FDA 510(k) Applications Received During August, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K102377 08/20/2010 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 08/09/2010 A-DEC 200 DENTAL SYSTEM A-DEC, INC. THOMAS H LOUISELL
K102240 08/09/2010 NIVO NEBULIZER SYSTEM AEROGEN IRELAND, LTD. CAITRIONA CONNEELY
K102424 08/25/2010 PREVISION HIP SYSTEM WITH RECON RING AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K102304 08/16/2010 BREEZE C MODEL C (3W), BREEZE C (4W) AFIKIM ELECTRIC VEHICLES AVNER FISHBEIN
K102338 08/23/2010 BREATHSCN PRO AKERS BIOSCIENCES, INC. BARBARA A BAGBY
K102402 08/24/2010 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K102359 08/19/2010 PICASSO/ PICASSO LITE/ PICASSO PERIO AMD LASERS, LLC AMY SZENTES
K102353 08/19/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 ANDON HEALTH CO.,LTD LIU YI
K102356 08/19/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 ANDON HEALTH CO.,LTD LIU YI
K102329 08/17/2010 NANOKNIFE SYSTEM ANGIODYNAMICS, INC. KIT CARIQUITAN
K102241 08/09/2010 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT ANTHOGYR SAS BRAYETTE SABINE
K102481 08/30/2010 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP APEX BIOTECHNOLOGY CORP. LISA LIU
K102333 08/17/2010 APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE APTUS ENDOSYSTEMS, INC. BURT GOODSON
K102262 08/10/2010 ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL ARTHROCARE CORP. VALERIE DEFIESTA-NG
K102226 08/09/2010 DUAL INCU I ATOM MEDICAL CORPORATION TSUYOSHI SUGINO
K102279 08/11/2010 INCU I ATOM MEDICAL CORPORATION TSUYOSHI SUGINO
K102227 08/09/2010 INFA WARMER I ATOM MEDICAL CORPORATION TSUYOSHI SUGINO
K102194 08/04/2010 SOLCART B B. BRAUN AVITUM AG ANGELA CARAVELLA
K102146 08/04/2010 BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. ISMAIL KILIC
K102192 08/04/2010 INDISCAL DIGITAL MANOMETER BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K102416 08/24/2010 BD GENEOHM VANR ASSAY BD DIAGNOSTICS SCIENCE RAYMOND BOULE
K102064 08/16/2010 BD FACS SAMPLE PREP ASSISTANT III (SPA III) BECTON DICKINSON & CO. KATY CAMPBELL
K102336 08/18/2010 RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE BOSTON SCIENTIFIC CORPORATION ASHLEY PYLE
K102251 08/09/2010 DASH KNEE BRAINLAB AG ALEXANDER SCHWIERSCH
K102449 08/27/2010 BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM BRIGHT SPINE, INC ROBERT SIMONSON
K102211 08/05/2010 CRUISER 18 GUIDEWIRE BRIVANT, LTD. TOMAS FUREY
K102316 08/16/2010 GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM BROADMASTER BIOTECH CORPORATION ROGER LAI
K102409 08/24/2010 DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 BYRNE MEDICAL INC. JOHN WILLIS
K102391 08/23/2010 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. BARD, INC. SCOTT PEASE
K102405 08/24/2010 INFUSION SET FOR POWERPICC SOLO 2 CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K102159 08/02/2010 POWERPICC SV CATHETERS C.R. BARD, INC. JESSICA AGNELLO
K102165 08/02/2010 STERILE SALINE SOLUTION CACHET PHARMACEUTICALS PVT. LTD. SHIVKUMAR AGRAWAL
K102373 08/20/2010 CALYPSO SYSTEM WITH DYNAMIC EDGE GATING CALYPSO MEDICAL TECHNOLOGIES INC ED VERTATSCHITSCH
