FDA 510(k) Applications Received During July, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K092141 07/15/2009 VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 3M ESPE DENTAL PRODUCTS TAMARA L STANCZAK
K092097 07/14/2009 A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH A.B. KORKOR MEDICAL, INC. ANDREW BLACK
K091960 07/01/2009 VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 ABBOTT MOLECULAR, INC. PAMELA L SWATKOWSKI
K092286 07/29/2009 FOX SV PTA CATHETER Abbott Vascular NADINE SMITH
K091999 07/02/2009 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K091993 07/02/2009 RAPID PROGRAMMER, VERSION 3.3.0 ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) MIA M WARE
K092236 07/23/2009 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. PAULA E BULGER
K092166 07/21/2009 S. AUREUS/CNS PNA FISH, MODEL KT005 ADVANDX, INC. PAULA E BULGER
K092143 07/15/2009 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K092238 07/23/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K091995 07/02/2009 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K092086 07/09/2009 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
K092225 07/23/2009 AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR AMYLIOR, INC. ERIC DUGAS
K091997 07/02/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 ANDON HEALTH CO.,LTD LIU YI
K092045 07/06/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 ANDON HEALTH CO.,LTD LIU YI
K092066 07/08/2009 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE ANDREW TECHNOLOGIES, LLC JONATHAN S KAHAN
K091966 07/01/2009 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 ANGIOSCORE, INC. KIMBERLEY KLINE
K092219 07/22/2009 NAVIGATOR CLINICAL GUIDENCE SYSTEM APPLIED PHYSIOLOGY PTY LTD. ROBERT N CLARK
K092182 07/21/2009 VOYAGER COMPACT IMAGING SYSTEM Ardent Sound, Inc. DEBORAH VAN GORDER
K092104 07/14/2009 ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM ARKRAY Factory USA, Inc. HAMID IDRISSI
K092133 07/15/2009 ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N ARTHROCARE CORP. VALERIE DEFIESTA-NG
K092047 07/06/2009 ASCENSION METAL GREAT TOE SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K092233 07/23/2009 SURGIMESH XD ASPIDE MEDICAL HOWARD M HOLSTEIN
K092089 07/09/2009 CLARUJUST AUDIGENCE, INC. CRAIG PAGAN
K092031 07/06/2009 VAPOR-CLEAR, MODEL 100 AXON MEDICAL, INC. JOSEPH ORR
K092313 07/30/2009 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SUSAN OLINGER
K092112 07/14/2009 BTI DENTAL IMPLANT TINY 2.5-3.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ
K092046 07/06/2009 BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K092285 07/29/2009 PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 BEST MEDICAL CANADA LTD. MARY HERBERT
K092296 07/29/2009 POWDER FREE EXAMINATION GLOVE BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092301 07/29/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092302 07/29/2009 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092294 07/29/2009 VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092035 07/06/2009 BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION BICON, LLC VINCENT J MORGAN
K092214 07/22/2009 CHIROPRO L SYSTEM BIEN-AIR DENTAL, SA CYNTHIA J NOLTE
K092223 07/23/2009 MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST BINAX, INC. Angela Drysdale
K091951 07/01/2009 HAMMERLOCK BIOMEDICAL ENT., INC. JOE W SOWARD
K091976 07/01/2009 BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL BIOMET TRAUMA MARGARET CROWE
K092078 07/09/2009 OPTILOCK PERIARTICULAR PLATING BIOMET TRAUMA SHIKHA GOLA
K092150 07/16/2009 COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT BIOMET, INC. SUSAN ALEXANDER
K092052 07/07/2009 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K092064 07/08/2009 SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 BIOSENSE WEBSTER, INC. MELISSA SCHULTZ
K092048 07/07/2009 ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP BIOSITE INCORPORATED Lisa Chicorka
