FDA 510(k) Applications Received During June, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K111759 06/22/2011 .DECIMAL ELECTRON APERTURE .DECIMAL, INC. DANIEL L BENNETT
K111686 06/16/2011 A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS A&D COMPANY, LTD. JERRY WANG
K111697 06/17/2011 AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC OPHELIA BIGGS
K111617 06/10/2011 PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 ACARE TECHNOLOGY CO., LTD. Diana Hong
K111608 06/09/2011 SLIC SCREW REPAIR SYSTEM ACUMED LLC HOLLACE RHODES
K111805 06/27/2011 ECG SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K111518 06/02/2011 STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111519 06/02/2011 STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111638 06/13/2011 IMPAX VOLUME VIEWING AGFA HEALTHCARE N.V. KOEN COBBAERT
K111587 06/07/2011 ALERKAN SPIROMETRY FILTER ALERKAN LTD Glen Feye
K111634 06/13/2011 XENON(TM) PEDICLE SCREW SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K111864 06/30/2011 E-CUBE 9 ALPINION MEDICAL SYSTEMS CO., LTD YUCHI CHU
K111680 06/15/2011 DR. GREENSBURG'S HYBRID ALWAYS MORE MARKETING INC JONATHAN GREENBURG
K111740 06/21/2011 AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION AMERIWATER BRIAN R BOWMAN
K111830 06/28/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO ANDON HEALTH CO., LTD LIU YI
K111826 06/28/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K111750 06/22/2011 EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K111531 06/02/2011 RHA2020 ANNIDIS HEALTH SYSTEMS CORP. MICHAEL MCDONNELL
K111532 06/03/2011 MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE ANTHOGYR SAS BRAYETTE SABINE
K111549 06/03/2011 ATTUNE SLEEP APNEA SYSTEM APNICURE, INC. CHRIS DANIEL
K111856 06/29/2011 SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE APOTHECARY PRODUCTS, INC. JAMES JENKINS
K111661 06/14/2011 ARTHREX SCAPHOLUNATE ANCHOR ARTHREX, INC. COURTNEY SMITH
K111799 06/27/2011 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM ASCENSION ORTHOPEDIC BRADLEY W STRASSER
K111600 06/08/2011 REPROCESSED HAND ACTIVATE SEALER/DIVIDER ASCENT HEALTHCARE SOLUTIONS RAMONA KULIK
K111851 06/29/2011 MEDIOSTAR NEXT ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K111828 06/28/2011 CLEARSPLINT ES ASTRON DENTAL CORPORATION DOUGLAS S MULLER
K111547 06/03/2011 BILI-THERAPY PAD TYPE ATOM MEDICAL CORPORATION PAUL DRYDEN
K111704 06/17/2011 AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX AVINGER, INC. SEVRINA CIUCCI, RAC
K111662 06/14/2011 VENOTRAIN CURAFLOW BAUERFEIND AG INES EXNER
K111523 06/01/2011 OSTEOCOOL (TM) RF ABLATION SYSTEM BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K111860 06/30/2011 BD MAX GBS ASSAY, BD MAX INSTRUMENT BECTON DICKINSON & CO. MARY ANNE WILLIAMS
K111831 06/28/2011 MX-7000 MICROXEL BIO-MED U.S.A., INC. YOUNG CHI
K111809 06/27/2011 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC. Kevin Walls
K111599 06/08/2011 VITEK 2 AST-ST LINEZOLID BIOMERIEUX, INC. NATHAN HARDESTY
K111564 06/06/2011 MAXFIRE MARXMEN MENISCAL REPAIR DEVICE BIOMET SPORTS MEDICINE ELIZABETH WRAY
K111746 06/21/2011 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET, INC. PATRICIA SANDBORN BERES
K111839 06/29/2011 SELECTRA ACCESSORY KIT BIOTRONIK, INC. Jon Brumbaugh
K111593 06/07/2011 GUARDIAN INFLATABLE BONE EXPANDER SYSTEM BM KOREA CO., LTD. RONALD D ARKIN
K111820 06/28/2011 SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE BM KOREA CO., LTD. Priscilla Chung
K111609 06/09/2011 BOSTON BAND BOSTON BRACE INTL., INC. JAMES WYNNE
K111648 06/13/2011 BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K111850 06/29/2011 VACCESS PTA DILATATION CATHETER C.R. BARD, INC. CANDACE WADE
K111694 06/16/2011 ASTRA CANDELIS, INC. VINCENT CIPOLLA
K111612 06/09/2011 DIGITAL RETINAL CAMERA CANON, INC. KOJI KUBO
K111682 06/15/2011 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K111824 06/28/2011 FLAT PANEL DETECTOR CANON, INC.-MEDICAL EQUIPMENT GROUP DIANE RUTHERFORD
K111710 06/20/2011 FULL AUTO TONOMETER MODEL TX-20 CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K111745 06/21/2011 KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANSELMO
K111649 06/13/2011 CS 7600 CARESTREAM HEALTH, INC. DANIEL HOEFER
K111566 06/06/2011 DRYVIEW CHROMA IMAGING SYSTEM CARESTREAM HEALTH,INC. CHRISTINE EHAMNN
K111507 06/01/2011 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CAPT HYE-JOO KIM, PHARM.D.