K102499 08/31/2010 DUOFERTILITY CAMBRIDGE TEMPERATURE CONCEPTS LTD. SCOTT R MACKIE
K102496 08/31/2010 POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS CARDIAC SCIENCE CORPORATION KATHLEEN ROBERTS
K102147 08/03/2010 CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 CARDIOQUIP LLP DOUGLAS PLATT
K102179 08/03/2010 ENVIEW (TM) CAREFUSION 2200 PATRICIA A AYERS
K102382 08/23/2010 SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT CENDRES & METAUX SA TANJA BONGNI
K102203 08/16/2010 CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS CHEMTRON BIOTECH, INC. JANE ZHANG
K102204 08/05/2010 CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM CHOICE SPINE, LP TODD HAWKINS
K102303 08/16/2010 BLOOD PRESSURE METER, MODEL CH-658 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K102485 08/30/2010 RE-TRACE URETERAL ACCESS SHEATH COLOPLAST A/S BRIAN SCHMIDT
K102216 08/06/2010 XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K102339 08/18/2010 CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE CONMED LINVATEC JAN FLEGEAU
K102410 08/24/2010 MATRYX INTERFERENCE SCREW (5.0-6.5MM) CONMED LINVATEC ASHLEA BOWEN
K102399 08/24/2010 CONSENSUS TAPERSET HIP SYSTEM CONSENSUS ORTHOPEDICS, INC MATTHEW HULL
K102291 08/12/2010 COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN TIM M LOHNES
K102325 08/17/2010 IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA NISHITH DESAI
K102470 08/30/2010 LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, DAVID M HORTON
K102214 08/06/2010 ENDO FLIP CROSPON, LTD. PAUL DRYDEN
K102337 08/18/2010 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE CURON SCIENTIFIC CO., LTD PETER WANG
K102169 08/02/2010 CYBERWAND LITHOTRIPTER CYBERSONICS, INC. JEFF VAITEKUNAS
K102236 08/25/2010 HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L SUSAN PAVELKO
K102320 08/17/2010 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) DAESUNG MAREF CO., LTD. BRANDON CHOI
K102494 08/31/2010 THE BUZZ FACIAL TONING SYSTEM DAKA INTERNATIONAL LTD. BOB WAGNER
K102308 08/16/2010 SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS DENTIUM CO., LTD. EUNKYUNG SON
K102443 08/26/2010 INTRAFIX TIBIAL SHEATH DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K102298 08/13/2010 TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K102423 08/25/2010 DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. BRANDON HIPSHER
K102249 08/09/2010 EXPEDIUM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY DAPHNEY GERMAIN
K102188 08/10/2010 CYBOW READER, MODELS 300 & 720 DFI CO., LTD. YANG HO-DONG
K102400 08/24/2010 SYPHILIS HEALTH CHECK DIAGNOSTICS DIRECT, LLC. GARY LEHNUS
K102432 08/26/2010 DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, DIAZYME LABORATORIES ABHIJIT DATTA
K102255 08/25/2010 DMP ETCHING GEL DMP LTD DIMITRIS PRANTSIDIS
K102252 08/25/2010 DMP PIT & FISSURE SEALANT DMP LTD DIMITRIS PRANTSIDIS
K102254 08/25/2010 DMP SINGLE BONDING DMP LTD DIMITRIS PRANTSIDIS
K102257 08/25/2010 NANOCERAM- BRIGHT DMP LTD DIMITRIS PRANTSIDIS
K102408 08/23/2010 DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM CORPORATION CHARLIE MACK