K092197 07/21/2009 PHOTEX30 DIODE LASER SERIES: 980, 810, 940 BIOTEX, INC. ASHOK GOWDA
K092009 07/06/2009 MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 Boston Scientific Corporation JENNIFER KIMBALL
K092149 07/16/2009 BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 BOVIE MEDICAL RICHARD KOZLOFF
K092191 07/21/2009 EXILIS, MODEL 5000 BTL INDUSTRIES LTD RICHARD VINCINS
K092212 07/22/2009 BUSSE SURGICAL DRAPES III BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K092090 07/14/2009 ERBELIFT HAND PUMP AND FLEXIBLE PROBE BYRNE MEDICAL INC. CHRIS HIERHOLZER
K092017 07/06/2009 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) CAPTIVA SPINE, INC MIKE ENSIGN
K092304 07/29/2009 ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K092187 07/21/2009 MAIA, MODEL 1 CENTERVUE SPA GIULIANO BARBARO
K092160 07/16/2009 POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN KENG BENG
K092132 07/15/2009 XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K092298 07/29/2009 MODIFICATION TO MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K091961 07/01/2009 MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K092076 07/09/2009 AEGIS & AEGIS II SPINAL SYSTEM CORENTEC CO., LTD ROBERT SCHIFF
K092198 07/21/2009 CORMET CEMENTLESS RESURFACING FEMORAL HEAD CORIN USA ASHLEA BOWEN
K091971 07/01/2009 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM CORVENTIS, INC. MADHURI BHAT
K092205 07/22/2009 PALINDROME P HEMODIALYSIS CATHETER COVIDIEN LP, FORMERLY REGISTERED AS KENDALL Daniel Campion
K092021 07/06/2009 CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) CRYOLIFE, INC. JOHN D FERROS
K092195 07/21/2009 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC. KATHY MAYNOR
K092032 07/06/2009 BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 DAVOL INC., SUB. C.R. BARD, INC. GAIL DOW
K092030 07/06/2009 ELATION MB METAL REINFORCED PLASTIC BRACKET DENTSPLY INTERNTIONAL HELEN LEWIS
K092122 07/14/2009 GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K091994 07/02/2009 MOUNTAINEER LAMINOPLASTY SYSTEM DEPUY SPINE, INC. DAPHNEY GERMAIN
K092244 07/28/2009 MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS DIAGNOSTIC GROUP LLC DANIEL EGGAN
K092300 07/29/2009 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K092229 07/23/2009 THYRETAIN TM TSI REPORTER BIOASSAY DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K092113 07/14/2009 STA - FREE PS CALIBRATOR DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K092170 07/21/2009 STA LIATEST FREE PS DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K092029 07/06/2009 VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K092062 07/08/2009 EVERON 1.0 EARLYSENSE LTD. DALIA ARGAMAN
K092010 07/06/2009 PC ECG, MODEL SE-1010 EDAN INSTRUMENTS, INC. WILLIAM STERN
K091992 07/02/2009 EIDOSMED, MODEL EDG4.0 EIDOSMED, LLC DANIEL KAMM
K092130 07/15/2009 RASCAL WE GO 250 POWERED WHEELCHAIR ELECTRIC MOBILITY CORP. W. STEPHEN BEVERSLUIS
K092083 07/09/2009 EXTEND FRAME SYSTEM, MODEL 1009633 ELEKTA INSTRUMENT AB ABDERS SKOGLUND
K092033 07/06/2009 VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR ELMED USA JONATHAN WARD
K092289 07/29/2009 EMS AIR-FLOW HANDY PERIO EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J NOLTE
K091956 07/01/2009 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 ENCORE MEDICAL, L.P. ELIZABETH ONDERLINDE
K092144 07/15/2009 BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K092174 07/21/2009 ENABLER-P CATHETER SYSTEM, MODEL 3000 ENDOCROSS, LTD. JOHN SMITH
K092111 07/14/2009 ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 ENTOMED AB CHARLOTTE MATTISSON
K092202 07/22/2009 ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT ESWALLOW USA DANIEL KAMM
K091969 07/01/2009 EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K092299 07/29/2009 TRAILBLAZER SUPPORT CATHETER EV3 INC DAVID ROBERTSON