K111690 06/16/2011 DEVINE SPINAL SYSTEM CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. Diana Hong
K111841 06/29/2011 SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD XINGLONG TIAN
K111619 06/10/2011 MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K111779 06/24/2011 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 CONMED LINVATEC JOHN CUSACK
K111695 06/16/2011 HYBRID GRAFT COOK BIOTECH, INC. MARY A FADERAN, PHD, RAC
K111716 06/20/2011 KNOTLESS SUTURE FIXATION SYSTEM CORE ESSENCE ORTHOPAEDICS JEFF MILLER
K111578 06/07/2011 CORELEADER COLLA-ALGI FIBER MODEL CAW CORELEADER BIOTECH CO., LTD. IAN LI
K111733 06/21/2011 CORELEADER SCAR-DIMMER CORELEADER BIOTECH CO., LTD. IAN LI
K111817 06/27/2011 PALINDROME RT CHRONIC CATHETER COVIDIEN WING NG
K111825 06/28/2011 ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H FRANK GIANELLI
K111774 06/23/2011 PATHWAY MODEL 07XXXX CUSTOM SPINE SAAD ATTIYAH
K111726 06/20/2011 PATHWAY AVID CUSTOM SPINE, INC. DAVID DRUMFIELD
K111542 06/02/2011 DELTEX MEDICAL CARDIOQ EDM DELTEX MEDICAL LIMITED NEIL R ARMSTRONG
K111689 06/16/2011 STLASE DENTAL PHOTONICS, INC Marcy Moore
K111631 06/13/2011 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
K111663 06/14/2011 TRAUMA INTERNAL FIXATION SYSTEMS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K111589 06/07/2011 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG DERMA CARE PLUS PRODUCTS, LLC JOSEPH NEUSER
K111833 06/28/2011 VIRTUE DIAGNOSOFT, INC. JEFFREY ROBERTS
K111822 06/28/2011 STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH DIAGNOSTICA STAGO, INC. CARLO D'ALESSANDRO
K111534 06/02/2011 ABACUS 3CP DIATRON US INC MICHAEL SWITZER
K111664 06/14/2011 DIAZYME CYSTATIN C POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K111758 06/22/2011 CADENS (TM) COLON DOG MICROSYSTEMS, INC. FLORENT CHANDELIER
K111583 06/07/2011 FLAATZ 560 DRTECH CORP. CHOUL-WOO SHIN
K111655 06/13/2011 FLAATZ 760 DRTECH CORP. CHOUL-WOO SHIN
K111808 06/27/2011 SONOLITH I-MOVE EDAP TMS FRANCE HOLSTEIN HOWARD
K111705 06/17/2011 EKOSONIC ENDOVASCULAR SYSTEM EKOS CORPORATION JOCELYN KERSTEN
K111717 06/20/2011 ELECTRO-GEL ELECTRO-CAP INTL., INC. AMY B SWALLOWS
K111676 06/15/2011 APEX Elekta Limited Patrick Hull
K111730 06/20/2011 SONOTT FLOWLAB(R) EM-TEC GMBH BERNHARD BRAND
K111742 06/21/2011 MDRIVE EMBLA SYSTEMS ROBERT G SCHUEPPERT
K111735 06/21/2011 REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER ENCORE MEDICAL, L.P. TEFFANY HUTTO
K111629 06/13/2011 TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K111821 06/28/2011 BIOPSY VALVE ENDOCHOICE, INC. THERON GOBER
K111747 06/22/2011 ENDOLOGIX AFX INTRODUCER SYSTEM ENDOLOGIX, INC. Janet M Fauls
K111763 06/23/2011 PATHASSIST LIGHT FIBER Entellus Medical, Inc. KAREN E PETERSON
K111603 06/08/2011 LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM EP DYNAMICS, INC. ALBERT REGO
K111728 06/20/2011 EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. YC LEI
K111527 06/01/2011 MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT ERAGEN BIOSCIENCES, INC. DAVID LIM
K111803 06/27/2011 G-SCAN ESAOTE, S.P.A. Allison Scott
K111845 06/29/2011 THE ESPINER SAC OR E SAC ESPINER MEDICAL LIMITED EDWIN LINDSAY
K111541 06/02/2011 ENDO-EXPRESS (R) HANDPIECE ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K111751 06/22/2011 VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, INC. BRIAN A KANERVIKO
K111723 06/20/2011 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC BRENDA JOHNSON
K111535 06/02/2011 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K111702 06/17/2011 AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC. Kim Forch