K102474 08/30/2010 FLAATZ 750E DRTECH CORP. BEOM-JIN MOON
K102420 08/25/2010 EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K102200 08/04/2010 INTEGRITY MODEL 1014284 ELEKTA LTD. ANDREW HEDGES
K102368 08/20/2010 NON-ABLATIVE WRINKLE TREATMENT HANDPIECE ELLMAN INT'L INC. JONATHAN ACHENBACH
K102343 08/17/2010 EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM EMERGE MEDICAL CURTIS RAYMOND
K102202 08/04/2010 GS 3000 EMSI CHERITA JAMES
K102366 08/20/2010 FINESS ENDOSCOPE ENTELLUS MEDICAL, INC. KAREN E PETERSON
K102270 08/10/2010 ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN ENVITEC-WISMAR GMBH STEPHEN GORSKI
K102345 08/31/2010 EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K102215 08/06/2010 KIRSCHNER WIRES, STEINMAN PINS EVERGREEN ORTHOPEDIC RESEARCH LAB WAYNE MORSE
K102487 08/30/2010 NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 EXACTECH, INC. VLADISLAVA ZAITSEVA
K102412 08/30/2010 VISTA DIGITAL OPTHALMOSCOPE EYEQUICK.LLC MARC ELLMAN MD
K102167 08/02/2010 LO-50 LED LIGHT SOURCE FIBEROPTICS TECHNOLOGY, INC. ALLAN GUILLOTTE
K102314 08/16/2010 3M INTEGRATED CYCLER (110V) & (220V) FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K102170 08/03/2010 SIMPLEXA FLU A/B & RSV FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K102245 08/09/2010 CARE ZY5BA OXYGEN CONCENTRATOR FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. KATHY GUO
K102466 08/30/2010 FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR FUJINON, INC. CURTIS RAYMOND
K102260 08/10/2010 FDI GLUCOSE CONTROL SOLUTIONS FUJIREBIO DIAGNOSTICS, INC KENT PRUETT
K102239 08/09/2010 CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY PAIVI ROIHA
K102389 08/23/2010 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY MONICA MORRISON
K102388 08/23/2010 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K102393 08/23/2010 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K102256 08/10/2010 GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K102426 08/25/2010 CARESCAPE MODEL V100 VITAL SIGNS MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARY CARTER
K102231 08/09/2010 DISCOVERY NM 750B GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ELI WERNER
K102307 08/16/2010 GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS GENOSS CO., LTD. EUNKYUNG SON
K102299 08/18/2010 CPR FACE MASK GENUINE FIRST AID LLC GARY LEHNUS
K102242 08/09/2010 OSOM C. DIFFICILE TOXIN A/B TEST GENZYME CORPORATION CAROL C RYERSON
K101250 08/12/2010 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES GIVEN IMAGING LTD. TIM THOMAS
K102355 08/19/2010 ZIP'R MANTIS POWERED WHEELCHAIR GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102358 08/19/2010 ZIP'R3/ ZIP'R3 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102361 08/19/2010 ZIP'R4/ ZIP'R4 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102172 08/02/2010 MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K102293 08/13/2010 CALIBER SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K102392 08/23/2010 MICROFUSE PUTTY AND MICROFUSE ST MIS GLOBUS MEDICAL INC. KELLY J BAKER PH.D.