K092172 07/21/2009 EXEL I.V. EXTENSION SET EXELINT INTL. CO. ARMAND HAMID
K092297 07/29/2009 ELETONE CREAM FERNDALE PHARMA GROUP, INC. RICHARD A HAMER
K092192 07/21/2009 WAYPOINT STEREOTACTIC SYSTEM FHC, INC. LEE D MARGOLIN
K092257 07/28/2009 JALOSKIN FIDIA ADVANCED BIOPOLYMERS SRL SHARON A SEGAL
K092218 07/22/2009 FLEXICARE BREATHING FILTERS FLEXICARE MEDICAL LTD. DAVID MOYNHAM
K092175 07/21/2009 THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 FLOWCARDIA, INC. Dustin Michaels
K092189 07/21/2009 POGO SCREW FXDEVICES RICH LIPSCHUTZ
K092020 07/06/2009 AADVA ZR COLORING LIQUID GC AMERICA INC. MARK HEISS
K092004 07/02/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE HEALTHCARE ALAN TOTAH
K092271 07/28/2009 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE HEALTHCARE NICOLE LANDREVILLE
K092027 07/06/2009 CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOEL C KENT
K092140 07/15/2009 GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. JAMES TURNER
K092079 07/09/2009 MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. JAMES T TURNER
K092231 07/23/2009 GEBDI TRIBOS 501 GEBDI DENTAL-PRODUCTS GMBH THOMAS BISKUPSKI
K092061 07/08/2009 FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 GENEXEL MEDICAL INSTRUMENT INC JAY MANSOUR
K092171 07/21/2009 VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. JAE KIM
K091958 07/01/2009 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM GLENVEIGH SURGICAL, LLC PENNY NORTHCUTT
K092108 07/14/2009 TRUSS THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K092146 07/15/2009 XTEND ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K092072 07/08/2009 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE GX CORPORATION SDN BHD FOO KHON PU
K092200 07/22/2009 POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) GX CORPORATION SDN BHD FOO KHON PU
K092278 07/28/2009 GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K092240 07/23/2009 ACUPUNCTURE NEEDLES HAENGLIM SEOWON MEDICAL CO. JEAN ASQUITH
K092148 07/15/2009 HAMILTON-C2 HAMILTON MEDICAL AG JOERG SCHNEIDER
K092053 07/07/2009 MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH HANDPIECE HEADQUARTERS TIM ROPCHAN
K092163 07/16/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB HEALTH & LIFE CO., LTD. SARAH SU
K092161 07/16/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF HEALTH & LIFE CO., LTD. SARAH SU
K092155 07/16/2009 HEARTWAY POWER MOBILITY SCOOTER, S8 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K092154 07/16/2009 HEARTWAY POWER MOBILITY SCOOTER, S9 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K092037 07/06/2009 LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. Cindy Green
K092245 07/28/2009 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 HONSUN (NANTONG) CO., LTD David Zhang
K091955 07/01/2009 STRYKER SONICPIN SYSTEM HOWMEDICA OSTEONICS CORP AVITAL MERL-MARGULIES
K092178 07/21/2009 AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092018 07/06/2009 OMNIPRO INCLINE IBA DOSIMETRY GMBH CHUCK LINDLEY
K092307 07/30/2009 IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR IMASIGHT INC JEAN CASAULT
K092261 07/28/2009 DEFCON TSA/TSH DENTAL IMPLANT SYSTEM IMPLADENT, S.L. JOSE-RAMON GUTIERREZ
K091963 07/01/2009 VIGILANT EEG MONITOR, VIGILANT 2.0 INFINITE BIOMEDICAL TECHNOLOGIES, LLC MANAN HATHI
K091980 07/01/2009 ACL TOP 700 LAS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K092181 07/21/2009 HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K092227 07/23/2009 JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS INTEGRA LIFESCIENCES CORP. JENNIFER BOSLEY
K091975 07/01/2009 INTEGRATED LABORATORY AUTOMATION SOLUTION INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. MARIA F GRIFFIN
K092306 07/29/2009 SECURACATH UNIVERSAL INTERRAD MEDICAL, INC. JONATHAN KAHAN
K092129 07/15/2009 INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 INTERSURGICAL, INC. MICHAEL ZALEWSKI
