FDA 510(k) Applications Received During October, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K113197 10/31/2011 APC FLASH-FREE ADHESIVE 3M UNITEK CORPORATION ROBERT WANG
K112852 10/18/2011 BABI PLUS NEONATAL RESUSCITATION BAG A PLUS MEDICAL THOMAS C LOESCHER
K113151 10/25/2011 IFS LASER SYSTEM ABBOTT MEDICAL OPTICS INC KESLEY E GALLAGHER
K112957 10/05/2011 HI-TORQUE POWERTURN ABBOTT VASCULAR-CARDIAC THERAPIES KAY SETZER
K113162 10/26/2011 SLIDEWIRETM(TRADEMARK PENDING) ACME-MONACO CORP. BENJAMIN SWEENEY
K113063 10/14/2011 CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD JOHN J SMITH
K112977 10/06/2011 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) ALCON RESEARCH, LTD. CATHERINE GOBLE
K113124 10/21/2011 ALN OPTIONAL VANA CAVA FILTER ALN IMPLANTS CHIRURGICAUX CYNTHIA COTTEREAU
K113046 10/13/2011 AMEDITECH IMMUTEST MILTI-DRUG SCREEN AMEDITECH, INC. GREG CERRA
K113011 10/19/2011 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICH JANSEN
K113098 10/19/2011 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K112331 10/25/2011 BIOPURE PORTABLE RO SYSTEMS ARION WATER, INC. ROBERT LIVINGSTION
K113110 10/20/2011 AXERA ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K112990 10/06/2011 ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE ARTHREX, INC. CHRISTINA FLORES
K112899 10/03/2011 ARTHREX BIO-SUTURE ARTHREX, INC. SALLY FOUST
K112979 10/12/2011 ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K113003 10/07/2011 ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... ASTRA TECH INC. BETSY A BROWN
K113165 10/26/2011 MINI-MEDIC ATHENA GTX SEAN MAHONEY
K113112 10/20/2011 CLEARWAY RX NB CATHETER ATRIUM MEDICAL CORP. MEGAN MCCAGH
K113059 10/14/2011 CONTIPLEX FX B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K112909 10/03/2011 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION BAUSCH & LOMB, INC. TRICIA GARRETT
K113073 10/17/2011 IO-TOME DEVICE BAXANO, INC. EDWARD J SINCLAIR
K112893 10/03/2011 CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K112933 10/03/2011 ACCESS THYROGLOBULIN ANITBODY BECKMAN COULTER, INC. GERALDINE L BAGLIEN
K112911 10/03/2011 FETAL DOPPLER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K113018 10/11/2011 APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM BEIJING SYNTECH LASER CO., LTD. DIANA HONG
K113065 10/19/2011 RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS BELLA ELEVATOR, LLC RICK CRANE
K112639 10/25/2011 THE BELMONT BUDDY LITE FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K112934 10/03/2011 NEUROTECH RECOVERY BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K112987 10/06/2011 TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARY HAYES
K113069 10/17/2011 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY BIOMET MANUFACTURING CORP. PATRICIA S BERES
K113121 10/21/2011 COMPREHENSIVE REVERSE SHOULDER BIOMET MANUFACTURING, INC. PATRICIA S BERES
K112905 10/03/2011 COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM BIOMET ORTHOPEDICS LLC. GARY BAKER
K113007 10/07/2011 BIONIME DIABETES MANAGEMENT SYSTEM VI.0 BIONIME CORPORATION FENG-YU LEE
K112994 10/07/2011 CRE DITATATION BALLON BOSTON SCIENTIFIC CORPORATION JANIS TARANTO
K113101 10/19/2011 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL BOSTON SCIENTIFIC CORPORATION SUSAN EICHLER-HUSTON
K113090 10/19/2011 LEVEEN SUPERSLIM NEEDLE ELECTRODE BOSTON SCIENTIFIC CORPORATION ASHLEY PYLE
K113119 10/21/2011 ENDOGATOR ADVANTAGE IRRIGATION PUMP BYRNE MEDICAL, INC. BRENT GEIGER
DEN110004 10/31/2011 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN BRIAN
