FDA 510(k) Decisions During July, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K071260 07/17/2007 HERMES BOND 3 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K071131 07/25/2007 UNO 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K070663 07/05/2007 A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT A-DEC, INC. THOMAS H LOUISELL
K070428 07/17/2007 MEDICOM SELF-SEALING STERILIZATION POUCH A.R. MEDICOM, INC. JASON LUDVIG
K071174 07/25/2007 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS ABBOTT SPINE, INC. ZARA OAKES
K070929 07/30/2007 ACON U120 URINE ANALYZER, MODEL U111-101 ACON LABORATORIES, INC. MARTIN O'CONNOR
K070333 07/10/2007 ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL ACRYMED, INC. BRUCE GIBBONS
K071715 07/18/2007 ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K062331 07/10/2007 HIGHPAK-12 AD ELEKTRONIK GMBH GREGORY J MATHISON
K070581 07/13/2007 SILVER ALGINATE II WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED GRAHAME SOMERVILLE
K071393 07/20/2007 JAZZ BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K071972 07/30/2007 ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS AGFA HEALTHCARE CORP. TOM HOLBROOK
K062703 07/23/2007 ONE STEP HCG PREGNANCY TEST AI DE DIAGNOSTIC CO., LTD. LIN WANG
K070636 07/13/2007 AUTOVENT 4000 WITH CPAP ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K062824 07/03/2007 AOS UNIVERSAL CONECTING GUIDE TUBE ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K071186 07/30/2007 MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE AMBU A/S SANJAY PARIKH
K071111 07/17/2007 NON-ABSORBABLE SILK SUTURE ARROW INTL., INC. KARL J NITTINGER
K071622 07/03/2007 ARTHREX FIBERWIRE ARTHREX, INC. ANN WATERHOUSE
K071721 07/13/2007 ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 ASAHI INTECC CO., LTD. YOSHI TERAI
K071602 07/23/2007 IMAGIC V2.0 ASHVA TECHNOLOGIES, PVT. LTD CARL ALLETTO
K043579 07/05/2007 ATRICURE BIPOLAR SYSTEM ATRICURE, INC. ELSA C ABRUZZO, RAC
K070253 07/11/2007 AXYA SUTURE WELDING SYSTEM AND KIT AXYA MEDICAL, INC. HOWARD SCHRAYER
K071664 07/13/2007 TRELLIS-6 PERIPHERAL INFUSION SYSTEM BACCHUS VASCULAR, INC. ANTHONY SOWUNMI
K071745 07/19/2007 BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K070293 07/10/2007 BENVENUE VCF OSTEO COIL SYSTEM BENVENUE MEDICAL, INC. LAURENT SCHALLER
K071675 07/03/2007 LIQUICHEK TUMOR MARKER CONTROL BIO-RAD LABORATORIES MARIA ZEBALLOS
K063495 07/26/2007 C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC. KEVIN WALLS, RAC
K063527 07/30/2007 MBCP+ BIOMATLANTE ADELINE FILLIATRE
K071395 07/09/2007 BIOMET VISION FOOTRING SYSTEM BIOMET MANUFACTURING CORP. ROBERT FRIDDLE
K071498 07/31/2007 SUBTALAR IMPLANT BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K071325 07/26/2007 BIOMET VARIABLE LOCKING PLATE SYSTEM BIOMET TRAUMA SUSAN ALEXANDER
K071569 07/02/2007 ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER BIOMET, INC. ELIZABETH WRAY
K071665 07/18/2007 SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 BIOTRONIK, INC. JON BRUMBAUGH
K062981 07/13/2007 I-CHROMA CRP TEST BODITECH DIAGNOSTICS, INC. GARY LEHNUS
K071309 07/13/2007 BLUE MAX BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. KARI CHRISTIANSON
K071634 07/12/2007 MODIFICATION TO:CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. SHILPA PREM
K071733 07/24/2007 DL900 SERIES HOLTER RECORDER BRAEMAR, INC. DARREN DERSHEM
K070465 07/19/2007 BUSSE EPIDURAL CATHETER BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K071776 07/26/2007 ANEUROPLASTIC, MODEL 43-1290 CODMAN & SHURTLEFF, INC. RACHEL CREME
