 09/30/2010 M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 PHILIPS MEDICAL SYSTEMS THERESA POOLE
K101311 09/30/2010 EP NAVIGATOR R3 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K100550 09/28/2010 POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC POLYMEDCO, INC. HELEN LANDICHO
K101630 09/07/2010 POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE PT. SMART GLOVE INDONESIA CHO SOW FONG
K101918 09/24/2010 QUICKVUE RSV 10 QUIDEL CORP. JENNIFER S HANKARD
K102118 09/08/2010 SNORE GUARD ADVANCE RANIR LLC GERARD J PRUD'HOMME
K101130 09/02/2010 BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK RESPIRONICS, INC. ZITA A YURKO
K101129 09/16/2010 ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK RESPIRONICS, INC. ZITA A YURKO
K102267 09/10/2010 ELECSYS FERRITIN CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
K102016 09/01/2010 PRECICONTROL CLINCHEM MULTI 1 AND 2 ROCHE DIAGNOSTICS PATRICK J STIMART
K101456 09/08/2010 ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM ROCHE DIAGNOSTICS SUSAN HOLLANDBECK
K101203 09/10/2010 TINA-QUANT ALBUMIN GEN 2 ROCHE DIAGNOSTICS KATHIE J GOODWIN
K100853 09/09/2010 COBAS 8000 MODULAR SERIES ANALYZER ROCHE DIAGNOSTICS CORP. ANGELO PEREIRA
K101054 09/03/2010 ROMIAPEX MODEL A-15 ROMIDAN LTD EITAN MARGALIT
K101496 09/14/2010 CABLECAP MODEL: WLF, STZ, ACM SENSORMED WILLIAM MILAM
K093883 09/20/2010 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- SEPPIM S.A.S. DEBRA K HUTSON
K101646 09/08/2010 NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR SGMP CO., LTD. JANNA P TUCKER
K101039 09/20/2010 SHIMADZU COLLIMATOR R-300 SHIMADZU CORP. DON KARLE
K093107 09/30/2010 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS CLARE SANTULLI
K101425 09/10/2010 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES SIEMENS HEALTHCARE DIAGNOSTICS ELISABETH WARRINER
K101550 09/03/2010 BIOGRAPH MCT FAMILY SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K102017 09/20/2010 SC2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K101869 09/29/2010 PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) SILMET LTD. SHARON CHAPLIK
K091467 09/17/2010 BABY QUASAR SILVER BAY, LLC DANIEL KAMM, P.E.
K092551 09/14/2010 SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW INC., ENDOSCOPY DIV. CHRISTINA FLORES
K100795 09/02/2010 JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING SMITH & NEPHEW, INC. SHEREEN MYERS
K100787 09/17/2010 RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT SMITH & NEPHEW, INC. LAURA D REYNOLDS
K093047 09/27/2010 SMITH & NEPHEW CIRCULAR FIXATION SYSTEM SMITH & NEPHEW, INC. SHEREEN MYERS
K100736 09/10/2010 KIRSCHNER AND GUIDE WIRES SMT SCHILLING METALLTECHNIK GMBH ANDRE WEINGERL
K102219 09/24/2010 SOCORRO SMI TUNNEL RELEASE DEVICE SOCORRO MEDICAL, INC. ED DIAO
K100112 09/28/2010 SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) SONOMA ORTHOPEDIC PRODUCTS, INC. CARLOS GONZALEZ
K101337 09/30/2010 A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM SONOSCAPE COMPANY LIMITED DIANA HONG
K102090 09/30/2010 SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM SPINE SMITH PARTNERS L.P. LAURA LEBOEUF
K101288 09/10/2010 STAXX XD SYSTEM SPINE WAVE, INC. ROAIDA RIZKALLAH
K102020 09/01/2010 VEGA SPAN SPINOUS PROCESS PLATE SYSTEM SPINEFRONTIER, INC. JOHN SULLIVAN
K101883 09/07/2010 6F ENGAGE/ENGAGE TR INTRODUCER ST. JUDE MEDICAL VENKATA DAMARAJU
K101697 09/22/2010 ENSITE VERISMO SEGMENTATION TOOL V.2.0 ST. JUDE MEDICAL KRIS MILLER
K101968 09/15/2010 SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A ST. JUDE MEDICAL SUSAN ENGELSON
K102462 09/21/2010 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS CORPORATION ROBERT SULLIVAN
K100442 09/07/2010 FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM SURGICAL INNOVATIONS GROUP PLC MIKE WHITE
K101536 09/15/2010 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM SYNTHES (USA) LLC LISA GRANEY
K102018 09/23/2010 NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY SYNTHES USA PRODUCTS LLC JEFFREY L DOW
K100421 09/27/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN YONKSHUN GLOVE, CO., LTD CHU XIAOAN
K102230 09/10/2010 NUGARD NITILE GREY COLOR TERANG NUSA SDN BHD ROBERT HILL
K100455 09/03/2010 SPAPLUS ANALYZER THE BINDING SITE JAY GELLER
K101310 09/02/2010 VU APOD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC GLENN STIEGMAN
K101490 09/08/2010 FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US THERMAGE, INC. KRISS FOSS
K101015 09/23/2010 GUIDE CATHETERS AND ACCESSORIES THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K101868 09/07/2010 INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K093960 09/14/2010 ST AIA-PACK CYSTATIN C, MODEL 025217 TOSOH BIOSCIENCE, INC. JUDITH K OGDEN
K092794 09/13/2010 TRANSCORP ACIF SYSTEM TRANSCORP, INC. ANDREW RODENHOUSE
K101375 09/15/2010 TRIMED X-FIX TRIMED, INC. KELLI ANDERSON
K101906 09/17/2010 SHAPE TO FIT COMPRESSION WEAR TSUNG HAU TECHNOLOGY CO., LTD. PEGGY KUO
K102430 09/10/2010 TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET TYCO ELECTRONICS CORPORATION DENNIS M GILKEY
K101245 09/17/2010 ULTRASEAL ID ULTRADENT PRODUCTS, INC. DIANE ROGERS
K102011 09/03/2010 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K091125 09/03/2010 CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 VERILUX RYAN DOUGLAS
K101734 09/08/2010 VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES VISIONSCOPE TECHNOLOGIES, LLC LIM CHEUNG PH.D
K101799 09/03/2010 POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE WEAR SAFE (MALAYSIA) SDN. BHD. MOHD AZLAN
K100969 09/20/2010 WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N WMI ENTERPRISES LLC MIKE WILFORD
K101977 09/14/2010 TAPERED SCREW-VENT T IMPLANT ZIMMER DENTAL INC. JEREMY MARKOVICH
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