K113176 10/28/2011 MYSENSE HEART CARDIAC SCIENCE CORPORATION NEIL SHELLER
K112918 10/03/2011 DURABLUE STERILIZATION (AMSCO V-PRO) WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K113096 10/19/2011 MICRO I CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K112904 10/04/2011 STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K112985 10/06/2011 CATHETER CONNECTIONS' DUALCAP DUO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K112960 10/05/2011 LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K113168 10/27/2011 DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC CIBA VISION CORPORATION ALICIA M PLESNARSKI
K113132 10/24/2011 DISPOSABLE HEMOSTATIC Y-CONNECTORS COEUR, INC. DEBRA F MANNING
K113058 10/14/2011 TIGER SPINE SYSTEM CORELINK LLC JUSTIN EGGLETON
K113060 10/14/2011 UNITY TOATAL KNEE SYSTEM CORIN U.S.A. LUCINDA GERBER
K113187 10/31/2011 AVIVO MOBILE PATIENT MANAGEMENT CORVENTIS, INC. KATHLEEN LUNDBERG
K113021 10/11/2011 TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT CSA MEDICAL, INC. COLLEEN KISTLER
K112974 10/05/2011 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM CURVE DENTAL, INC. GEORGE STANTCHEV
K113106 10/20/2011 DNE EXTERNAL FIXATION SYSTEM D.N.E., LLC J.D. WEBB
K113152 10/25/2011 ULTRASONIC SURGERY MACHINE DMETEC CO., LTD. DANIEL NAM
K113040 10/12/2011 CERAMIR CROWN & BRIDGE DOXA DENTAL AB MARGARETH JORVID
K113095 10/19/2011 E-CARE INFRARED EAR THERMOMETER E-CARE TECHNOLOGY CORPORATION KIN-YUAN KO
K112992 10/11/2011 EARLOGIC OAE TESTER EARLOGIC CORPORATION SHIN KUK YOO
K113050 10/13/2011 CLEARPATH LOWER GI EASYGLIDE LTD. PAUL DRYDEN
K113166 10/27/2011 CLEARPATH UPPER GI EASYGLIDE LTD. PAUL DRYDEN
K113170 10/27/2011 CERVICAL PLATE EISERTECH, LLC LUKAS EISERMANN
K112937 10/03/2011 MRSA/SA ELITE MGB ELITECH DEBRA K HUTSON
K113062 10/14/2011 ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES ENDOSERVICE OPTICAL INSTRUMENTS GMBH ANDREA PECSI
K112901 10/03/2011 EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K113205 10/31/2011 ARTISYN Y-SHAPED MESH ETHICON, INC. SARAH MCMANUS
K113004 10/07/2011 PDS(TM) BARBED SUTURES ETHICON, INC. PETER CECCHINI
K112996 10/07/2011 EUROIMMUN ANTI-ENA POOL ELISA (IGG) EUROIMMUN US KATHRYN KOHL
K113010 10/11/2011 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR FAMIDOC TECHNOLOGY CO., LTD CAO LIANG
K113202 10/31/2011 TISSUE MARKER FOCAL THERAPEUTICS GEORGE HERMANN
K112944 10/04/2011 FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. RAM KAMATH
K112700 10/06/2011 FRONTIER SADL INTERBODY FUSION DEVICE FRONTIER MEDICAL DEVICES, INC. RICH JANSEN
K113034 10/11/2011 GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM GE HEALTHCARE CAROL ALLOIAN
K113107 10/20/2011 MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K112976 10/11/2011 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM HARTALEGA SND. BHD. NURUL A KONG
K113129 10/24/2011 SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) HEIDELBERG ENGINEERING GMBH GERHARD ZINSER
K113054 10/13/2011 EQUIVITAL HIDALGO LIMITED EKTA SOOD
K112910 10/03/2011 AP 72OS SEMI-AUTOMATED INSTRUMENT HITACHI CHEMICAL DIAGNOSTICS, INC. DONALD POSTEL
K113145 10/25/2011 ECHELON OVAL MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K113020 10/21/2011 IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K113143 10/25/2011 IMMULISA SCI-70 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K113192 10/31/2011 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K113088 10/19/2011 HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) INNERSPACE, INC DON BOBO
