FDA 510(k) Decisions During July, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K111316 07/20/2011 AAP CANNULATED SCREWS AAP IMPLANTATE AG MARC SEEGERS
K111417 07/15/2011 THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K111110 07/22/2011 APNEA GUARD ADVANCED BRAIN MONITORING, INC. PAUL DRYDEN
K111194 07/07/2011 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K101114 07/26/2011 ADVANCIS ACTIVON TUBE Advancis Medical Toni Miller
K111076 07/12/2011 SOLANAS AVALON POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K111864 07/15/2011 E-CUBE 9 ALPINION MEDICAL SYSTEMS CO., LTD YUCHI CHU
K111034 07/14/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA KAREN THOMISON
K111118 07/01/2011 AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS MONA INMAN
K110328 07/15/2011 ACG-8511 PORTABLE ECG MONITOR ANDON HEALTH CO.,LTD LIU YI
K093755 07/15/2011 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K111750 07/21/2011 EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K111531 07/08/2011 RHA2020 ANNIDIS HEALTH SYSTEMS CORP. MICHAEL MCDONNELL
K103714 07/07/2011 ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA ANSELL HEALTHCARE PRODUCTS, LLC MARY L ARMSTRONG
K111856 07/14/2011 SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE APOTHECARY PRODUCTS, INC. JAMES JENKINS
K110824 07/11/2011 ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT ARAGON SURGICAL INC. ALAN CURTIS
K110994 07/06/2011 PARKER 500 ARJOHUNTLEIGH INC BRENDA AMMONETTE
K111399 07/20/2011 SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 ARTHROCARE CORP. LAURA KASPEROWICZ
K111397 07/12/2011 TITAN TI SUTURE ANCHOR SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K110189 07/18/2011 REPROCESSED ELECTROSURGICAL INSTRUMENT ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K111851 07/08/2011 MEDIOSTAR NEXT ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K111215 07/05/2011 ASCOM MOBILE MONITORING GATEWAY (MMG) ASCOM (SWEDEN) AB TANIA OTTEBRINK
K102643 07/15/2011 SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. JASON C REYNOLDS
K102719 07/01/2011 ATLANTEAN TRIGGER NEBULIZER ATLANTEAN CORPORATION TOM SHANKS
K110842 07/13/2011 ATLAS SPINE PEDICLE SCREW SYSTEM ATLAS SPINE INC. JEANNETTE G DAILEY
K110696 07/07/2011 NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. EDWARD SINCLAIR
K110443 07/19/2011 BD INSYTE AUTOGUARD BC BECTON DICKINSON & CO. RAND PUGMIRE
K110703 07/27/2011 BD AUTOSHIELD DUO PEN NEEDLE Becton, Dickinson and Company CYNTHIA LACATENA
K103685 07/15/2011 PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. Diana Hong
K103631 07/21/2011 SLEEPMINDER BREATHING FREQUENCY INDICATOR BIANCAMED LIMITED PAUL PHILLIPS
K110778 07/29/2011 BIODENTA CUSTOMIZED ABUTMENT BIODENTA SWISS AG ANGELA BLACKWELL
K102051 07/29/2011 PAIN BUDDY BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K110320 07/21/2011 COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K110271 07/22/2011 MAESTRO WRIST PLATING SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K110201 07/21/2011 EXPLOR RADIAL HEAD PLATING SYSTEM BIOMET, INC. PATRICIA S BERES
K102405 07/21/2011 INFUSION SET FOR POWERPICC SOLO 2 CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K111850 07/13/2011 VACCESS PTA DILATATION CATHETER C.R. BARD, INC. CANDACE WADE
K111144 07/18/2011 CANDELA GENTLELASE FAMILY OF LASERS CANDELA CORP. SCOTT BLOOD
K094048 07/14/2011 PERCUPRO MESSENGER BALLOON CATHETER CARDIOSOLUTIONS INC MICHELE LUCEY
