FDA 510(k) Decisions During October, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K122913 10/19/2012 AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 MEDTRONIC INC. MARY E DONLIN
K122811 10/12/2012 CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE MEDTRONIC INC. JACQUELINE A HAUGE
K121484 10/19/2012 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M COMPANY SUZANNE LEUNG
K121741 10/18/2012 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) 4-WEB, INC. RICH JANSEN, PHARM, D.
K121876 10/19/2012 VERTECEM II CEMENT KIT AAP BIOMATERIALS GMBH VOLKER STIRNAL
K113602 10/31/2012 AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K121721 10/15/2012 LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) ABBOTT MEDICAL OPTICS INC ABBAS M BOHRA
K122137 10/26/2012 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K122446 10/26/2012 LIQUIDBAND FLOW CONTROL ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD MICHAEL BROWNE
K120148 10/02/2012 AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW ADVANCED ORTHOPAEDIC SOLUTIONS, INC. JULIE GLENDRANGE
K111518 10/03/2012 STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111519 10/03/2012 STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K122044 10/04/2012 STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS NANCY CHU
K112087 10/15/2012 TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS ADVANCED STERILIZATION PRODUCTS NANCY CHU
K122985 10/26/2012 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. JULIE TOM WING
K120889 10/15/2012 AESKUSLIDES ANA HEP-2 AESKU DIAGNOSTICS HELENE PAXTON
K121379 10/11/2012 PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY AIRON CORPORATION G. ERIC GJERDE
K122133 10/02/2012 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP
K121272 10/15/2012 PROTECH DENT AKERVALL TECHNOLOGIES INC SASSA AKERVALL
K122757 10/05/2012 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ, PH.D.
K120401 10/05/2012 ALAMO T ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K121805 10/16/2012 AMS LARGE PORE POLYPROPHLENE MESH AMERICAN MEDICAL SYSTEMS RENEE MELLUM
K121483 10/15/2012 REUSABLE CUTANEOUS ELECTRODE AMPCARE, LLC DIANE RUTHERFORD
K121697 10/15/2012 FINGERTIP PULSE OXIMETER ANDON HEALTH CO., LTD LIU YI
K122130 10/31/2012 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
K120340 10/19/2012 VENUS FACET SCREW SYSTEM APOLLO SPINE, INC. CHRISTINE SANTAGATE
K122619 10/02/2012 EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET APPLIED MEDICAL JESSICA CHO
K111981 10/12/2012 TREGOR DUAL MOBILITY ACETABULAR SYSTEM ASTON MEDICAL CATHERINE GLOSTER
K122078 10/31/2012 LOFRIC PRIMO, LOFRIC HYDRO-KIT ASTRA TECH, INC. ALLISON C KOMIYAMA
K120199 10/12/2012 GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY BECKMAN COULTER, INC BEVERLY HARDING
K122838 10/17/2012 LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK BIO-RAD LABORATORIES SUZANNE PARSONS
K122472 10/26/2012 VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION JACKIE BUCKLEY
K121002 10/12/2012 ETEST CEFTAROLINE BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K122547 10/15/2012 GRAM POSTITVE CLINDAMYCIN BIOMERIEUX, INC. ELIZABETH LANDON
K122277 10/22/2012 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K121624 10/12/2012 BIOMET MICROFIXATION NEURO PLATING SYSTEM BIOMET MICROFIXATION SHERYL MALMBERG