K102313 08/16/2010 PATRIOT TRANSCONTINENTAL M SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
K102195 08/04/2010 SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBUS MEDICAL, INC. KELLY J BAKER
K102278 08/11/2010 QUADRA BLOC TENS PLUS GRADIENT TECHNOLOGIES, LLC JOHN TOWNSEND
K102223 08/06/2010 CHALLENGE-EVER HALLIM DENTECH CO., LTD. PRISCILLA CHUNG
K102168 08/02/2010 SENSEI X ROBOTIC CATHETER SYSTEM HANSEN MEDICAL, INC. KATE WHITIN
K102305 08/16/2010 HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P HASS CORP. PRISCILLA CHUNG
K102459 08/27/2010 NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE HEMOSTASIS, LLC BERNARD HORWATH
K102428 08/26/2010 WUNDER TEST HIEN HELEN NGUYEN HIEN NGUYEN
K102282 08/12/2010 THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE FITTS
K102360 08/19/2010 ICESENCE 3 ICECURE MEDICAL LTD. ELISABETH SADKA
K102286 08/12/2010 CRAG LATERAL FLOW ASSAY (CRAG LFA) IMMUNO-MYCOLOGICS, INC. SEAN BAUMAN
K102281 08/11/2010 THERMAL MASSAGE BED, MODEL 2D-GX INAREX CORPORATION EILEEN YANG
K102248 08/09/2010 EXCELLA II SPINAL SYSTEM MODEL EC2-00 INNOVASIS, INC. MARSHALL C MCCARTY
K102164 08/02/2010 HEMOSIL PROTEIN S ACTIVITY ASSAY INSTRUMENTATION LABORATORY CO. JACQUELINE EMERY
K102258 08/10/2010 CUSA NXT EXTENDED LENGTH TIP INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K102364 08/20/2010 NYDIAG 200 INTERACOUSTICS A/S ERIK NIELSEN
K102461 08/27/2010 FRACTORA INVASIX LTD. AMIR WALDMAN
K102266 08/10/2010 ISOLED AC-POWERED LED HEADLIGHT SYSTEM ISOLUX LLC NIKOLAUS ANDREOULAKIS
K102372 08/20/2010 OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO CHEN XI
K102362 08/19/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU HUAYUAN GLOVES CO., LTD. YU BANG TING
K102480 08/30/2010 INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA JIEYING LABORATORY INC. GRACE HOLLAND
K102190 08/03/2010 WINSTIM JOHARI DIGITAL HEALTHCARE, LTD. NISHA JOHARI
K102327 08/17/2010 CLEARVISION DR 7000F JPI HEALTHCARE CO., LTD WILLIAM LITTLE
K102229 08/09/2010 PULMOTRACK 2020 SYSTEM KARMELSONIX YORAM LEVY
K102163 08/02/2010 REALSEAL XT SEALER KERR CORPORATION WENDY GARMEN
K102349 08/19/2010 AERODR SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K102442 08/26/2010 E.S.O. (ELECTRO SENSOR OXI) L.D. TECHNOLOGY, LLC ALBERT MAAREK
K102166 08/02/2010 ELECTRO INTERSTITIAL SCAN L.D. TECHNOLOGY, LLC RICHARD CLEMENT
K102463 08/30/2010 "GOOD NIGHT" LARRY V CONNELL, DMD EILEEN CONNELL
K102439 08/26/2010 FUNNEL GUIDE CATHETER MODEL G1020608 LAZARUS EFFECT, INC CARRIE NEUBERGER
K102265 08/10/2010 LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM LDR SPINE USA BECKINAM NOWATZKE
K102331 08/17/2010 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM LDR SPINE USA BECKINAM NOWATZKE
K102295 08/13/2010 X2ABS DUAL CHANNEL FITNESS BELT LETO ENTERPRISES INCORPORATION SABRINA WEI
K102484 08/30/2010 SEQURE SNARE SYSTEM LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. SHI XIAOLI
K102210 08/05/2010 LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K102464 08/27/2010 QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K102182 08/03/2010 MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 MAQUET CRITICAL CARE AB WHITNEY TORNING
K102263 08/10/2010 HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 MCKESSON INFORMATION SOLUTIONS LLC STEVEN B DATLOF
K102218 08/06/2010 COMPACT PIEZO P2K, POWERCARE MECTRON S.P.A. ROGER GRAY