K111388 07/26/2011 DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. MEGAN M BRANDT
K110809 07/05/2011 WIRELESS MONITORING SYSTEM CAREFUSION 303, INC. SIMON PEARMAIN
K101194 07/11/2011 NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 CARTICEPT MEDICAL INC Tanya Eberle
K110682 07/01/2011 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K111348 07/22/2011 RE / STASIS (TM) GINGIVAL RETRACTION PASTE CENTRIX, INC. JOHN DISCKO
K110600 07/29/2011 COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN COLLAGEN MATRIX, INC. PEGGY HANSEN
K111619 07/06/2011 MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K110156 07/27/2011 AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K111263 07/25/2011 CXI TRIFORCE COOK INCORPORATED MOLLY BUSENBARK
K103431 07/21/2011 COREN TOTAL HIP SYSTEM CORENTEC CO., LTD KEVIN A THOMAS
K111187 07/26/2011 PATCH, PLEDGET AND INTRACARDIAC CORMATRIX CARDIOVASCULAR, INC. KIT CARIQUITAN
K094026 07/12/2011 STERI-DENT, STERI-SURE CPAC, INC. JEFFREY CRANE
K110867 07/20/2011 STERI-DENT, STERI-SURE CPAC, INC. JEFFREY S CRANE
K110529 07/22/2011 ENDOFLIP GASTRIC TUBE CROSPON, LTD. PAUL DRYDEN
K111774 07/20/2011 PATHWAY MODEL 07XXXX CUSTOM SPINE SAAD ATTIYAH
K110213 07/20/2011 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. JIM RASKOB
K103220 07/29/2011 VOYAGER PERITONEAL DIALYSIS SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. ROGER A LEROUX
K103831 07/21/2011 DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K111631 07/22/2011 GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K111077 07/12/2011 ORTHOSORB RESORBABLE PINS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K110546 07/27/2011 MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY DERMA SCIENCES, INC. RONALD S WARREN
K110869 07/14/2011 CARA DIAGNOS, INC Aron Shapiro
K111362 07/21/2011 REXIOUS SPINAL FIXATION SYSTEM DIO MEDICAL CO., LTD. APRIL LEE
K103285 07/25/2011 DIXTAL DZ-4100 SERIES PULSE OXIMETER DIXTAL MEDICAL, INC. ROBERT H SCHIFFMAN
K110439 07/18/2011 DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. CURTIS JENSEN
K110577 07/14/2011 OSSEOFUSE DENTAL IMPLANT SYSTEM DYNAMIC INNOVATIONS INC. APRIL LEE
K110922 07/20/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K110915 07/22/2011 CERVICAL CAGE EISERTECH, LLC LUKAS EISERMANN
K101997 07/12/2011 ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K111009 07/22/2011 ACRYLIC HERBST APPLIANCE EMBASSY DENTAL LABORATORY KAREN E WARDEN, PHD
K111061 07/20/2011 REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) ENCORE MEDICAL, L.P. TEFFANY HUTTO
K111821 07/28/2011 BIOPSY VALVE ENDOCHOICE, INC. THERON GOBER
K111747 07/12/2011 ENDOLOGIX AFX INTRODUCER SYSTEM ENDOLOGIX, INC. Janet M Fauls
K111803 07/15/2011 G-SCAN ESAOTE, S.P.A. Allison Scott
K111302 07/22/2011 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. Allison Scott
K110197 07/15/2011 EXACTECH GIBRALT SPINAL SYSTEM EXACTECH, INC. VLADISLAVA ZAITSEVA
K111400 07/28/2011 OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT EXACTECH, INC. PATRICK HUGHES
K110541 07/06/2011 FIGURE 8 STERNOTOMY CLOSURE DEVICE FIGURE 8 SURGICAL, INCORPORATED KIT CARIQUITAN
K110797 07/20/2011 COMMUNIFY PACS VIEWER FLYING SQUIRREL STORAGE LLC CHRIS RELYEA
K110044 07/07/2011 FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM FORA CARE INC. TELING HSU
K101306 07/01/2011 SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A FOTONA D.D. STOJAN TROST