K111683 06/15/2011 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. SHOSHANA FRIEDMAN
K111720 06/20/2011 AVIAFIT FLOWMEDIC LTD. AHAVA STEIN
K111639 06/13/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE DENISE OPPERMANN
K111703 06/17/2011 INFRARED EAR THEROMETER FUDAKANG INDUSTRIAL CO LTD DANIEL NAM
K111645 06/13/2011 FD TENS 2050 OR SLIDE TENS MODEL FD2050 FUJI DYNAMICS LTD CHING KONG (FELIX) LEE
K111654 06/13/2011 FD TENS 2070 FUJI DYNAMICS LTD CHING KONG (FELIX) LEE
K111646 06/13/2011 ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K111865 06/30/2011 WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K111548 06/03/2011 WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K111859 06/30/2011 ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL INC. AMY MCKINNEY
K111791 06/27/2011 LUMAGEM MOLECULAR BREAST IMAGING SYSTEM GAMMA MEDICA-IDEAS INCORPORATED Albert Boniske
K111731 06/20/2011 MOLECULAR BREAST IMAGING SOFTWARE GAMMA MEDICA-IDEAS INCORPORATED Albert Boniske
K111582 06/06/2011 LOGIQ S8 GE HEALTHCARE BRYAN BEHN
K111614 06/08/2011 CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE GE HEALTHCARE INTEGRATED IT SOLUTIONS JEME WALLACE
K111551 06/03/2011 OEC(R) 9800, OEC(R) 9800 PLUS GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K111644 06/13/2011 MOBICATH TRANSSEPTAL NEEDLE Greatbatch Medical Kristi Fox
K111560 06/03/2011 WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K111636 06/13/2011 REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM GUNNELL, INC. ANDREW EVANCHO
K111573 06/06/2011 MONOBLOC BM SERIES HASS CORP. Priscilla Chung
K111832 06/28/2011 PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K111753 06/22/2011 HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA B AMMIRATI, RAC, MT (ASCP)
K111508 06/01/2011 TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 HOLOGIC, INC. DEBORAH THOMAS
K111766 06/23/2011 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS IDEV TECHNOLOGIES, INC. DARENE GARNER
K111627 06/10/2011 SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K111650 06/13/2011 IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K111660 06/14/2011 XELIS CARDIAC INFINITT CO., LTD. CARL ALLETTO
K111613 06/09/2011 XELIS FUSION INFINITT CO., LTD. CARL ALLETTO
K111857 06/30/2011 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE INMED GLOVES FACTORY XIAOBING LI
K111647 06/13/2011 C2 NERVEMONITOR SYSTEM WITH ACCESSORIES INOMED MEDIZINTECHNIK GMBH SASCHKA BUSCH
K111529 06/02/2011 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
K111669 06/15/2011 FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS INSULET CORPORATION SUSAN FINNERAN
K111741 06/21/2011 INTEGRA(TM) CUSA NXT(TM) BONE TIPS INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI KEVIN J O'CONNELL
K111673 06/15/2011 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL INVIVO CORPORATION ELIZABETH WHEELER
K111838 06/29/2011 INQU PASTE MIX ISTO TECHNOLOGIES, INC. PATSY J TRISLER
K111743 06/21/2011 THE INSYNC CERAMIC SYSTEM JENSEN INDUSTRIES, INC. GARY PHELPS
K111571 06/06/2011 VIPER SYSTEMS JOHNSON & JOHNSON DAPHNEY GERMAIN-KOLAWOLE
K111748 06/22/2011 RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A JOY LONG JOY LONG
K111772 06/23/2011 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE KOSSAN LATEX INDUSTRIES(M)SDN BHD CHO SOW FONG
K111837 06/29/2011 RADIAL ARTERY COMPRESSION TOURNIQUET LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD SHAN ZHAO
K111714 06/20/2011 HAIRMAX DUAL 12 LEXINGTON INTERNATIONAL, LLC CASPER E ULDRICKS ESQ.