K122989 10/24/2012 BIOMET LATERAL SPACER SYSTEM BIOMET SPINE (AKA EBI, LLC) MARGARET F CROWE
K121973 10/30/2012 BIOPRO HEMI-EDGE TOE SYSTEM BIOPRO, INC. AL LIPPINCOTT
K113650 10/03/2012 ORTHOFIX SCREW BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC JUAN TEZAK
K121754 10/10/2012 BLUE SUI SLING BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K122924 10/24/2012 CRE FIXED WIRE BALLON DILATION CATHETER BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K123024 10/26/2012 TORQUE DEVICE BOSTON SCIENTIFIC CORPORATION RACHEL OWENS
K122856 10/17/2012 CHARTER GUIDEWIRE BRIVANT, LTD. KENNETH WALSH
K120093 10/05/2012 BTL ELITE BTL INDUSTRIES, INC MARCY MOORE
K120728 10/22/2012 PHASIX PLUG AND PATCH C.R. BARD INC SHERMA WINSTON
K122984 10/22/2012 ATLAS GOLD PTA DILATATION CATHETER C.R. BARD, INC. JENNIFER LOGVIN
K120785 10/25/2012 OMNI 3 OXYGEN SYSTEM CAIRE, INC. BRIAN JARRELL
K121768 10/31/2012 COSENSE CAPNIA, INC. JULIE BLACKLOCK
K122956 10/25/2012 FUSELOX LUMBAR INTERBODY FUSION DEVICE CAPTIVA SPINE RICH JANSEN
K122332 10/16/2012 TOWERLOX PEDICLE SCREW SYSTEM CAPTIVA SPINE RICH JANSEN
K122241 10/24/2012 IMAGEN3D CARDIOVASCULAR IMAGING TECHNOLOGIES MELANIE HASEK
K122987 10/25/2012 STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. MAUREEN MCDONNELL
K121849 10/18/2012 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE CAREFUSION JOY GREIDANUS
K122523 10/23/2012 CARESTREAM VUE PACS CARESTREAM HEALTH, INC. ALEXANDRA CHAMBERLAIN
K122215 10/26/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. TANYA EBERLE
K122463 10/11/2012 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K122314 10/31/2012 QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K121758 10/09/2012 CERNER FETALINK+(VERSION1.0) CERNER CORP. SHELLEY S LOOBY
K120706 10/04/2012 NIRVANA A PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K120751 10/03/2012 NIRVANA B PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K121317 10/12/2012 COCHLEAR BAHA IMPLANT SYSTEM COCHLEAR AMERICAS SEAN BUNDY
K121458 10/01/2012 SPEEDICATH COMPACT SET (12/18 FR) COLOPLAST A/S BRIAN SCHMIDT
K121457 10/02/2012 SPEEDICATH COMPACT SET (12 FR) COLOPLAST CORP. BRIAN SCHMIDT
K122478 10/31/2012 MODIFIED TREVO RETRIEVER CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K120595 10/12/2012 UNISYN PLUS HIP STEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K122972 10/24/2012 CDC ZIRCONIA BLANKS CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL DENTAL LA JERRY DOVIACK, CDT
K122796 10/11/2012 CXI SUPPORT CATHETER COOK, INC. MOLLY BUSENBARK
K121728 10/05/2012 TIGER SPINE SYSTEM CORELINK LLC J.D. WEBB
K122099 10/05/2012 BENCOX II STEM, BENCOX METAL HEAD CORENTEC CO., LTD J.S. DANIEL
K121563 10/05/2012 CORIN TRIFIT TS HIP CORIN USA LUCINDA GERBER
K123109 10/23/2012 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN RENEE BORGESANO
K122531 10/09/2012 SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T COVIDIEN TED KUHN
K123066 10/16/2012 ACCUMESH DEPLOYMENT SYSTEM COVIDIEN LLC ELIZABETH MCMENIMAN
K122280 10/23/2012 IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM CYDEN LIMITED AUSTIN SPEIER
K121287 10/03/2012 HT-WEDGE D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L SUSAN PAVELKO
K122445 10/12/2012 AESPIRE 7900, AESPIRE VIEW DATEX-OHMEDA JAMES RASKOB
K122331 10/15/2012 CAVITY VARNISH DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K122123 10/02/2012 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY JULIE VAFIDES