K102437 08/26/2010 GMK REVISION KNEE SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K102237 08/09/2010 PVS MODEL 1.0 MEDCOM GMBH STEFAN WALTER
K102222 08/06/2010 ULTIMATE VIT ENHAMCER (UVE) MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. LINDA UPTON
K102285 08/12/2010 KRYSTALRAD (ATAL8) MEDICATECH USA JOHN ROSS
K102284 08/12/2010 KRYSTALRAD 560 (FLAATZ 560) MEDICATECH USA JOHN ROSS
K102177 08/02/2010 SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K102397 08/24/2010 KYPHON XPEDE BONE CEMENT MEDTRONIC MARY ROSE
K102176 08/03/2010 FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 MEDTRONIC CRYOCATH LP KARI LAHTI
K102375 08/20/2010 LUCIA MERIDIAN CO., LTD. VINOD PODICHETTY
K102273 08/11/2010 MERIT BIPOLAR COAGULATION PROBE MERIT MEDICAL SYSTEMS, INC. DAN W LINDSAY
K102178 08/13/2010 EASY TOUCH MHC MEDICAL PRODUCTS DANIEL KAMM
K102342 08/18/2010 KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT MICROPHAGE, INC. DREW SMITH
K102365 08/20/2010 MICROPLEX COIL SYSTEM- COSMOS MICROVENTION, INC. LARAINE PANGELINA
K102471 08/30/2010 AS3700 ANESTHSIA DELIVERY SYSTEM MINDRAY DS USA, INC. RUSSELL OLSEN
K102452 08/27/2010 DEFOGGING AND CLEANING SOLUTION- FLO-X MINIMALLY INVASIVE DEVICES LLC MARK L FRIEDMAN, PH.D
K102173 08/02/2010 MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 MOLDEX/METRIC, INC. MARK MEINECKE
K102433 08/26/2010 MOORVMS-PRES PRESSURE CUFF CONTROLLER MOOR INSTRUMENTS LTD. XIABING HUANG
K102206 08/05/2010 ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 MORTARA INSTRUMENT, INC. CHARLES MORREALE
K102369 08/20/2010 PICCOLO COMPOSITE NAILING SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD. YAEL RUBIN
K102131 08/04/2010 NANO-CHECK AMI CTNI CARDIAC MARKER TEST NANO-DITECH CORPORATION YOUNG HOON KIM
DEN100023 08/20/2010 AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES, DAVID WISE
K102435 08/26/2010 BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K102376 08/20/2010 NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 NIHON KOHDEN CORP. STEVE GEERDES
K102436 08/26/2010 NOBEL ACTIVE 3.0 NOBEL BIOCARE AB HERBERT CRANE
K102350 08/19/2010 PULSE OXIMETER NONIN MEDICAL, INC. LORI M MITCHELL
K102385 08/23/2010 NORFOLK MEDICAL NORPORT FAMILY OF PORTS NORFOLK MEDICAL PRODUCTS, INC. MICHAEL J DALTON
K102473 08/30/2010 MULLINS-X PTV CATHETER NUMED, INC. NICHELLE LAFLESH
K102379 08/25/2010 LTF-Y0009; MAJ-YOO41; XOEV-3D1 OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER, M.S. RAC
K102322 08/20/2010 STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) OMNI SURGICAL, L.P. J. D WEBB
K102492 08/31/2010 P200MAAF OPTOS PLC HOWARD M HOLSTEIN
K102201 08/04/2010 CONTOURS LAPIDUS PLATING SYSTEM ORTHOFIX INC. MARY BIGGERS
K102208 08/05/2010 NANOGEN ORTHOGEN, LLC HAROLD ALEXANDER
K102438 08/27/2010 PRIMALOK FACET FIXATION SYSTEM OSTEOMED L.P. KAREN E WARDEN
K102482 08/30/2010 FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM OSTIAL CORPORATION ERIC ANKERUD, JD
K102326 08/17/2010 PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC BARION BRACY
K102162 08/02/2010 PARCUS PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC BARTON BRACY
K102495 08/31/2010 M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 PHILIPS MEDICAL SYSTEMS THERESA POOLE
K102344 08/18/2010 MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K102184 08/04/2010 MEDPOR CONTAIN CAN IMPLANT POREX SURGICAL, INC. STEPHANIE FULLARD
K102198 08/04/2010 COMPACT TOUCH STS QUANTEL MEDICAL S.A. MIKE JOHNSON M.D.