K111569 06/06/2011 PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K111729 06/20/2011 PILOT SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K111835 06/29/2011 PLATEAU SPACER SYSTEM LIFE SPINE, INC RANDY LEWIS
K111516 06/01/2011 NMR LIPOPROFILE (R) TEST AND NMR PROFILER LIPOSCIENCE, INC SUZETTE M WARNER
K111598 06/08/2011 POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE LPL (HUI ZHOU) GLOVE CO., LTD. CAMILLE D THORNTON
K111816 06/27/2011 EQUIMATRIX LUITPOLD PHARMACEUTICALS, INC. MARSHA SIMON
K111524 06/02/2011 MP 719 MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K111621 06/10/2011 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS MASIMO CORPORATION ANIL BHALANI
K111863 06/30/2011 SIGNATURE PLANNER,SIGNATURE GUIDES MATERIALISE N.V. ALAXANDRA RAZZHIVINA
K111558 06/03/2011 SURGICASE GUIDE MATERIALISE N.V. Alexandra Razzhivina
K111641 06/13/2011 SURGICASE ORTHOGNATHIC SOFTWARE WIZARD MATERIALISE N.V. OLIVER CLEMENS
K111785 06/24/2011 FREEDOM(R) STEMMED TIBIAL COMPONENTS MAXX ORTHOPEDICS, INC. NACHE DAVE
K111651 06/13/2011 SPLIT CATH III MEDICAL COMPONENTS INC JEAN CALLOW
K111601 06/08/2011 HERO MEDICAL PREDICTIVE SCIENCE CORP. WILL KING
K111734 06/21/2011 MYSAFETY SYRINGE MEDICALCHAIN INTL. CORP. ROBIN HWANG
K111807 06/27/2011 MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K111577 06/07/2011 MEDLINE VIAL DECANTER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K111658 06/14/2011 AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. LISA STONE
K111525 06/01/2011 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK MIKE SCOTT
K111510 06/01/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. KEVIN FORD
K111520 06/02/2011 IPC POWEREASE SYSTEM MEDTRONIC XOMED, INC. RISHI SINHA
K111657 06/14/2011 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE MEDTRONIC, INC. LISA STONE
K111611 06/09/2011 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT MERIT MEDICAL SYSTEMS, INC. JOHN C KNORPP
K111536 06/02/2011 METASURG DIGIFUSE IMPLANT METASURG JOSHUA SCOTT
K111652 06/13/2011 MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K111802 06/27/2011 SV BRAIN ARRAY, SIEMENS 3T MRI INTERVENTIONS, INC. E.F. WADDELL
K111588 06/07/2011 LEGACY-500 MT TABLES, LLC MILBURN TENNIS
K111687 06/16/2011 EMG SYSTEM MYOTRONICS-NOROMED, INC. F. ADIB
K111618 06/10/2011 AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION NATUS MEDICAL INCORPORATED CHARLES L MORIN
K111668 06/14/2011 CAVIOS CAVITY LINER NEO DENTAL CHEMICAL PRODUCTS CO., LTD. ROBERT SEIPLE
K111666 06/14/2011 EVADYNE TEMPORARY CROWN AND BRIDGE RESIN NEO DENTAL CHEMICAL PRODUCTS CO., LTD. ROBERT SEIPLE
K111761 06/23/2011 NEO TITANIUM MESH, CTI-MEM NEOBIOTECH CO., LTD. RON ARKIN
K111767 06/23/2011 NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS MONICA STACHURA,JD
K111576 06/06/2011 NT 2000 LESIONING GENERATOR NEUROTHERM, INC. F. DAVID ROTHKOPF
K111581 06/07/2011 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE NOBEL BIOCARE AB HERBERT CRANE
K111811 06/27/2011 BENDINI(TM) SPINAL ROD BENDING SYSTEM NUVASIVE, INC. Elias Ketchum
K111597 06/08/2011 DISPOSABLE STIMULATING ELECTRODE NUVASIVE, INC. Sheila Bruschi
K111866 06/30/2011 NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM NUVASIVE, INC. Sheila Bruschi
K111788 06/24/2011 ENDOEYE HD II OLYMPUS AMERICA, INC. STACY ABBATIELLO KLUESNER