K103676 07/19/2011 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL FUJIREBIO DIAGNOSTICS, INC. DIANA LYN DICKSON
K103129 07/19/2011 ENTROPY EASYFIT SENSOR GE HEALTHCARE JOEL KENT
K111209 07/26/2011 INTEGRATED INNOVA - S5I SYSTEM OPTION GE HEALTHCARE FAYCAL KHERRA
K110943 07/22/2011 LOGIQ E9 GE HEALTHCARE BRYAN BEHN
K111582 07/26/2011 LOGIQ S8 GE HEALTHCARE BRYAN BEHN
K110227 07/20/2011 OPTIMA CT660 GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
K111304 07/19/2011 OPTIMA XR120 GE MEDICAL SYSTEMS, LLC NIDHI CHAUDHARY
K103671 07/21/2011 GENESYS SPINE TILOCK SYSTEM GENESYS SPINE BRIAN J BERGERON
K103745 07/20/2011 BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) WENDY A MCMANUS
K110280 07/06/2011 REVLOK FENESTRATED SCREW SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K110990 07/25/2011 GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM GOLD STANDARD ORTHOPEDICS LLC JAMES RITTER
K111326 07/06/2011 OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM GRAHAM MEDICAL TECHNOLOGIES, L.L.C. JULIE POWELL
K111560 07/15/2011 WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K111328 07/15/2011 POWDER FREE NITRILE EXAMINATION GLOVES GX CORPORATION SDN BHD GANESAN SUPIRAMUNIAM
K110852 07/19/2011 DOLPHIN 3 FLUID MANAGEMENT SYSTEM GYRUS ACMI, INC. GRAHAM BAILLIE
K110390 07/29/2011 ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR HANDELSHAUS DITTMAN GMBH KANG JIANG PING
K111065 07/14/2011 STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS CALUDIA WIESEMANN
K100305 07/21/2011 ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER ICOTEC BARBARA ATZENHOEFER STEGMEIER
K101407 07/19/2011 ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN, PH.D
K102286 07/20/2011 CRAG LATERAL FLOW ASSAY (CRAG LFA) IMMUNO-MYCOLOGICS, INC. SEAN BAUMAN
K103130 07/28/2011 XELIS 3D INFINITT CO., LTD. CARL ALLETTO
K102528 07/28/2011 N-FORCE FIXATION SYSTEM INNOVISION, INC. MICHELLE MCDONOUGH
K111529 07/29/2011 MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- INSERT MOLDING SOLUTIONS, INC PAUL HENDRIXSON
K110237 07/08/2011 HEMOSIL FACTOR VIII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. Jacqueline Emery
K101381 07/07/2011 HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS INTEGRA LIFESCIENCES CORPORATION DONNA MILLISKY
K110987 07/22/2011 CARDIAC TRIGGER MONITOR IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K103830 07/29/2011 JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) JIANGSU SHENLI MEDICAL PRODUCTION FACTORY DARREN REEVES
K111571 07/06/2011 VIPER SYSTEMS JOHNSON & JOHNSON DAPHNEY GERMAIN-KOLAWOLE
K110548 07/29/2011 OSI O-BALL ABUTMENT HEAD IMPLANTS JUELL DENTAL ANGELA BLACKWELL
K111280 07/21/2011 V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT KCI USA, INC. MARGARET MARSH
K110960 07/14/2011 ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE KOON SENG SDN.BHD Kevin Walls
K103414 07/22/2011 VENUS CERVICAL SPINAL FIXATION SYSTEM L&K BIOMED CO.,LTD. SUN YI LEE
K110984 07/22/2011 SLIM E30 II CO2 LASER LASERING S.R.L. ALLEN R HOWES
K103574 07/28/2011 PREGNANCY ONE STEP RAPID TEST Lehnus & Associates Consulting Gary Lehnus
K111884 07/29/2011 OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K111569 07/06/2011 PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K111835 07/19/2011 PLATEAU SPACER SYSTEM LIFE SPINE, INC RANDY LEWIS
K110847 07/15/2011 SMR SHOULDER SYSTEM - CTA HUMERAL HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K111212 07/28/2011 SMR SHOULDER SYSTEM- REVISION STEMS LIMACORPORATE S.P.A. CHERYL HASTINGS