K092177 07/21/2009 MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 INVATEC S.P.A. STEVE CAMP
K092136 07/15/2009 PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 ISORAY MEDICAL, INC. FRED SWINDLER
K091985 07/02/2009 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K092211 07/22/2009 CHESAPEAKE SPINAL SYSTEM K2M, INC. RICHARD WOODS
K091968 07/01/2009 KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K092176 07/21/2009 TAKE 1 ADVANCED RIGID TRAY KERR CORPORATION Wendy Garman
K092025 07/06/2009 FLUID FILLED TEETHER - GEL KIDS II BOB COUGHLIN
K092167 07/21/2009 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 KIMBERLY-CLARK CORP. THOMAS KOZMA
K092281 07/29/2009 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KIYOYUKI ARIKAWA
K092194 07/21/2009 POLYBONE DENTAL KYUNGWON MEDICAL CO., LTD. JOYCE BANG
K092153 07/16/2009 SKYLINE 55, MODEL VER 1 LARSEN & TOUBRO LIMITED SHAILESH BHOSALE
K091987 07/02/2009 ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP LEMAITRE VASCULAR, INC. ERIN E DALY
K092291 07/29/2009 SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH ELAINE DUNCAN
K091981 07/01/2009 LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER LIGHTMED CORP. ANITA CHEN
K091962 07/01/2009 POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 LUMENIS, INC. MIKE AYMAMI
K091998 07/02/2009 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP MAKO SURGICAL CORP. WILLIAM TAPIA
K091967 07/01/2009 MEDACTA BIPOLAR HEAD MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K092265 07/29/2009 VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS MEDACTA INTERNATIONAL, SA NATALIE KENNEL
K092038 07/06/2009 APTUS K-WIRE SYSTEM MEDARTIS AG KEVIN THOMAS
K091954 07/01/2009 MICRO-STICK SET MEDCOMP Susan Pileggi
K091953 07/01/2009 PRO-PICC MEDCOMP JEAN CALLOW
K091991 07/02/2009 EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 MEDICA CORP. Photios Makris
K092116 07/14/2009 EASYCELL CELL LOCATOR MEDICA CORP. FRAN WHITE
K092284 07/29/2009 LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 MEDICAL DEVICE RESOURCE CORP. MELBOURNE KIMSEY
K092023 07/06/2009 NAVIJECT SUB2-1P, MODEL: LP604430 MEDICEL AG GEORGE MYERS
K092159 07/16/2009 ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. SHIM KYUNG-AM
K092250 07/28/2009 MEDLINE RED RUBBER URETHRAL CATHETER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K092239 07/23/2009 ROSA SURGICAL DEVICE, MODEL ROSA 1.1 MEDTECH S.A. BERTIN NAHUM
K092308 07/30/2009 POLESTAR, MODEL N-30 MEDTRONIC NAVIGATION ISRAEL, LTD. YAIR PENIAS
K092087 07/09/2009 MEDTRONIC DENTAL TCP MEDTRONIC SOFAMOR DANEK USA, INC. PAMELA EDWARDS
K091974 07/01/2009 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K092303 07/29/2009 MERIT LAUREATE HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K092096 07/14/2009 ENDOFORM DERMAL TEMPLATE MESYNTHES LTD MARY MCNAMARA
K092051 07/07/2009 THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 MICROGENICS CORP. LISA CHARTER
K092207 07/22/2009 RESTORELLE POLYPROPYLENE MESH MPATHY MEDICAL DEVICES INC CAROLINE STRETTON
K092203 07/22/2009 OMNISURE URETHRAL SLING, MODEL OTK52 MPATHY MEDICAL DEVICES, LTD. CAROLINE STRETTON
K092003 07/02/2009 CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE MyCardio, LLC ROBERT SCHUEPPERT
K092292 07/29/2009 CHECKPOINT NDI MEDICAL LLC JULIE GRILL
K092085 07/09/2009 ISPIRA RESUSCITATION UNIT NEOFORCE GROUP, INC. MONICA FERRANTE
K092235 07/23/2009 BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K092237 07/23/2009 NSM-S15 SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K091952 07/01/2009 ACTA VESSEL OCCLUSION SYSTEM (VOS) NFOCUS NEUROMEDICAL, INC. BOB O'HOLLA
K092107 07/14/2009 VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 NIDACON INTERNATIONAL AB DANIEL KAMM
K091978 07/01/2009 DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO. LTD. FUMIAKI KANAI
K092246 07/28/2009 NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 NIPRO MEDICAL CORPORATION JESSICA OSWALD