K111756 06/22/2011 V1 SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. STACY ABBATIELLO KLUESNER
K111643 06/13/2011 OPTO MITRA YELLOW LASER OPTO ELECTRONICA SA PAULO ANEAS LICHTI
K111628 06/10/2011 P200T OPTOS PLC HOWARD M HOLSTEIN
K111678 06/15/2011 ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K111575 06/06/2011 HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX ORTHOCON, INC. ROSEMARY HARRY
K111672 06/15/2011 MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER PACIFIC HOSPITAL SUPPLY CO., LTD IRENE LIN
K111840 06/29/2011 EMERGE FRACTIONAL LASER PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K111517 06/02/2011 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 06/27/2011 INTELLISPACE PACS 4.X PHILIPS HEALTHCARE INFORMATICS, INC. VICTORIA S MACKINNON
K111693 06/16/2011 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K111513 06/01/2011 CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. PENNY GRECO
K111632 06/13/2011 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC REBECCA K SPINE
K111528 06/02/2011 PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K111684 06/15/2011 PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD PLAYTEX MANUFACTURING INC. PUSHPA RAO
K111739 06/21/2011 KIDS ROCK 3 CHAIR PRIDE MOBILITY PRODUCTS CORP. KIMBERLY BLAKE
K111765 06/23/2011 FULL CORE BIOPSY SYSTEM PROMEX TECHNOLOGIES, LLC Allison Scott
K111522 06/02/2011 CHARTIS CATHETER MODEL CHR-CA-12.0 PULMONX, INC. HANS SCHULZ
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K111681 06/15/2011 HISTOBRUSH PURITAN MEDICAL PRODUCTS COMPANY LLC WILLIAM M YOUNG
K111592 06/07/2011 YOULASER CO2 LASER SYSTEM QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K111555 06/03/2011 CIRCUMAURAL ADHESIVE REPLACEMENT R & D MEDICAL PRODUCTS, INC. JAMES PERRAULT
K111637 06/13/2011 INFRARED EAR THERMOMETER RADIANT INNOVATION, INC. LYNN CHEN
K111814 06/27/2011 PADLOCK RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K111773 06/23/2011 RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE RENU MEDICAL, INC. L BRUCE PIERSON
K111610 06/09/2011 TRILOGY SERIES VENTILATOR WITH OXIMETRY RESPIRONICS, INC. JOSEPH E OLSAVSKY
K111776 06/23/2011 DELTAVIEW MODEL 2.1 RIVERAIN MEDICAL GROUP,LLC JENNIFER V BUTSCH
K111506 06/01/2011 ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics Sarah Baumann
K111552 06/03/2011 ELECSYS T3 CALCHECK 5 Roche Diagnostics KELLY FRENCH
K111590 06/07/2011 ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR ROG SPORTS MEDICINE, INC. CURTIS RAYMOND
K111616 06/10/2011 E-CUBE SAESHIN PRECISION CO., LTD. Y S LEE
K111732 06/20/2011 AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER SALIENT SURGICAL TECHNOLOGIES, INC. MARTIN J LEIGHTON
K111737 06/21/2011 DISPOSABLE ELECTRODE SANIBEL SUPPLY ERIK NIELSEN
K111858 06/30/2011 LIFTKAR PT SANO TRANSPORTGERAETE GMBH JEANINE A CARROCCIO
K111623 06/10/2011 I-ENDO DUAL SATELEC-ACTEON GROUP RICK ROSATI
K111671 06/15/2011 SEASPINE MONOPOLAR PROBE SYSYEM SEASPINE, INC. DAN MILLER
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K111572 06/06/2011 NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL SERF J.D. WEBB
K111557 06/03/2011 X-FORCE SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC MARK IOELE
K111752 06/22/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG JIANHONG NEW MATERIAL COMPANY CHU XIAOAN