K110298 07/15/2011 OPIATE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. BERNICE LIN
K111598 07/20/2011 POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE LPL (HUI ZHOU) GLOVE CO., LTD. CAMILLE D THORNTON
K111213 07/25/2011 VISION ONE LASER SYSTEM LUMENIS INC. JACE R MCLANE
K103776 07/01/2011 XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K110880 07/05/2011 VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT MAINE STANDARDS COMPANY, LLC HOLLY CRESSMAN
K111524 07/22/2011 MP 719 MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K110723 07/28/2011 M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS MASIMO CORPORATION SHELLY HARRIS
K110300 07/01/2011 SIMPLANT 2011 MATERIALISE DENTAL NV PETER VANDEPUT
K093548 07/20/2011 AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K101089 07/13/2011 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR MEDICA CORP. Photios Makris
K111036 07/12/2011 EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT MEDICA CORPORATION Photios Makris
K111601 07/08/2011 HERO MEDICAL PREDICTIVE SCIENCE CORP. WILL KING
K110956 07/18/2011 MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR MEDIVANCE, INC. LYNNE ARONSON
K111147 07/19/2011 MEDLINE VESSEL CANNULA MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K111424 07/29/2011 VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH MEDPRO SAFETY PRODUCTS, INC. Judi Smith
K111972 07/27/2011 AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF MEDTRONIC INC. JESSICA SIXBERRY
K103731 07/18/2011 CAPSTONE R SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK THAO PHAN
K103077 07/13/2011 ECG PEN MERIDIAN DYNAMICS BIOMEDICAL, INC JENNIFER REICH
K111611 07/29/2011 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT MERIT MEDICAL SYSTEMS, INC. JOHN C KNORPP
K110643 07/01/2011 MERIT MARQUIS FLOW SWITCH MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K111536 07/21/2011 METASURG DIGIFUSE IMPLANT METASURG JOSHUA SCOTT
K111652 07/13/2011 MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K111259 07/05/2011 SV DBS VRAIN ARRAY MIDWEST RF, LLC HELMUT KEIDI
K111906 07/29/2011 XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY NAVILYST MEDICAL, INC. Lorraine M Hanley
K102815 07/07/2011 SURELIFT PROLAPSE SYSTEM NEOMEDIC INTERNATIONAL JEFFREY R SHIDEMAN
K110285 07/14/2011 NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER NEPHROS, INC. JAMES SUMMERTON
K111493 07/27/2011 NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI NIDEK CO., LTD. MICHAEL J BILLIG
K110376 07/29/2011 PE-210AK SWITCH BOX NIHON KOHDEN CORP. STEVE GEERDES
K110925 07/05/2011 NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K111866 07/22/2011 NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM NUVASIVE, INC. Sheila Bruschi
K101453 07/21/2011 VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE OBI BIOLOGICS, INC. DUSTYN WEBB
K111062 07/13/2011 APEX KNEE SYSTEM, APEX ALL POLY TIBIA OMNILIFE SCIENCE INC. CHRISTINE NASSIF
K111045 07/15/2011 CENTRO FAMILY OF MANUAL WHEELCHAIRS OTTO BOCK HEALTHCARE, LP WILLIAM KABITZ
K111000 07/28/2011 PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR PARCUS MEDICAL, LLC BARTON BRACY
K111380 07/19/2011 NEURON MAX SYSTEM PENUMBRA, INC. MICHAELA MAHL
K111517 07/27/2011 PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI PHARMAJET, INC. MICHAEL J RYAN
K111804 07/28/2011 INTELLISPACE PACS 4.X PHILIPS HEALTHCARE INFORMATICS, INC. VICTORIA S MACKINNON