K113111 10/20/2011 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION INOVO, INC. MICHAEL T DILDINE
K112945 10/04/2011 ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM INRAD INC. RYAN GOOSEN
K112995 10/07/2011 GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO. CARL MARBLE
K113211 10/31/2011 HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL INSTRUMENTATION LABORATORY CO. JACQUELINE EMERY
K113104 10/20/2011 INTEGRA WOUND MATRIX (THIN) INTEGRA LIFESCIENCES CORPORATION STEPHEN H BEIER
K112986 10/06/2011 LATERAL FUSION DEVICE INTEGRA SPINE (INTEGRA LIFESCIENCES) DALE DAVISON
K112950 10/04/2011 JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD JEN KE-MIN
K112948 10/04/2011 JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD JEN KE-MIN
K113091 10/19/2011 SYRINGES AND NEEDLES JIANGYIN CAINA TECHNOLOGY CO., LTD DIANA HONG
K112913 10/03/2011 SPOTLIGHT ACCESS SYSTEM JOHNSON & JOHNSON LAURA BLEYENDAAL
K113138 10/25/2011 ALEUTIAN SYSTEM K2M, INC. NANCY GIEZEN
K112920 10/03/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K113056 10/14/2011 ORANGE COLORED CONDOMS ORANGE SCENT KAREX INDUSTRIES SDN BHD LAI PENG LIM
K113061 10/14/2011 LARGE/EXTRA LAGRE CONDOM KAREX INDUSTRIES SDN BHD. LAI PENG
K113199 10/31/2011 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT KEVO MEDICAL SUPPLIES E.J. SMITH
K113036 10/12/2011 U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORPORATION LORI BARR
K113157 10/26/2011 AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE RANDY LEWIS
K113115 10/21/2011 EPICARE YAG LIGHT AGE, INC. ELIZABETH REDDINGTON
K112898 10/03/2011 DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS LIMACORPORATE S.P.A. CHERYL HASTINGS
K112900 10/03/2011 SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K113139 10/24/2011 LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K112965 10/05/2011 NANO SUTURE ANCHOR LINVATEC CORPORATION D/B/A CONMED LINVATEC ASHLEA RICCI
K113100 10/19/2011 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS MAXTER GLOVE MANUFACTURING SDN BHD YAP P GEEH
K113080 10/18/2011 TUBALGATOR MECTRA LABS, INC. CHARLES E ALLGOOD
K113074 10/17/2011 CMAP PRO MEDICAL TECHNOLOGIES, INC. ANGELA MORRIS
K112921 10/03/2011 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM MEDICAL.GORITHMICS S.A. MARTIN JASINSKI
K112736 10/11/2011 PASS LP SPINAL MEDICREA INTERNATIONAL J D WEBB
K113028 10/11/2011 MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS MEDISISS JOYCE ELKINS
K112907 10/03/2011 CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G MEDOS INTERNATIONAL SARL ROBIN DINARDO
K113133 10/24/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE MEDRAD, INC. MIKE BURNSIDE
K113174 10/27/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K112917 10/03/2011 ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID MEDTRONIC, INC. DEBORAH KIDDER
K113190 10/31/2011 TRU LEGIONELLA MERIDIAN BIOSCIENCE, INC. SUSAN BOGAR
K112789 10/11/2011 EASY TOUCH MHC MEDICAL PRODUCTS, LLC DANIEL KAMM
K113128 10/24/2011 MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE SURGICAL INSTRUMENTS, LLC DARREN REEVES
K113015 10/11/2011 ALDAHOL V HIGH LEVEL DISINFECTANT MICROCHEM LABORATORIES, INC. NORMAN MINER
K113141 10/24/2011 MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K112930 10/03/2011 MOBILE MIM MIM SOFTWARE INC. LYNN HANIGAN
K113167 10/27/2011 MTF NEW BONE VOILD FILLER MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY JOY
K113173 10/27/2011 NANOVIS SPINAL SYSTEM NANOVIS, LLC KAREN E WARDEN PHD.
