FDA 510(k) Applications Received During September, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123015 09/28/2012 .DECIMAL PHOTON BLOCK .DECIMAL, INC. KYM RUPP
K123010 09/27/2012 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. Xie Qiyi
K123048 09/28/2012 PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K123017 09/28/2012 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K122809 09/13/2012 ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP ADVIN BIOTECH EDWARD TUNG
K122985 09/26/2012 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. JULIE TOM WING
K122783 09/11/2012 PLASMAFIT ACETABULAR CUP AND VITELENE INSERT AESCULAP IMPLANT SYSTEM, INC. JULIE TOM WING
K122734 09/06/2012 AESCULAP NOVOSYN ABSORBABLE SUTURE AESCULAP, INC. KATHY A RACOSKY
K122791 09/12/2012 LYOPLANT ONLAY AESCULAP, INC. DENISE ADAMS
K122736 09/19/2012 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. DAVID LEDWIG
K123018 09/28/2012 ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ PH.D.
K122757 09/07/2012 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ, PH.D.
K122978 09/26/2012 SANICLAVE 102, MODEL RS-SC-102 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT ISAAC ERICKSON
K122753 09/07/2012 EMPOWER CLEAR AMERICAN ORTHODONTICS TRANG ADAMS
K122720 09/05/2012 LIFESTYLES WARM LOVIN PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC DONNA DI GANGI
K122817 09/14/2012 SILVERLON ISLAND WOUND DRESSING ARGENTUM MEDICAL, LLC. WALT BRITTLE
K122854 09/18/2012 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K122690 09/04/2012 ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE ARROW INTERNATIONAL, INC. PAUL AMUDALA
K122892 09/20/2012 MTA2 ROOT AND PULP MATERIALS AVALON BIOMED INC. CAROLYN PRIMUS
K122926 09/24/2012 SUREFLEX STEERABLE GUIDING SHEATH KIT BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K122718 09/05/2012 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP Becton, Dickinson and Company Gregory P Payne
K122995 09/26/2012 INTENSE PULSED LIGHT (IPL) SYSTEMS BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. Diana Hong
K122704 09/04/2012 BEST LOCALIZATION NEEDLE WITH I-125 SEED BEST MEDICAL INTL. DHARMENDRA THAKUR
K123021 09/27/2012 BIOPLEX 2200 EBV IGM KIT Bio-Rad Laboratories Juang Wang
K122838 09/17/2012 LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK Bio-Rad Laboratories SUZANNE PARSONS
K122986 09/26/2012 VIDAS LYME IGG BIOMERIEUX SA CATHERINE FRITSCH
K122979 09/26/2012 VIDAS LYME IGM BIOMERIEUX SA CATHERINE FRITSCH
K122770 09/10/2012 BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K122989 09/26/2012 BIOMET LATERAL SPACER SYSTEM BIOMET SPINE (AKA EBI, LLC) MARGARET F CROWE
K122784 09/11/2012 NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT BIONESS, INC. KIM TOMPKINS
K123008 09/27/2012 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN BIONIME CORPORATION JIGAR SHAH
K122703 09/04/2012 RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K122982 09/26/2012 CRYOLOCK BIOTECH, INC. ROBYN SCOPIS
K122924 09/24/2012 CRE FIXED WIRE BALLON DILATION CATHETER BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K122794 09/12/2012 UPSYLON Y MESH BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K123024 09/28/2012 TORQUE DEVICE Boston Scientific Corporation RACHEL OWENS
K123047 09/28/2012 BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K122752 09/07/2012 FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD BRANAN MEDICAL CORP. Olivia Chan
K122795 09/12/2012 STINGRAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K122856 09/18/2012 CHARTER GUIDEWIRE BRIVANT, LTD. KENNETH WALSH
K122966 09/25/2012 XP200 BTL INDUSTRIES LTD RICHARD VINCINS
K122984 09/26/2012 ATLAS GOLD PTA DILATATION CATHETER C.R. BARD, INC. JENNIFER LOGVIN
K122899 09/21/2012 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT C.R. BARD, INC. AMY HONEY
K123028 09/28/2012 VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH CALDERA MEDICAL, INC. VICKI GAIL
K122852 09/18/2012 PHYSIOSTAR NFC CANDULOR USA, INC. DONNA MARIE HARTNETT