K071791 07/30/2007 MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 CODMAN & SHURTLEFF, INC. RACHEL CREANE
K071444 07/27/2007 MECHANICAL WHEELCHAIR - L-FRAME SERIES COLOURS 'N MOTION VICTOR R BOX
K071534 07/09/2007 CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS CONFIRMA, INC. PATRICIA A MILBANK
K071640 07/12/2007 VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM COOK, INC. THEODORE HEISE
K070515 07/30/2007 A-VIEW BASIC AND PLUS CORDATEC N.V. BARBARA DEBIASE
K071550 07/18/2007 PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS CP MEDICAL BETSY CORTELLONI
K063133 07/02/2007 CRANIAL SOLUTION ORTHOSIS CRANIAL SOLUTIONS KIRK A LUCYK
K070346 07/18/2007 DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM DADE BEHRING, INC. ROBERT EUSEBIO
K071284 07/26/2007 MODEL SEGAEGO 3D SCOOTER DALTON MEDICAL CORP. WILL RIDGWAY
K071282 07/27/2007 MODEL SEGAEGO 4D SCOOTER DALTON MEDICAL CORP. WILL RIDGWAY
K061495 07/18/2007 VR LUNG ELECTROSONOGRAPH DEEP BREEZE LTD. PHILIP J PHILLIPS
K071334 07/02/2007 DEPUY CAS HEMI ASR HIP INSTRUMENTS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071784 07/25/2007 DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K063772 07/10/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K053095 07/12/2007 HONEY ALGINATE DRESSING DERMA SCIENCES CANADA, INC. SHARMINI ATHERAY
K070811 07/05/2007 CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 DEXCO ROBERT MAZZAFERRO
K070062 07/30/2007 COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE DIESSE DIAGNOSTICA SENESE S.P.A RAUL ALVAREZ
K071701 07/23/2007 TRACKLEAF-10 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K070704 07/13/2007 TRILOGY ANALYZER DREW SCIENTIFIC, INC. CYNTHIA SINCLAIR
K070358 07/30/2007 MAXINSIGHT EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH DANIEL KAMM
K071166 07/23/2007 UNIWEB, VERSION 5.0 ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) ANDY YEW
K071574 07/05/2007 STIFFER COAXIAL MICRO-INTRODUCER KIT ENPATH MEDICAL, INC. PATRICE STROMBERG
K070903 07/02/2007 MYLAB40 ESAOTE EUROPE B.V. CARRI GRAHAM
K070401 07/11/2007 ENDO-CHX ESSENTIAL DENTAL SYSTEMS, INC. SUSAN GOLDSTEIN-FALK
K071581 07/11/2007 BACKPACK MEDICAL OXYGEN SYSTEM ESSEX CRYOGENICS OF MISSOURI, INC. ELIZABETH HUNNICUTT
K063154 07/10/2007 FACIAL RECONSTRUCTIVE MESH (FRM) EVERA MEDICAL, INC. RANDY KESTEN
K071676 07/19/2007 EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS EXACTECH, INC. GRAHAM CUTHBERT
K070299 07/16/2007 EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) EZFIT TECHNOLOGY INC. OU YANG
K071364 07/25/2007 MICROTARGETING GUIDELINE 4000 FHC, INC. LEE D MARGOLIN
K070451 07/31/2007 ABLE CENTRAL VENOUS CATHETER FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD DIANA HONG
K071175 07/17/2007 OHMEDA MEDICAL GIRAFFE OMNIBED GE HEALTHCARE AGATA SMIEJA
K071214 07/31/2007 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING GENESEE BIOMEDICAL, INC. JOHN T WRIGHT
K070689 07/03/2007 LG SPERM FREEZING GENX INTL., INC. MICHAEL D CECCHI
K071022 07/05/2007 POWDER-FREE VINYL EXAMINATION GLOVES GLORMED COLOMBIA S.A. SAM KAO
K070966 07/20/2007 GSO GS1 SPINAL SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K063357 07/10/2007 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K071119 07/24/2007 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) GX CORPORATION SDN BHD FOO KHON PU
K071209 07/25/2007 MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071208 07/30/2007 MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071583 07/25/2007 CERMET III ACETABULAR CUP SYSTEM IMPLANTS INTERNATIONAL, LTD MOHAN EMMANUEL