K122395 10/31/2012 DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS DEPUY ORTHOPAEDICS, INC. MEGAN BURNS
K121862 10/31/2012 REX ANTERIOR CERVICAL PLATE SYSTEM DIO MEDICAL CO., LTD. APRIL LEE
K122499 10/18/2012 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC KEN FISHER
K121881 10/18/2012 DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. CURTIS JENSEN
K121845 10/19/2012 SDX SYSTEM DYN'R SAS TIM LAWTON
K122574 10/12/2012 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 EDAN INSTRUMENTS, INC. RANDY JIANG
K122858 10/03/2012 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II ELITECHGROUP DEBRA K HUTSON
K113219 10/19/2012 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCLNTYRE
K113726 10/05/2012 EPOC CHLORIDE TEST AND EPOC CREATININE TEST EPOCAL, INC. ROY LAYER
K112121 10/31/2012 ERGOSELECT/GE ERGOLINE GMBH ANDREA PECSI
K122511 10/01/2012 ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K123141 10/25/2012 ENSEAL TRIO TISSUE SEALING DEVICE ETHICON ENDO-SURGERY, LLC EMILY KREUTZKAMP
K122798 10/11/2012 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL EXACTECH, INC. AMY TAULBEE
K121684 10/01/2012 NOVATION LPI PRIME FEMORAL STEM EXACTECH, INC. VLADISLAVA ZAITSEVA
K121597 10/02/2012 ESON NASAL MASK FISHER & PAYKEL HEALTHCARE LIMITED JAMES THOMPSON
K121722 10/11/2012 ESA620 ELECTRICAL SAFETY ANALYZER FLUKE BIOMEDICAL JOHN NELSON
K122694 10/25/2012 GE 8CH FOOT ANKLE COIL GE HANGWEI MEDICAL SYSTEMS CO., LTD. GLEN SABIN
K122921 10/05/2012 C1-6-D ULTRASOUND TRANSDUCER GE HEALTHCARE BRYAN BEHN
K122114 10/03/2012 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE BRYAN BEHN
K120125 10/03/2012 SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. ROBIN MARTIN
K120641 10/17/2012 GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE GLOBAL MEDI PRODUCTS ROBERT O DEAN
K121732 10/31/2012 CANOPY LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL INC. SARAH MARIE FITZGERALD
K122226 10/01/2012 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC. MERIAM YOUSSEF
K122028 10/23/2012 AURICAL HIT GN OTOMETRICS DANIEL KAMM
K122262 10/25/2012 ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. ERICA DIAZ
K121993 10/25/2012 SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT HEIDELBERG ENGINEERING GMBH DIANE HORWITZ, PH.D.
K120947 10/17/2012 THS INSTRUMENT TRAY HOLOGIC, INC. SARAH FAIRFIELD
K122308 10/01/2012 AXSOS DISTAL LATERAL FEMUR TS LONG PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE M FITTS
K122325 10/26/2012 SKINTEMP II HUMAN BIOSCIENCES, INC. JACK SLOVICK
K113020 10/25/2012 IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K122465 10/16/2012 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K121581 10/17/2012 BOX PEEK VBR SYSTEM, INNOVASIS, INC. MARSHALL C MCCARTY
K121682 10/04/2012 ACTIVE SCREW BONE SCREW INTELLIGENT IMPLANT SYSTEMS, LLC MICHAEL J NUTT
K113706 10/17/2012 ENDOWRIST STAPLER SYSTEM INTUITIVE SURGICAL, INC. MEGHNA SRIDHARAN
K121921 10/25/2012 INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS INTUITIVE SURGICAL, INC. CHERECE L JONES
K120053 10/18/2012 IPS E.MAX PRESS - ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG DONNA MARIE HARTNETT
K122697 10/05/2012 PORTA 100HF JOB CORPORATION TAKAHIRO HARUYAMA