K092101 07/14/2009 REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES NONIN MEDICAL, INC. LORI ROTH
K092102 07/14/2009 NORDICBRAINEX SOFTWARE, VERSION 1.0 NORDICIMAGINGLAB AS CHANDANA GURUNG BHANDARI
K092253 07/28/2009 MODIFICATION TO FMRI HARDWARE SYSTEM NORDICNEUROLAB CHANDANA GURUNG BHANDARI
K092011 07/06/2009 NORM SPINAL SYSTEM NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR NURAY DOGAN
K092224 07/23/2009 TIGR SURGICAL MESH , MODEL WK-6 NOVUS SCIENTIFIC PTE LTD KELVIN KOH
K092287 07/29/2009 NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM NUVASIVE, INC. Sheila Bruschi
K092309 07/30/2009 SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K092014 07/06/2009 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION
K092039 07/06/2009 IDENTEVENT, VERSION 1.0G OPTIMA NEUROSCIENCE, INC. PAULA WILKERSON
K092056 07/07/2009 OPTOMED SMARTSCOPE, MODEL M3-1 EY1 OPTOMED OY LAURA OJALA
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K092295 07/29/2009 PIONEER POSTERIOR CERVICO-THORACIC SYSTEM PIONEER SURGICAL TECHNOLOGY EMILY M DOWNS
K091965 07/01/2009 POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
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K091964 07/01/2009 CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS PROCTER & GAMBLE CO. VICTORIA P SCHOFIELD
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K092040 07/02/2009 PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 R4 VASCULAR, INC. LAURIE LEWANDOWSKI
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K092269 07/28/2009 CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET RANDOX LABORATORIES, LTD. P ARMSTRONG
K092268 07/28/2009 RANDOX BARITURATES ASSAY RANDOX LABORATORIES, LTD. P ARMSTRONG
K092274 07/28/2009 RANDOX BENZODIAZEPINE ASSAY RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K092275 07/28/2009 RANDOX ECSTASY (MDMA) ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
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K092258 07/28/2009 RANDOX METABOLITE (EDDP) ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K092272 07/28/2009 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K092266 07/28/2009 RANDOX METHAMPHETAMINE ASSAY RANDOX LABORATORIES, LTD. P ARMSTRONG
K092125 07/15/2009 PRESIDIO PACS REAONIX SECURITY, LLC GERALD JACKSON
K092026 07/06/2009 EASYCARE TX, TX LINK RESMED LTD. DAVID D'CRUZ
K092186 07/21/2009 VPAP TX RESMED LTD. DAVID D'CRUZ
K092217 07/22/2009 MERCURY VCO2 RESPIRONICS NOVAMETRIX, INC. KEVIN MADER
K092043 07/06/2009 BIPAP SYNCHRONY 2 RESPIRONICS, INC. ZITA YURKO
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K092070 07/08/2009 INTERPLATE C RSB SPINE LLC. KAREN E WARDEN
K092049 07/07/2009 IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT SAINATH INTELLECTUAL PROPERTIES, LLC CHRISTOPHER PARADIES
K092251 07/28/2009 BIODENTINE SEPTODONT WAYNE MATELSKI
K091950 07/01/2009 SMART-WELL EZTEST INCUBATOR SGM BIOTECH, INC. JOHN R GILLIS
K092000 07/02/2009 POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. JOHN ZHAO
K092164 07/16/2009 TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA SHENZHEN DELICATE ELECTRONICS CO., LTD. WILLIAM STERN
K092022 07/06/2009 TISSU TRANS HARVEST TUBING SHIPPERT MEDICAL TECHNOLOGIES CORP. SARAH L SHIPPERT
K092067 07/09/2009 ABVS WORKPLACE SIEMENS AG, MEDICAL SOLUTIONS SHELLY PEARCE
K092013 07/06/2009 SYNGO VOLUME PERFUSION-CT BODY SIEMENS AG, MEDICAL SOLUTIONS
K092283 07/29/2009 DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN ANN DRAY-LYONS
K091949 07/01/2009 MICROSCAN MICROSTREP PLUS, MODEL B1027-201 SIEMENS HEALTHCARE DIAGNOSTICS SHANNON POPSON
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K092145 07/15/2009 160MLC OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
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K092002 07/02/2009 AFGHAN EXTERNAL FIXATOR SMITH & NEPHEW, INC. LAURA SEJNOWSKI