K102175 08/02/2010 RAPIDVUE HCG TEST QUIDEL CORPORATION MICHELLE BODIEN
K102477 08/30/2010 NO!NO! SKIN RADIANCY (ISRAEL) LTD. ROTHMAN JULIA
K102187 08/03/2010 RII INFRARED EAR THERMOMETER, RADIANT INNOVATION, INC. JAMES HUANG
K102346 08/19/2010 RANDOX DIGOXIN ASSAY RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K102348 08/19/2010 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T RAPID BIOMEDICAL GMBH ARMIN PUREA
K102224 08/06/2010 PIXI PEDIATRIC MASK RESMED LTD. DAVID D'CRUZ
K102454 08/27/2010 I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. PAUL DRYDEN
K102465 08/27/2010 BIPAP AVAPS VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ELAINE LARKIN
K102418 08/25/2010 REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM REVERSE MEDICAL CORPORATION AMY ESKINA
K102267 08/09/2010 ELECSYS FERRITIN CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
K102269 08/09/2010 ELECSYS IGE CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
K102445 08/26/2010 ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS ROSTAM LTD. ROBERT J STAAB
K102403 08/25/2010 SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL SAM MEDICAL PRODUCTS JACK N MCCUTCHEON
K102321 08/17/2010 DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP SAMSUNG MOBILE DISPLAY CO., LTD DAVE KIM
K102161 08/02/2010 BLUE SAIL INNOVATION SHANDONG BLUE SAIL INNOVATION CO., LTD. YONGCHEN ZHANG
K102160 08/02/2010 STRETCH VINYL EXAMINATION GLOVE POWDER FREE SHANDONG BLUE SAIL INNOVATION CO., LTD. YONGCHEN ZHANG
K102328 08/17/2010 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. DIANA HONG
K102317 08/16/2010 IQ VENTILATION NASAL MASK SLEEPNET CORPORATION PAUL DRYDEN
K102180 08/02/2010 RHEAD RADIAL HEAD EXTENDED STEMS SMALL BONE INNOVATIONS, INC. JAMES O'CONNOR
K102219 08/18/2010 SOCORRO SMI TUNNEL RELEASE DEVICE SOCORRO MEDICAL, INC. ED DIAO
K102458 08/27/2010 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. SAEYOUNG AHN
K102390 08/23/2010 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. JESSICA R STENBERG
K102199 08/04/2010 OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) SOPHONO, INC CLAY ANSELMO
K102422 08/25/2010 SPACELABS MEDICAL PATIENT MONITORS SPACELABS MEDICAL INC. DAVID J GERAGHTY
K102315 08/16/2010 STAXX XDL SYSTEM SPINE WAVE, INC. DENISE DUCHENE
K102488 08/31/2010 APEX SPINE SYSTEM W/ COCR RODS SPINECRAFT LLC AMI AKALLAL-ASAAD
K102363 08/20/2010 SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K102490 08/31/2010 IGX PLEX CELIAC QUALITATIVE ASSAY SQI DIAGNOSTICS SYSTEMS KATE SMITH
K102394 08/23/2010 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION ROBERT SULLIVAN
K102330 08/17/2010 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION ROBERT F SULLIVAN
K102244 08/09/2010 RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS CORPORATION ROBERT F SULLIVAN
K102217 08/06/2010 SYSTEM 1E CHEMICAL INDICATOR STERIS CORPORATION ROBERT F SULLIVAN
K102462 08/27/2010 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS CORPORATION ROBERT SULLIVAN
K102296 08/13/2010 VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) STERIS CORPORATION ROBERT SULLIVAN
K102469 08/30/2010 VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR STERIS CORPORATION ROBERT SULLIVAN
K102235 08/09/2010 MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM STRYKER SPINE CURTIS TRUESDALE
K102460 08/27/2010 AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH SUMMIT MEDICAL PRODUCTS, INC MARKO VAN AMEN
K102483 08/30/2010 SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 SUNSET HEALTHCARE SOLUTIONS, LLC KEVIN WALLS
K102095 08/16/2010 SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC CURTIS RAYMOND