K070784 07/24/2007 INION BIORESTORE INION OY KATI MARTINEN
K071390 07/20/2007 WHEELCHAIR MODEL STS INNOVATIVE PRODUCTS, INC. JIM STEINKE
K063837 07/02/2007 SIGMA M INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K070608 07/18/2007 SMARTEP, MODEL M010000 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K062616 07/06/2007 WELLNESSPRO 2010 INTELSOURCE GROUP, INC. E.J. SMITH
K062992 07/27/2007 SPINAL SPHERES INTERBODY INNOVATIONS LLP J D WEBB
K071587 07/30/2007 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY INVERNESS MEDICAL INNOVATIONS, INC. JAMES DELANEY
K071251 07/26/2007 DEMI KERR CORPORATION COLLEEN BOSWELL
K071599 07/11/2007 EASYGUIDE KEYSTONE DENTAL, INC. MARTIN J LEIGHTON
K070183 07/13/2007 KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K070767 07/24/2007 EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION LAPIS LAZULI INTERNATIONAL NV MARTIN DALSING
K071542 07/05/2007 DIGITAL STEREOLOC II LORAD, A HOLOGIC CO. GAIL YAEKER-DAUNIS
K070392 07/13/2007 MOSAIC LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K063427 07/25/2007 LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM LYNTON LASERS LIMITED ANDREW JOHN BERRY
K071088 07/05/2007 LIFE LATCH SHARPS & BIOHAZARD CONTAINER M&M INDUSTRIES, INC. NORMAN F ESTRIN
K062377 07/03/2007 MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 MEDAPPS, INC. KENT E DICKS
K070112 07/13/2007 RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM MEDCOOL INC MAUREEN O'CONNELL
K070794 07/10/2007 ATLANTIK MEDICAL BIOMAT AURELIEN BIGNON
K071870 07/08/2007 HEXAPOD RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K063063 07/03/2007 SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION MEDICAL MOLECULAR THERAPUETICS LLC ARTHUR B FLICK
K063069 07/13/2007 SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION MEDICAL MOLECULAR THERAPUETICS LLC ARTHUR B FLICK
K070730 07/03/2007 FLEX-NECK ARC CATHETER MEDIGROUP, INC. JOHN A NAVIS
K071423 07/18/2007 MEDLINE LATEX FOLEY CATHETER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K070577 07/13/2007 ON THE GO SHARPS MEDPORT, INC. FRAN WHITE
K070175 07/25/2007 AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K071253 07/03/2007 AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 MEDTRONIC VASCULAR JESSICA SIXBERRY
K070598 07/26/2007 MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE MEMOMETAL TECHNOLOGIES GILLES AUDIC
K070877 07/27/2007 ENDOCERVICAL ELECTRODE # 2 MODERN MEDICAL EQUIPMENT MFG., LTD. BOB STILLMAN
K062436 07/30/2007 SIS SINUS IMPLANT STABILIZER MONDEAL MEDICAL SYSTEMS GMBH ANGELIKA SCHERP
K071354 07/13/2007 MEPILEX AG DRESSING MONLYCKE HEALTH CARE STEVEN DOWDLEY
K071819 07/26/2007 NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 NCONTACT SURGICAL, INC. JANE RICUPERO
K063710 07/16/2007 SATURN 9000 NEW MEDICAL CO., LTD. YOUNG-HOON SHIN
K071639 07/09/2007 QWIX POSITIONING SCREW NEWDEAL SAS JUDITH E O'GRADY
K071147 07/20/2007 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM NEXA ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K070500 07/16/2007 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM NI MEDICAL JAMES COLLIE
K071182 07/11/2007 PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 NOBEL BIOCARE AB PHUONG NGUYEN SON
K070611 07/11/2007 BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 NOMOS CORP. MARITA BRUST
K071285 07/12/2007 DIGITAL PULSE OXIMETER, MODEL 7500 NONIN MEDICAL, INC. LORI M ROTH
K070960 07/11/2007 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K071191 07/23/2007 NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT NOVARTIS NUTRITION CORP.