K111559 06/06/2011 SURGICAL MASKS SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. Diana Hong
K111855 06/29/2011 HY-BOND RESIGLASS SHOFU DENTAL CORP. DAVID P MORAIS
K111782 06/24/2011 BEAUTISEALANT SHOFU DENTAL CORPORATION DAVID P MORAIS
K111685 06/16/2011 IP TEMP CEMENT SHOFU DENTAL CORPORATION DAVID P MORAIS
K111596 06/08/2011 TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC ANDREW RODENHOUSE
K111677 06/15/2011 MICROSCAN(R) MICROSTREP PLUS(R) SIEMENS HEALTHCARE DIAGNOSTICS, INC. JENIFER DAWSON DRISCOLL
K111674 06/15/2011 ACUSON SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
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K111792 06/27/2011 MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI SIGNUS MEDIZINTECHNIK GMBH KAREN E WARDEN, PHD
K111620 06/10/2011 SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS SKELETAL DYNAMICS, LLC ANA M ESCAGEDO
K111538 06/02/2011 SKAFFOLD CIS SKELETAL KINETICS, LLC CHRISTINE KUO
K111514 06/01/2011 SBV2, MULTICHARGER MODEL MC10V2 SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE MARC GOODMAN
K111760 06/22/2011 NAVIAID(TM) BGC DEVICE SMART MEDICAL SYSTEMS, LTD. ADVA YOSELZON
K111843 06/29/2011 ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM SMITH & NEPHEW INC., ENDOSCOPY DIV. JANICE HASELTON
K111711 06/20/2011 JOURNEY II BCS KNEE SYSTEM SMITH & NEPHEW, INC. SHEREEN MYERS
K111635 06/13/2011 SMITH & NEPHEW RJ CONSTRAINED LINERS SMITH & NEPHEW, INC. MEGAN BEVILL
K111692 06/16/2011 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC SOMATEX MEDICAL TECHNOLOGIES GMBH HARALD JUNG
K111550 06/03/2011 SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) SONOMA ORTHOPEDIC PRODUCTS, INC. CHARLES L NELSON
K111553 06/03/2011 SPINEFRONTIER LUMBAR IBF SYSTEM SPINEFRONTIER, INC. HANNAH CROWE
K111515 06/01/2011 SPSMEDICAL SPORVIEW STEAM BI SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K111854 06/29/2011 AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER ST. JUDE MEDICAL SYSTEMS AB MIKAEL SJOLANDER
K111794 06/27/2011 REPROCESSED HARMONIC SCALPEL STERILMED, INC. ONYA DENDINGER
K111810 06/27/2011 AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS STERIS Corporation ROBERT SULLIVAN
K111798 06/27/2011 STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... STERNGOLD DENTAL LLC. MARIA RAO
K111724 06/20/2011 STRAUMANN TIBRUSH STRAUMANN USA ELAINE ALAN
K111848 06/29/2011 EXETER X3 RIMFIT ACETABULAR CUP STRYKER CORP. ESTELA CELI
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K111509 06/01/2011 SWEETSPOT DIABETES DATA MANAGEMENT SERVICE SWEETSPOT DIABETES CARE, INC. CHRIS LOGAN
K111540 06/02/2011 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM SYNTHES (USA) THOMAS N SHEA
K111667 06/14/2011 SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS SYNTHES (USA) CHRISTOPHER HACK
K111595 06/07/2011 NEUMOVENT GRAPHNET TECME S.A. Ray Kelly
K111797 06/24/2011 27 G X 1/2 K-PACK SURSHIELD NEEDLE TERUMO EUROPE N.V. M.J. AERTS
K111556 06/06/2011 GLIDECROSS SUPPORT CATHETER TERUMO MEDICAL CORP. MARK UNTERREINER
K111606 06/09/2011 PINNACLE PRECISION ACCESS SYSTEM TERUMO MEDICAL CORP. DANIEL R PLONSKI
K111570 06/06/2011 MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR THAYER MEDICAL CORPORATION ERIKA S STRICKLAND
K111675 06/15/2011 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC DALE DAVISON