K122956 09/25/2012 FUSELOX LUMBAR INTERBODY FUSION DEVICE CAPTIVA SPINE RICH JANSEN
K122758 09/10/2012 POWERHEART G5 AED CARDIAC SCIENCE CORPORATION KATHLEEN ROBERTS
K122696 09/04/2012 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) CARDINAL HEALTH, INC. TATYANA BOGDAN
K122987 09/26/2012 STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. MAUREEN MCDONNELL
K122699 09/04/2012 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K123020 09/28/2012 BLIP MODEL BP-700WF CAREMATIX INC. SUKHWANT KHANUJA
K122873 09/19/2012 VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS CAREMED SUPPLY, INC. MICHAEL LEE
K122938 09/24/2012 FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH CARL ZEISS MEDITEC AG JUDY BRIMACOMBE
K122888 09/20/2012 CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM CDR SYSTEMS, INC. CARL DENIS
K122813 09/13/2012 HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K122968 09/25/2012 NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 COLOPLAST CORP. MARGARET BATCHELDER
K122726 09/05/2012 CPI RAD VISION COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K122870 09/19/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K122991 09/26/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K122972 09/26/2012 CDC ZIRCONIA BLANKS CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL JERRY DOVIACK, CDT
K122716 09/05/2012 PLASMATRODE SALINE SAFE TUR ELECTRODE COOK IRELAND LTD NORA O'CONNOR
K122940 09/24/2012 ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 COOK, INC. ELYSIA EASTON
K122917 09/25/2012 CODA BALLOON CATHETER COOK, INC. ELYSIA EASTON
K122796 09/12/2012 CXI SUPPORT CATHETER COOK, INC. MOLLY BUSENBARK
K122937 09/24/2012 SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) COOK, INC. AMBER BROWN
K123002 09/27/2012 VITAL SYNC SYSTEM COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. KELSEY LEE
K122781 09/11/2012 RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H MARY MELLOWS
K122974 09/26/2012 TRYOUT-VPS HOLDING PASTE CROWN DELTA CORP. MARK KONOPKA
K122871 09/19/2012 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K122927 09/24/2012 OXICARE FINGERTIP PULSE OXIMETER DELBIO INCORPORATED NICKY PAN
K122869 09/19/2012 MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K122793 09/12/2012 LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DIASORIN, INC. JOHN ESKDALE
K122872 09/19/2012 INTERVERTEBRAL BODY FUSION DEVICE DIO MEDICAL CO., LTD. APRIL LEE
K123030 09/28/2012 COMPRESSOR NEBULIZER MODEL MCN-S600XX DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C LEON LU
K122768 09/10/2012 GENESIS DORNIER MEDTECH AMERICA, INC. JOHN J SMITH
K122922 09/24/2012 E-BEAM ND: YAG LASER ECLIPSE AESTHETICS, LLC TOM OBRIEN
K122879 09/19/2012 EEGER4 MODEL 4.3 EEG SOFTWARE LLC HOWARD LIGHTSTONE
K122858 09/18/2012 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II ELITECHGROUP DEBRA K HUTSON
K123038 09/28/2012 SWISS LITHOBREAKER EMS ELECTRO MEDICAL SYSTEMS SA SUZANNE GOODMAN
K122820 09/14/2012 VIKY UP ENDOCONTROL HUGUEL CARINE
K122748 09/07/2012 ENGLER 25K SERIES ULTRASONIC INSERTS ENGLER ENGINEERING CORP. JOEL KATZ
K122797 09/12/2012 ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K122814 09/13/2012 GALLEON PEDICLE SCREW SYSTEM EVEREST SPINE, LLC CHRISTINA VACCA
K122798 09/12/2012 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL EXACTECH, INC. AMY TAULBEE
K122702 09/04/2012 BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR FILLIGENT LIMITED KAI DEUSCH
K122932 09/24/2012 SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT FOGLESS INTERNATIONAL AB JASON WALTON
K123041 09/28/2012 VASOSTAT HEMOSTASIS DEVICE FORGE MEDICAL INC. MASON DIAMOND
K122954 09/25/2012 CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 FOUNDRY NEWCO XI, INC. MICHAEL KOLBER
K122694 09/04/2012 GE 8CH FOOT ANKLE COIL GE HANGWEI MEDICAL SYSTEMS CO., LTD. GLEN SABIN
K122921 09/24/2012 C1-6-D ULTRASOUND TRANSDUCER GE HEALTHCARE BRYAN BEHN