K063355 07/27/2007 D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW NOVOSCI CORP. DAVID MAKANANI
K063805 07/13/2007 SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 NUCRYST PHARMACEUTICALS, INC. STEVEN J CHARTIER
K070148 07/31/2007 GRAFT CONTAINMENT DEVICE NUVASIVE, INC. LAETITIA COUSIN
K070377 07/11/2007 GIRAFFE AND PANDA WARMER OHMEDA MEDICAL AGATA SMIEJA
K070983 07/05/2007 OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K071645 07/02/2007 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S OMRON HEALTHCARE, INC. PAUL DRYDEN
K071673 07/18/2007 ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 ONC SOLUTIONS, INC. JOHN SCHWAMB
K071801 07/20/2007 VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA
K070132 07/13/2007 TRIPORE, MODELS HA, BP90, BP15 ORTHOGEM LIMITED ROD RUSTON
K070555 07/13/2007 ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES ORTHOPRO LLC CHRISTOPHER COOK
K071714 07/20/2007 NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K061934 07/17/2007 XTAC OSTEOGENICS, INC. MICHAEL DEUTSCH
K071105 07/30/2007 OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM OSTEOMED L.P. DAWN D TINDALL
K070298 07/03/2007 MODIFICATION TO PALOMAR LUXIR HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE
K070973 07/03/2007 QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K070731 07/31/2007 PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K062118 07/13/2007 POINTE 360 POINTE SCIENTIFIC, INC. RON JAMISON
K071342 07/31/2007 ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 POSSIS MEDICAL, INC. MARK STENOIEN
K071514 07/31/2007 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 POSSIS MEDICAL, INC. FRANK B FREEDMAN
K070516 07/02/2007 POWERLASER POWERMEDIC APS ARNE GRINSTED
K070846 07/02/2007 MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM PROSURG, INC. ASHVIN DESAI
K070737 07/25/2007 XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES PROSURG, INC. ASHVIN DESAI
K070766 07/26/2007 PSI BANDS PSI HEALTH SOLUTIONS, INC. ROMY TAORMINA
K071322 07/13/2007 POWDER FREE LATEX EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH B HOON
K070805 07/11/2007 ULTRAWAVE II EX 1320 QUANTA SYSTEM, S.P.A. JONATHAN S KAHAN
K071590 07/31/2007 THERMA-CURE RELIANCE ORTHODONTIC PRODUCTS, INC. PAUL GANGE
K070746 07/13/2007 RESTRAXX DATA CENTRE, MODEL R10 RESMED LTD. DAVID D'CRUZ
K071171 07/10/2007 VPAP AUTO WITH H3I RESMED LTD. DAVID D'CRUZ
K071212 07/30/2007 ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARA CALER
K071113 07/05/2007 RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K071786 07/26/2007 PORTRAIT PSR RHYTEC INCORPORATED ROBERT ZOLETTI
K071292 07/19/2007 VIEW MD OFFICE SYSTEM, MODEL 41066.5540 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K071211 07/30/2007 COBAS C 111 ANALYZER ROCHE DIAGNOSTICS CORINA HARPER
K070709 07/13/2007 ROCHE ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY TAYLOR
K070915 07/06/2007 SAPIMED DISPOSABLE SIGMOIDOSCOPE SAPIMED S.P.A. E J SMITH
K071155 07/03/2007 MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER SCIENCE FOR BIOMATERIALS DENIS CLEMENT
K071060 07/26/2007 NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) SGMP CO., LTD. JANNA P TUCKER
K071847 07/23/2007 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD SONGTAO ZHANG
K071882 07/18/2007 MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD SONGTAO ZHANG
K063757 07/27/2007 MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD. KE-MIN JEN