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K092015 07/06/2009 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K092256 07/28/2009 THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 SMITHS MEDICAL ASD, INC. PAT MCLEISH
K092156 07/16/2009 CAD 12, COLONOSCOPY ASSIST DEVICE SOFTSCOPE MEDICAL TECHNOLOGIES, INC. BERNARD HORWATH
K092162 07/16/2009 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM SOLCO BIOMEDICAL CO., LTD. SAEYOUNG AHN
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K092058 07/08/2009 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K092315 07/30/2009 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR SORIN GROUP ITALIA S.R.L. BARRY SAIL
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K092128 07/15/2009 MODIFICATION TO: PSS SYSTEM SPINAL USA JEFFREY JOHNSON
K092193 07/21/2009 SPINAL USA INTERBODY CAGES SPINAL USA JEFFREY JOHNSON
K092142 07/15/2009 SPORT-ELEC BODY CONTROL SYSTEM BS SPORT-ELEC KIMBERLY JONES
K092310 07/29/2009 SEGUIN ANNULOPLASTY RING ST. JUDE MEDICAL THOMAS RADEMACHER
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K092138 07/15/2009 JTS EXTENDEABLE IMPLANT STANMORE IMPLANTS WORLDWIDE LTD. GERARD J PRUD'HOMME
K092016 07/06/2009 SUPER-FINE PEN NEEDLE STAT MEDICAL DEVICES, INC. MARY L JEAN
K092134 07/15/2009 STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) STATRAD, LLC
K092041 07/07/2009 STELLAR FIDUCIAL MARKER, MODEL GFMIA STELLAR MEDICAL LLC. BENJAMIN ROEDELL
K092158 07/16/2009 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. DENNIS TOUSSAINT
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K092019 07/06/2009 MODEL 1014 PC ELECTROMETER SUN NUCLEAR CORP. NOEL DOWNEY
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K092082 07/09/2009 SYNERGY CANNULATED SCREW SYSTEM SYNERGY SURGICAL TECHNOLOGIES, LLC KEVIN THOMAS
K092190 07/21/2009 SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS SYNTHES (USA) JILL R YELTON
K092247 07/28/2009 SYNTHES LOCKING HAND PLATES SYNTHES (USA) SHERI L MUSGNUNG
K092099 07/14/2009 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 TaiDoc Technology Corporation DEBRA LIANG
K092106 07/14/2009 U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 TaiDoc Technology Corporation ERICA LI
K092100 07/14/2009 POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES TANGSHAN HONGXING PLASTIC PRODUCTS CO., LTD. JOHN ZHAO
K092248 07/28/2009 SPI CUSTOMIZABLE GINGIVA FORMER THOMMEN MEDICAL, AG LINDA K SCHULZ
K092230 07/23/2009 MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 TIME MEDICAL LIMITED Diana Hong
K092054 07/07/2009 MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON TOSAMA D.D. ANTONIJA VIDENSEK
K092179 07/21/2009 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K092124 07/15/2009 AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II TRANS1 INCORPORATED CHERYL WAGONER
K092183 07/21/2009 EMBRYOSCOPE AND EMBRYOSLIDE UNISENSE FERTILITECH A/S METTE MUNCH
K092221 07/22/2009 COLONIC SPLINTING OVERTUBE, MODEL 00711145 UNITED STATES ENDOSCOPY GROUP, INC. CRAIG L MOORE
K092103 07/14/2009 DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH CO., LTD. VINCENT LEE
DEN090004 07/22/2009 OVA1 TEST VERMILLION GILLIAN CRUTCHER
K092135 07/15/2009 MODIFICATION TO IVENT 101 VERSAMED MEDICAL SYSTEMS LTD. ADRIANNE LENZ
K091988 07/02/2009 MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K092081 07/09/2009 QXLINK VIEWORKS CO., LTD. CHARLIE MACK
K092280 07/28/2009 CYPHER DICOM PRINT SOLUTION VIRTUAL IMAGING, INC. DANIEL KAMM
K092201 07/22/2009 ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE WRIGHT MEDICAL TECHNOLOGY, INC. SARAH FAIRFIELD
K091989 07/02/2009 PERFADEX AND PERFADEX WITH THAM XVIVO PERFUSION AB KJELL KJORK
K092109 07/14/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) ZHANGJIANGANG ALL FINE RUBBER-PLASTIC PRODUCTS CO.
K091973 07/01/2009 METASUL TAPER LINERS, METASUL FEMORAL HEADS ZIMMER GMBH BENJAMIN C CURSON
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