K111512 06/01/2011 BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM THOMPSON MIS INC FRANK SULLIVAN
K111626 06/10/2011 ENDOSKELETON(R) TAS TITAN SPINE, LLC RICH JANSEN
K111633 06/13/2011 AQUILION LB MOVEMENT BASE KIT TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K111762 06/23/2011 ST AIA-PACK DHEA-S CALIBRATOR SET Tosoh BioScience, Inc. JUDITH K OGDEN
K111642 06/13/2011 ONCO TRAC MODEL 1, 2, 4 TRANSLATIONAL SCIENCES CORPORATION ALLEN GREEN, MD, PHD, JD
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K111834 06/29/2011 DISCO SUBTALAR IMPLANT TRILLIANT SURGICAL LTD J D WEBB
K111544 06/03/2011 GLIDER PTCA BALLOON CATHETER TRIREME MEDICAL INC SHIVA ARDAKANI
K111738 06/21/2011 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) TRIREME MEDICAL, INC. SHIVA ARDAKAMI
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K111778 06/23/2011 JBAIDS INFLUENZA A SUBTYPING KIT U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY PATRICIA M BEVERLY
K111604 06/08/2011 LANO-E UG GLOBAL RESOURCES SDN BHD KENNETH STANTON
K111718 06/20/2011 LANO-E UG GLOBAL RESOURCES SDN BHD KENNETH STANTON
K111696 06/17/2011 OPAL BAND CEMENT ULTRADENT PRODUCTS, INC. DIANE ROGERS
K111836 06/29/2011 PERMASHADE VENEER CEMENT ULTRADENT PRODUCTS, INC. COREY JASEPH
K111818 06/28/2011 SONIXGPS NEEDLE SENSOR UltraSonix Medical Corporation CHAS YU
K111622 06/10/2011 UNIMAX ANTI-FOG SOLUTION UNIMAX MEDICAL SYSTEMS, INC. MICHAEL LEE
K111715 06/20/2011 EMBRYOSCOPE UNISENSE FERTILITECH A/S METTE MUNCH
K111771 06/23/2011 NON-CONTACT TEAR FILM THERMOGRAGH UNITED INTEGRATED SERVICES CO., LTD. JEN KE-MIN
K111546 06/03/2011 U2 HIP SYSTEM UNITED ORTHOPEDIC CORP. FANG-YUAN HO
K111709 06/20/2011 FOUNDATION DENTAL RESIN UNIX-JAPAN CO., LTD. TOSHIKO BOYD
K111640 06/13/2011 PRECISION FLOW(R) - HELIOX VAPOTHERM, INC. GREGORY A WHITNEY
K111543 06/02/2011 VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) VENTANA MEDICAL SYSTEMS, INC. INDU LAKSHMAN
K111755 06/22/2011 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) VENTANA MEDICAL SYSTEMS, INC. TROY QUANDER
K111670 06/15/2011 VENUS FREEZE (MP)2 SYSTEM VENUS CONCEPT LTD YORAM LEVY
K111784 06/21/2011 VENUS SWAN SYSTEM VENUS CONCEPT LTD YORAM LEVY
K111862 06/30/2011 VIEWRAY SYSTEM VIEWRAY INCORPORATED JANICE BROWNLEE
K111706 06/17/2011 VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM VOLCANO CORPORATION JWALA JAWHARKAR
K111521 06/01/2011 WAVES WATERS MEDICAL SYSTEMS, LLC ROBERT WARREN
K111781 06/24/2011 GYMFORM DUAL FLEX BELT MODEL WB-162 WELL BRAIN INTERNATIONAL, LTD. VICTOR K WAI
K111698 06/17/2011 PROFEMUR(R) E CEMENTLESS HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. GREGORY NEAL
K111699 06/17/2011 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. GREGORY NEAL
K111584 06/07/2011 XYLOS MACRO-POROUS SURGICAL MESH XYLOS CORPORATION GONZALO C SERAFICA
K111853 06/29/2011 ANGLED TAPERED ABUTMENT ZIMMER DENTAL INC. MELISSA BURBAGE
K111852 06/29/2011 ANODIZED HEALING COLLAR ZIMMER DENTAL INC. MELISSA BURBAGE
K111796 06/27/2011 INVIZIA ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC. ELSA LINKE
K111594 06/07/2011 ZOLL E SERIES ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS CHUCK KOLIFRATH
K111801 06/27/2011 SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. Diane Brinza


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