K063641 07/13/2007 PC-60, NON-INVASIVEPULSE OXIMETER SHENZHEN CREATIVE INDUSTRY CO., LTD MACK CHARLES
K070852 07/13/2007 VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR SHIJIAZHANG HONGXIANG PLASTIC PRODUCTS CO., LTD. KATHY LIU
K071717 07/05/2007 GE OEC ALTITUDE SHIMADZU CORP. AKIRA SHIGEYASU
K071452 07/09/2007 FL BOND II SHOFU DENTAL CORP. DAVID MORAIS
K071950 07/27/2007 SYNGO TRUED SIEMENS MEDICAL SOLUTIONS USA, INC. JAMES KUHN
K071698 07/06/2007 AURORA LED SERIES SURGICAL LIGHTS SKYTRON, DIV. THE KMW GROUP, INC. LARRY PEREZ
K071300 07/20/2007 MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE SMITH & NEPHEW, INC. KATHY REDDIG
K070732 07/09/2007 BCI AUTOCON 3304 DIGITAL PULSE OXIMETER SMITHS MEDICAL PM, INC. DONALD ALEXANDER
K071629 07/10/2007 PARIETEX POLYESTER MESH WITH INTRODUCER SOFRADIM PRODUCTION RENEE BORGESANO
K071556 07/18/2007 SOMNOSCREEN EEG10-20 SOMNOMEDICS GMBH CHERITA JAMES
K062584 07/05/2007 PRESSIO ICP MONITORING SYSTEM SOPHYSA SA ESTHER SALTZ
K071318 07/06/2007 MODIFICATION TO: STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON
K071156 07/03/2007 SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER SOUNMED, INC. JHOANA LORES
K070634 07/11/2007 SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 SOYEE PRODUCT, INC. STEPHEN T MLCOCH
K071227 07/11/2007 CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 SPECTRANETICS CORP. MICHAEL K HANDLEY
K071725 07/11/2007 M2 MONITOR SPECTRUM MEDICAL LTD STEVE TURNER
K061914 07/26/2007 SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS SPORT-ELEC S.A. ARMELLE LAPRELLE
K070743 07/02/2007 Z6 STIMULATOR ST CARDIO TECHNOLOGIES, LLC BILL ABBOUD
K070461 07/17/2007 VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 STERIS CORPORATION JOHN SCOVILLE
K071585 07/11/2007 P.004 HEALING ABUTMENTS AND CLOSURE SCREWS STRAUMANN USA ELAINE ALAN
K070882 07/20/2007 STRYKER PEEK TWINLOOP TAC STRYKER ENDOSCOPY JEFF SEMONE
K070631 07/13/2007 DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM STRYKER SPINE SIMONA VOIC
K071473 07/12/2007 MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 SUPERDIMENSION, LTD. CLAY ANSELMO
K071571 07/30/2007 SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM SURGIQUEST, INC. KOUROSH AZARBARZIN
K071728 07/13/2007 MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC. LINDA OLESON
K071288 07/19/2007 MODIFICATION TO KAVO QUATTROCARE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K071735 07/19/2007 MODIFICATION TO DISPOSABLE INFUSION PUMP KIT SYMBIOS MEDICAL PRODUCTS, LLC MICHAEL JAMES
K070092 07/27/2007 MODIFICATION TO VELASMOOTH, SHAPER SYNERON MEDICAL LTD. YONI IGER
K071503 07/26/2007 SYSTEM, TOMOGRAPHY, COMPUTED EMISSION SYNTERMED, INC. KENNETH F VAN TRAIN
K071264 07/09/2007 SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE SYNTHES (USA) DEBORAH L JACKSON
K063275 07/27/2007 DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) TERRAY CORP. STEVEN WILLIS
K071572 07/23/2007 CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER TERUMO CORP. GARRY A COURTNEY
K071494 07/16/2007 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER TERUMO CORP. GARY COURTNEY
K071630 07/11/2007 TERUMO 31G THINPRO INSULIN SYRINGE TERUMO MEDICAL CORP. EILEEN DORSEY
K071743 07/06/2007 PILLAR PEDICLE SCREW SYSTEM THE 4TH COLUMN, LLC DAVID J COLLETTE
K071031 07/30/2007 VU E*POD VERTEBRAL BODY REPLACEMENT THEKEN SPINE LLC DALE DAVISON
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