K120499 10/05/2012 ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K121883 10/11/2012 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT KCI USA, INC. (KINETIC CONCEPTS, INC.) SHANNON SCOTT
K121047 10/04/2012 HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM KJ MEDITECH CO., LTD PRISCILLA CHUNG
K122025 10/09/2012 BRIGHTGLASS BRIGHTGLASS M KTK MEDICAL SUPPLIES GMBH THOMAS LOTTERMOSER
K121980 10/19/2012 ZIRPRIME KURARAY NORITAKE DENTAL INC. IVAN WASSERMAN
K122050 10/22/2012 CPRMETER CPR FEEDBACK DEVICE LAERDAL MEDICAL A/S DAN DILLION
K120998 10/01/2012 SOLSTICE CROSS CONNECTOR LIFE SPINE RANDY LEWIS
K121083 10/11/2012 TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA LOMA VISTA MEDICAL TIFFINI DIAGE
K122131 10/17/2012 POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) MATANG MFG. SDN. BHD. LESLIE LEONG
K122589 10/05/2012 DFP4343C7 MDI CONSULTANTS, INC. JIGAR SHAH
K122911 10/19/2012 VERSAFITCUP CC TRIO EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K113678 10/01/2012 INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDELA AG ADRIENNE LENZ
K122497 10/15/2012 ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM MEDICAL DESIGN LLC. KRISTI VONDRA
K121716 10/05/2012 TBS INSIGHT MEDIMAPS GROUP SA CHRISTOPHE LELONG
K122023 10/04/2012 MIXJECT WITH SPRAY HEAD MEDIMOP MEDICAL PROJECTS, LTD. LLANIT GOLDGRABER
K120460 10/01/2012 SMARTLUX MEDMIX CO., LTD PETER CHUNG
K122896 10/18/2012 COUGAR LS 15 LATERAL CAGE SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K122916 10/19/2012 JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM MEDRAD, INC. BRIT BAIRD
K122092 10/23/2012 MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM MEDRANGE CORPORATION KUOFANG HUANG
K120930 10/26/2012 CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K122862 10/03/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K122434 10/31/2012 MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL MEDTRONIC XOMED ANTOINE KOUCHAKJY
K122231 10/04/2012 XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD APRIL LEE
K121962 10/19/2012 PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B MEGO AFEK AC LTD ALEX RAPEL
K122384 10/04/2012 MINISPIR MIR MEDICAL INTL. RESEARCH SRL GERDA VAN HOUTS
K122450 10/03/2012 MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS MITSUBISHI HEAVY INDUSTRIES, LTD. YOICHI WAKIYAMA
K112826 10/10/2012 NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR MOOR INSTRUMENTS LTD. XIABING HUANG HUANG
K111588 10/26/2012 LEGACY-500 MT TABLES, LLC MILBURN TENNIS
K122882 10/18/2012 NMI HPICC III NAVILYST MEDICAL, INC. WANDA CARPINELLA
K120831 10/12/2012 ANCHORSURE NEOMEDIC INTERNATIONAL S.L. JEFFREY R SHIDEMAN
K121551 10/23/2012 RESOLUTE FACET SCREW SYSTEM NEUROSTRUCTURES, LLC MEREDITH MAY
K121931 10/19/2012 NONDISPOSABLE STIMULATING INSTRUMENTS NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K122031 10/09/2012 NEXTRA TI HAMMERTOE CORRECTION SYSTEM NEXTREMITY SOLUTIONS, LLC ARTHUR A ALFARO
K113471 10/18/2012 NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113469 10/18/2012 NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113470 10/17/2012 NIPRO SAFE TOUCH HUBER INFUSION SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K122012 10/04/2012 Z-MED Z-MED II NUMED, INC. NICHELLE LAFLESH
K121815 10/23/2012 NUVASIVE SAGE LATERAL PLATE SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K122910 10/11/2012 ARCHON ANTERIOR CERVICAL PLATE SYSTE, NUVASIVE, INCORPORATED CYNTHIA ADAMS