K111245 07/29/2011 HEARTNAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K110608 07/20/2011 SEVOFLURANE VAPORIZER ADAPTOR PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) JAMIE KELLER
K111031 07/08/2011 PAINFUSOR CATHETER PLAN 1 HEALTH, S.R.L. SIGI CARON
K110970 07/21/2011 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K110966 07/21/2011 POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K103563 07/01/2011 PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 PRECISION MEDICAL, INC. JAMES PARKER
K111291 07/20/2011 AIDITE ZIRCONIA DENTAL CERAMICS QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD STUART R GOLDMAN
K111555 07/25/2011 CIRCUMAURAL ADHESIVE REPLACEMENT R & D MEDICAL PRODUCTS, INC. JAMES PERRAULT
K111897 07/19/2011 ABL90 RADIOMETER MEDICAL APS Martin Gabler
K111222 07/28/2011 MRI-Q SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY LTD GREG HOLLAND
K111226 07/01/2011 ENDOSCOUT TRACKING SYSTEM ROBIN MEDICAL, INC. RAYMOND KELLY
K111506 07/08/2011 ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics Sarah Baumann
K111552 07/21/2011 ELECSYS T3 CALCHECK 5 Roche Diagnostics KELLY FRENCH
K110897 07/01/2011 CORTEX CO2 / ER:YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K111725 07/19/2011 MOBILEDIAGNOST WDR SEDECAL SA JENNIFER CARTLEDGE
K111312 07/13/2011 SANTEVIEW SEHYUN CO., LTD. Priscilla Chung
K111752 07/27/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG JIANHONG NEW MATERIAL COMPANY CHU XIAOAN
K110981 07/12/2011 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG YINGHONG MEDICAL PRODUCTS CO., LTD. FRANK LIU
K110857 07/15/2011 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR SHANDONG ZHANPENG MEDICAL PRODUCTS CO., LTD FRANK LIU
K102648 07/01/2011 ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD LYNN FU
K110928 07/15/2011 BODY ANALYSIS SCALE, MODEL BG 17 SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD CHARLIE MACK
K111435 07/08/2011 DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN
K111596 07/05/2011 TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC ANDREW RODENHOUSE
K111205 07/20/2011 MICROSCAN (R) MICROSTREP PLUS (R) PANELS SIEMENS HEALTHCARE DIAGNOSTICS, INC. SHANNON POPSON
K111179 07/01/2011 ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN SIESTA MEDICAL, INC. MICHAEL KOLBER
K101886 07/21/2011 DSC/ALF SPINAL SYSTEM SINTEA PLASTEK, LLC DANIELLE WERNIKOWSKI
K111025 07/01/2011 TRIGEN LOW PROFILE BONE SCREW SMITH & NEPHEW, INC. NATALIE P WILLIAMS
K110670 07/12/2011 VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES SMITH & NEPHEW, INC. DAVID HENLEY
K110261 07/28/2011 ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS SOFLEX LIMITED Kevin Walls
K103740 07/29/2011 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE SPECTRA MEDICAL DEVICES, INC. DAVID L ROSEN, B.S. PHARM., J.D.
K110507 07/13/2011 CARDIAC SCANNER AND PROCESSING SYSTEM SPECTRUM DYNAMICS (ISRAEL) LTD. ILAN SHARON
K111469 07/19/2011 STAXXSD SYSTEM SPINE WAVE, INC. DENISE DUCHENE
K110906 07/26/2011 APEX SPINE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
K111006 07/21/2011 CI-SNAP WOUND CARE SYSTEM SPIRACUR, INC. SARAH CANIO
K111393 07/28/2011 SNAP (R) WOUND CARE SYSTEM SPIRACUR, INC. SARAH CANIO
K111002 07/18/2011 REPROCESSED ENDOSCOPIC TROCARS STERILMED, INC. GARRETT AHLBORG
K111870 07/29/2011 AMSCO WARMING CABINET STERIS Corporation ROBERT F SULLIVAN
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