K113198 10/31/2011 NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML NAVILYST MEDICAL, INC. MARION W GORDON
K113033 10/12/2011 SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML NEPHRON PHARMACEUTICALS CORP. MARCUS JULIANO
K113117 10/21/2011 NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX NIHON KOHDEN AMERICA, INC. STEVE GEERDES
K112969 10/05/2011 AIR-BAG SYSTEM NIIGATA MECHATRONICS CO., LTD. TOSHIYA NIMONJI
K112988 10/06/2011 POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE NORTHSTAR HEALTHCARE HOLDINGS LIMITED ANTONIO L GIACCIO
K112955 10/04/2011 NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K113102 10/19/2011 ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING NUCLETRON MICHEAL PAUL
K113023 10/11/2011 STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K113066 10/17/2011 CORVIS ST OCULUS OPTIKGERATE GMBH ECKHARD LOH
K113120 10/21/2011 CHF-Y0005 OLYMPUS MEDICAL SYSTEMS CORP. SHERI MUSGNUNG
K113185 10/28/2011 MODEL HBP-1300 OMRON HEALTHCARE, INC. PAUL DRYDEN
K113048 10/12/2011 MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K113006 10/07/2011 I-FUSE HAMMER TOE SYSTEMS ORTHOPRO LLC J D WEBB
K112952 10/05/2011 ILWAIT TIMER OCULOPRESSOR ORYX MEDICAL PTY LTD ANNE F JONES
K113113 10/20/2011 ENDOSSEOUS DENTAL IMPLANT OT MEDICAL GMBH SABINE SCHMAHL
K113164 10/26/2011 DISCOVERY TMAX MANUAL WHEELCHAIR OTTO BOCK HEALTHCARE, LP WILLIAM KABITZ
K113209 10/31/2011 CHIBA SONO PAJUNK GMBH CHRISTIAN QUASS
K113207 10/31/2011 SONO TAP, TUOHY SONO PAJUNK GMBH CHRISTIAN QUASS
K113188 10/31/2011 SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYING"SONO"/SONOLONG" PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K113196 10/31/2011 VASCULAR SONO PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K113037 10/12/2011 PAIN-AID PDI WORKS, LLC. THU-HA DUNCAN
K113163 10/26/2011 PENUMBRA SYSTEM MAX PENUMBRA, INC. SETH SCHULMAN
K113082 10/18/2011 SONOVISION PERIDOT TECHNOLOGIES NY INC OMAR BARLAS
K112959 10/04/2011 CALG-STR EXERCISE ECG ANALYSIS ALGORITHM PHILIPS HEALTHCARE GRETEL LUMLEY
K113125 10/24/2011 INTELLIVUE MX40 PATIENT MONITOR PHILIPS MEDICAL SYSTEMS THERESA POOLE
K113144 10/25/2011 PAGEWRITER TC 20, 30, 50, 70 PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K112931 10/03/2011 LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM PHYGEN, LLC HARTMUT LOCH
K113076 10/17/2011 CAAS A-VALVE PIE MEDICAL IMAGING B.V. FLORIE DANIELS
K113122 10/21/2011 PIPELINE CR PRIMARY KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K112967 10/05/2011 PMMA CAD/CAM DISC POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY JANJA LIPUSCEK
K113070 10/17/2011 PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. JAFAR SHENASA
K112946 10/06/2011 ACTIV VARNISH PULPDENT CORPORATION KENNETH J BERK
K113177 10/28/2011 COMPLETE D 25-OH VITAMIN D CONTROL QUANTIMETRIX CORP. KALYNA SNYLYK
K113105 10/20/2011 TEMPUSIC PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD. CHRIS HANNAN
K113084 10/18/2011 RENOVIS CANNULATED SCREW SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC DAVID F ROTHKOPF
K112897 10/03/2011 RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS RENOVIS SURGICAL TECHNOLOGIES, LLC DAVID A TEICHER
K113127 10/24/2011 MIRAGE QUATTRO RESMED LTD. DAVID D'CRUZ
K112914 10/03/2011 VPAP TX RESMED LTD. DAVID D'CRUZ
K113201 10/31/2011 NARVAL CC RESMED SAS DAVID D'CRUZ
K113053 10/13/2011 BIPAP A 30 VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ELAINE LARKIN