K122267 10/02/2012 GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., AGATA ANTHONY
K121564 10/16/2012 ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 OLYMPUS MEDICAL SYSTEMS CORP. LAURA STORMS-TYLER
K122085 10/17/2012 STINGRAY CERVICAL CAGE OMNI SURGICAL, LP DBA SPINE360 DAVE LAMB
K120765 10/24/2012 VITROS CHEMISTRY PRODUCTS ECO2 SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. GAOZHEN HANG
K122533 10/23/2012 OSSEOFLEX SB INFLATABLE BONE TAMP OSSEON THERAPEUTICS, INC. KEITH BURGER
K120951 10/03/2012 SMARTBUILDER SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K122178 10/11/2012 FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 OSTIAL CORPORATION KAITLIN VON HOFFMANN
K122837 10/15/2012 AUTOJECT 2 FOR GLASSY SYRINGE OWEN MUMFORD, LTD. DARREN MANSELL
K122969 10/25/2012 CLICKFINE PEN NEEDLE P/L BIOMEDICAL LEE LEICHTER
K122971 10/25/2012 CLICKFINE PEN NEEDLE P/L BIOMEDICAL LEE LEICHTER
K122009 10/03/2012 AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER PANASONIC HEALTHCARE CO., LTD. RAM BEDI
K122756 10/02/2012 PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING PENUMBRA, INC. SETH SCHULMAN
K123043 10/25/2012 IRMA C02 MODEL 200101; IRMA AX 200601 PHASEIN AB DAVID WEISSBURG
K121781 10/26/2012 ECHONAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FRANS JACOBS
K122600 10/11/2012 LIFEPAK 1000 DEFIBRILLATOR PHYSIO-CONTROL, INC. MICHELLE ACKERMANN
K122293 10/12/2012 PIONEER STERNAL CABLE PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K112217 10/16/2012 ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER POLICHEM S.A. JOHN NYGAARD
K121688 10/12/2012 MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. KATHLEEN DRAGOVICH
K122843 10/05/2012 MD211G3 21.3" DIAGNOSTIC IMAGING LCD MONITOR PRODIGY TECHNOLOGY CONSULTANT CO., LTD. ANGUS HSU
K120110 10/04/2012 ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET PROFIT POINT MANUFACTURING SDN BHD ROBERT HILL
K121657 10/23/2012 PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR PROTON SYSTEMS MIKE BEGALA
K122149 10/17/2012 QBTES QBTECH AB HANS BOSTROM
K112139 10/26/2012 THE CANARY SYSTEM QUANTUM DENTAL TECHNOLOGIES INC JOSH SILVERTOWN
K113867 10/19/2012 LACRICATH LACRIMAL DUCT CATHETER QUEST MEDICAL, INC. AMY CLENDENING-WHEELER
K122642 10/26/2012 ABL90 FLEX RADIOMETER MEDICAL APS MARTIN GABLER
K121696 10/11/2012 WIRELESS THERMOMETER RALING MEDICAL COMPANY WU WEI
K122173 10/19/2012 DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC RAYENCE CO., LTD DAVE KIM
K122348 10/15/2012 QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) MANH-QUYNH CHU
K122292 10/24/2012 RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K122003 10/26/2012 RENEW INSERT RENEW MEDICAL, INC. VICTORIA MACKINNON
K121705 10/23/2012 GEO RESMED LTD. JIM CASSI
K122769 10/09/2012 REMSTAR SE RESPIRONICS, INC. FRANK KADI
K121631 10/05/2012 SIMPLE T NASAL MASK RESPIRONICS, INC. MICHELLE BRINKER
K121344 10/17/2012 NU SLEEP RH ASSOCIATES LLC DANIELA LEVY
K121679 10/11/2012 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS MIKE FLIS
K122228 10/03/2012 LIGAFIX INTERFERENCE SCREW SBM SCIENCES FOR BIO MATERIALS DENIS CLEMENT
K120545 10/23/2012 HX-461 SEERS TECHNOLOGY CO, LTD PETER CHUNG
K120652 10/12/2012 RAPICIDE OPA-28 TEST STRIP SERIM RESEARCH CORP. PATRICIA RUPCHOCK
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