K122893 09/20/2012 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) GEENLI PLASTIC CO, LTD CHU XIAOAN
K122894 09/20/2012 GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC GEISTLICH PHARMA AG DANIEL A KRACOV
K122948 09/24/2012 GEM-STIM COMBO STIMULATOR GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K122944 09/24/2012 GEMORE TRUE SINE INTERFERENTIAL STIMULATOR GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K122832 09/17/2012 MOBICATH TRANSSEPTAL NEEDLE Greatbatch Medical DENISE THOMPSON
K122687 09/04/2012 BLOOD CULTURE HOLDER GREINER BIO-ONE NORTH AMERICA, INC. Judi Smith
K122705 09/04/2012 HUMICARE D900 GRUNDLER GMBH JIM CASSI
K122961 09/25/2012 WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K122904 09/21/2012 WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K122912 09/21/2012 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., AHNEO YANG
K122920 09/24/2012 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) HEBEI LEADER PLASTIC CO., LTD CHU XIAOAN
K122886 09/20/2012 NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING HEMOSTASIS, LLC BERNARD HORWATH
K122721 09/05/2012 AG GUFFILL HOSPITECH RESPIRATION LTD. YORAM LEVY
K122741 09/07/2012 HOVEROUND TEKNIQUE HOVEROUND CORP. ROBERT MUNCH
K122707 09/04/2012 HOVERROUND TEKNIQUE HOVEROUND CORP. ROBERT MUNCH
K122853 09/18/2012 NOVEL FIT AND FILL STEM HOWMEDICA OSTEONICS CORP VALERIE GIAMBANCO
K122951 09/25/2012 XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 ICAD, INC. JOHN A DELUCIA
K122890 09/20/2012 INION CPS ORBITAL PLATES INION OY KATI MARTTINEN
K122689 09/04/2012 INOBLENDER INO THERAPEUTICS ROBERT BOVY
K122923 09/24/2012 QUANTA FLASH ENA7 INOVA DIAGNOSTICS, INC. MICHAEL MAHLER
K122953 09/25/2012 OMNIPOD INSULIN MANAGMENT SYSTEM INSULET CORPORATION MICHAEL J DOYLE
K122804 09/13/2012 ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM INTAI TECHNOLOGY CORP. KEVIN WANG
K123000 09/27/2012 INTEGRA TOTAL FOOT SYSTEMS INTEGRA LIFESCIENCES CORPORATION STEPHEN H BEIER
K122897 09/21/2012 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 INVIVO CORPORATION LANCE AULABAUGH
K122740 09/06/2012 JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN JETPREP, LTD. JOHN SMITH, MD, JD
K123022 09/28/2012 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Allison C Komiyama
K122697 09/04/2012 PORTA 100HF JOB CORPORATION TAKAHIRO HARUYAMA
K122877 09/19/2012 RANGE SPINAL SYSTEM, SMALL STATURE K2M, INC. NANCY GIEZEN
K122800 09/12/2012 INNER PEACE KAMABRY, INC., DBA INNER PEACE FOR WOMEN YOLANDA SMITH
K122983 09/26/2012 KSEA BIPOLAR ELECTRODE KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K122860 09/18/2012 KLS MARTIN RECON TALON KLS MARTIN L.P. JENNIFER DAMATO
K122829 09/17/2012 LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS LENSAR, INC. SHIRLEY K MCGARVEY
K122848 09/18/2012 LENSTEC LC INJECTION SYSTEM LENSTEC, INC. JIMMY CHACKO
K123037 09/28/2012 LIGHTSCALPEL LIGHTSCALPEL LLC DAVID WALTERS
K123031 09/28/2012 BWF-5 MEDICAL LASER SERIES LITECURE, LLC LIANG LU
K123014 09/27/2012 LITECURE THERAPY SYSTEM MODEL LTS-1500 LITECURE, LLC LIANG LU
K122836 09/17/2012 AFFIRM BREAST BIOPSY GUIDANCE SYSTEM LORAD, A HOLOGIC CO. GAIL YAEKER-DAUNIS
K122911 09/21/2012 VERSAFITCUP CC TRIO EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K122973 09/26/2012 AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE MEDGYN PRODUCTS, INC. STEPHANIE BLAIR
K122764 09/10/2012 RAPID STRAND RX MEDI-PHYSICS, INC. DAVID RISLEY
K122885 09/20/2012 MEDISIZE GOLD HEATER AND BOOSTER T-PIECE MEDISIZE BV IFFAT NOOR
K122850 09/18/2012 TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES MEDITECH ADVISORS, LLC Sharyn Orton
K122949 09/24/2012 MEDLINE SUCTION COAGULATOR MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K122896 09/21/2012 COUGAR LS 15 LATERAL CAGE SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K122916 09/21/2012 JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM MEDRAD, INC. BRIT BAIRD
K122760 09/10/2012 AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC. JULIA A NELSON