K102207 08/05/2010 FIBER FORCE SYNCA MARKETING, INC. DAVE KIM
K102456 08/27/2010 INTRAORAL BELSENSOR GOLD TAKARA BELMONT USA, INC. ROBERT SCHIFF
K102431 08/26/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN FUQIANG GLOVE CO., LTD. CHU XIAOAN
DEN100017 08/09/2010 LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) TEARSCIENCE, INC. CHRISTY MOENY
K102238 08/09/2010 ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER TELEFLEX MEDICAL, INC. SUZANNE SCHORLE
K102253 08/09/2010 ECHO BLASTER TELEMED YURY SOKOLOV
K102230 08/09/2010 NUGARD NITILE GREY COLOR TERANG NUSA SDN BHD ROBERT HILL
K102323 08/17/2010 CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC DALE DAVISON
K102275 08/11/2010 THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 THERMEDX, LLC JOHN R SCOVILLE
K102067 08/11/2010 ENDOSKELETON TO TITAN SPINE, LLC RICH JANSEN
K102489 08/31/2010 VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN PAUL BIGGINS
K102334 08/17/2010 TRANS1 AXIALIF PLUS TRANS1 INCORPORATED CHERYL WAGONER
K102430 08/26/2010 TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET TYCO ELECTRONICS CORPORATION DENNIS M GILKEY
K102367 08/20/2010 OPTIGEN TOTAL KNEE SYSTEM U&I CORP. GYEONG-JE KWON
K102467 08/30/2010 UTA AND UHA UTA ANGELA BLACKWELL
K102212 08/06/2010 D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER VASCULAR SOLUTIONS, INC. LISA GALLATIN
K102259 08/10/2010 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD. DAVE KIM
K102378 08/20/2010 VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI VECTRACOR, INC BRAD S SCHRECK
K102404 08/24/2010 PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) VENTUS MEDICAL, INC. MICHAEL NEVARES
K102277 08/11/2010 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K102476 08/30/2010 TELERADPRO VIDAR SYSTEMS CORP. CARRIE L BRANCART
K102413 08/24/2010 FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL VILEX, INC. ABE LAVI
K102401 08/24/2010 HEMI IMPLANT; MINI HEMI IMPLANT VILEX, INC. SYLVIA SOUTHARD
K102341 08/18/2010 VIPI BLOCK VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE KEVIN WALLS
K102351 08/19/2010 GRANDIO SO VOCO GMBH MANFIELD T PLAUMANN
K102354 08/19/2010 GRANDIO SO HEAVY FLOW VOCO GMBH T GERKENSMEIER
K102347 08/19/2010 GRANDTEC VOCO GMBH T GERKENSMEIER
K102450 08/27/2010 IONOLUX PRO VOCO GMBH MANFRED T PLAUMANN
K102419 08/25/2010 GSP NEONATAL IRT KIT (3306-001U) WALLAC OY, SUBSIDIARY OF PERKINELMER SUSAN K HAMANN
K102104 08/13/2010 GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM WIPRO GE HEALTHCARE PRIVATE, LTD. BRYAN BEHN
K102319 08/17/2010 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 WON INDUSTRIAL CO. BRANDON CHOI
K102324 08/17/2010 ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. SARAH HOLTGREWE
K102380 08/23/2010 EVOLUTION MP TOTAL KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. RYAN ROSS
K102352 08/19/2010 EVOLVE EPS ORTHOLOC WRIGHT MEDICAL TECHNOLOGY, INC. KELSEY LEE
K102429 08/25/2010 ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW WRIGHT MEDICAL TECHNOLOGY, INC. MEGAN MCCAGH
K102171 08/02/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES WUXI BINGFA GAINLITE GLOVES CP., LTD CHENGYU SHEN
K102425 08/25/2010 ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K102283 08/13/2010 ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K102191 08/03/2010 TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
K102444 08/26/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO YINGBO MEDICAL PRODUCTS, INC. FRANK LIU
K102174 08/03/2010 ZOLL PROPAQ M ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS PAUL DIAS
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