K113068 10/17/2011 REMSTAR AUTO A-FLEX HT RESPIRONICS, INC. FRANK KADI
K113103 10/19/2011 SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE REX MEDICAL SUSAN D GOLDSTEIN-FALK
K112936 10/03/2011 SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA SANDRA ANDERSON
K113042 10/12/2011 REVOIS IMPLANT SYSTEM RIEMSER ARZNEIMITTEL AG JAMES M CLINTON
K112924 10/03/2011 RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K112928 10/18/2011 RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K113072 10/17/2011 TINA-QUANT ALBUMIN GEN.2 ROCHE DIAGNOSTICS OPERATIONS PATRICK STIMART
K112991 10/06/2011 MODIFIED ROG SUTURE ANCHOR ROG SPORTS MEDICINE, INC. CURTIS RAYMOND
K113146 10/27/2011 PCXX VARNISH ROSS HEALTHCARE INC. MARC N ROSS
K112961 10/04/2011 CLO-SURPLUS P.A.D. SCION CARDIO-VASCULAR, INC. CRAIG PAGAN
K112840 10/17/2011 CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR SEEBREATH AB ANETTE SJOGREN
K113183 10/28/2011 PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 SHANGHAI 3F ELECTRONICS CO LTD CHARILIE MACK
K112951 10/04/2011 BODY ANALYSIS SCALE SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD CHARLIE MACK
K113153 10/25/2011 DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN
K113186 10/28/2011 STERILE INSULIN PEN NEEDLE SHINA CORP. JISEOP JEONG
K112999 10/24/2011 DIMENSION CLINICAL CHEMISTRY SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS LORRAINE H PIESTRAK
K113027 10/11/2011 SYNGO AORTIC VALVEGUIDE SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K113029 10/20/2011 SYNGO VIA MI WORKFLOWS SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K113179 10/28/2011 ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI ROBERT F LAWRENCE
K112997 10/07/2011 HD-IVUS ULTRASOUND IMAGING SYSTEM SILICON VALLY MEDICAL INSTRUMENTS, INC. RICHARD E ANDERSON
K113008 10/07/2011 KODAMA INTRAVASCULAR ULRASOUND CATHETER SILICON VALLY MEDICAL INSTRUMENTS, INC. RICHARD E ANDERSON
K113022 10/11/2011 PURESLEEP SLEEP SCIENCE PARTNERS, INC. HEATHER FLICK
K112982 10/06/2011 ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) SMALL BONE INNOVATIONS INC. JOHN MINIER
K112941 10/04/2011 LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS SMITH & NEPHEW, INC. DAVID HENLEY
K113012 10/11/2011 PROMOS MODULAR SHOULDER SYSTEM SMITH & NEPHEW, INC. MEGAN BEVILL
K113038 10/12/2011 SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS SMITH & NEPHEW, INC. GINO ROUSS
K113039 10/12/2011 SMITH & NEPHEW RADIOPAQUE TRIAL NECKS SMITH & NEPHEW, INC. NATALIE P WILLIAMS
K113156 10/26/2011 SONOSITE EDGE ULTRASOUND SYSTEM SONOSITE,INC. SCOTT PAULSON
K113203 10/31/2011 SONY LMD-2451MT LCD MONITOR SONY ELECTRONICS, INC. CYNTHIA SINCLAIR
K113051 10/13/2011 SPACELABS ARKON ANESTHESIA WORKSTATION SPACELABS HEALTHCARE THOMAS KROENKE
K112962 10/05/2011 SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) SPACELABS MEDICAL INC. DAVVID J GERAGHTY
K113030 10/12/2011 SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE SPINEOLOGY, INC. BRYAN BECKER
K113032 10/12/2011 SNAP WOUND CARE SYSTEM SPIRACUR, INC. SARAH CANIO
K112915 10/03/2011 SPIRTIUS CUFF INFLATION SYRINGE SPIRITUS TECHNOLOGIES LLC BRANDON W CLOSE
K113049 10/13/2011 SOCKET GRAFT STEINER LABORATORIES GREGORY G STEINER
K113109 10/25/2011 STRYKER RESORBABLE FIXATION SYSTEM STRYKER MANISH PATEL
K112926 10/03/2011 AXSOS LOCKING PLATE SYSTEM STRYKER CORP. KELLY KUCHARCZYK
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