K122914 09/21/2012 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE MEDTRONIC INC. JULIA A NELSON
K122827 09/14/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 MEDTRONIC INC. MARY E DONLIN
K122913 09/21/2012 AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 MEDTRONIC INC. MARY E DONLIN
K122811 09/13/2012 CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE MEDTRONIC INC. JACQUELINE A HAUGE
K122862 09/17/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K123027 09/28/2012 CAPSTONE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. LEE GRANT
K122806 09/13/2012 IMAGE WORKS PANOURA MIC INTERNATIONAL IZUMI MARUO
K122840 09/17/2012 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CHUCK SMITH
K123007 09/27/2012 VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM MICOBIOMED CO, LTD Priscilla Chung
K123016 09/27/2012 VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS MICOBIOMED CO, LTD Priscilla Chung
K122766 09/10/2012 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY MICROGENICS CORP. KAREN LEE
K122762 09/10/2012 ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR MICROSULIS MEDICAL LIMITED STUART MCINTYRE
K123004 09/27/2012 MIRA LASERS MIRA LASERS LLC Diana Hong
K122943 09/24/2012 MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER MOOR INSTRUMENTS LTD. STEWART LILLINGTON
K123050 09/28/2012 EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) NANTONG BIOTECHNOLOGY CO., LTD. JOE XIA
K122882 09/20/2012 NMI HPICC III NAVILYST MEDICAL, INC. WANDA CARPINELLA
K122767 09/10/2012 NMI PORT NAVILYST MEDICAL, INC. Lorraine M Hanley
K122925 09/24/2012 NEW STETIC ARTIFICIAL TEETH NEW STETIC JOHN OBRIEN
K123006 09/27/2012 AIR BARRIER SYSTEM (ABS) NIMBIC SYSTEMS, INC HARVEY KNAUSS
K122952 09/25/2012 NIPRO PUREFLUX-L HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEAORGE
K122874 09/19/2012 POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE NITRILIST GLOVES MANUFACTURING SDN BHD LAU SIONG HUT
K122998 09/27/2012 BLUE POWDERED NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS ANTHONY GIACCIO
K122727 09/05/2012 BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS MICHAEL RIORDAN
K123026 09/28/2012 TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO NORTHSTAR HEALTHCARE HOLDINGS ANTHONY GIACCIO
K122788 09/11/2012 TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O NORTHSTAR HEALTHCARE HOLDINGS MICHAEL RIORDAN
K122688 09/04/2012 NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K123013 09/28/2012 ENDOSCOPIC INTRODUCER NOVADAQ TECHNOLOGIES, INC. TIM VERSPAGEN
K122711 09/04/2012 FACIAL SPA NUSKIN PAUL RUBIN
K122777 09/11/2012 NBX - NON BRIDGING EXTERNAL FIXATOR HAND NUTEK ORTHOPAEDICS, INC. PETER MINCIELI
K122742 09/07/2012 NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM NUVASIVE, INC. Sheila Bruschi
K122910 09/21/2012 ARCHON ANTERIOR CERVICAL PLATE SYSTE, NUVASIVE, INCORPORATED Cynthia Adams
K122818 09/14/2012 OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT RONALD S WARREN
K122831 09/17/2012 VIDEO SYSTEM CENTER OLYMPUS MEDICAL SYSTEMS CORP. SHERI L MUSGNUNG
K122759 09/10/2012 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) OMEGA LABORATORIES, INC. ROBERT J BARD
K122875 09/19/2012 ORICARE L2700 ORICARE, INC. DAVID T JAMISON
K122901 09/21/2012 FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM ORTHOFIX JACKI GEREN
K122936 09/24/2012 ANKLE TRAUMA SYSTEM ORTHOPRO LLC BROCK JOHNSON
K122958 09/25/2012 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor Inc. MILA DOSKOCIL
K122960 09/25/2012 STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor Inc. MILA DOSKOCIL
K122861 09/18/2012 XTOOL OUROBOROS MEDICAL SHELLEY TRIMM
K122837 09/17/2012 AUTOJECT 2 FOR GLASSY SYRINGE OWEN MUMFORD, LTD. DARREN MANSELL
K122969 09/26/2012 CLICKFINE PEN NEEDLE P/L Biomedical Lee Leichter
K122971 09/26/2012 CLICKFINE PEN NEEDLE P/L Biomedical Lee Leichter
K122805 09/13/2012 PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR PARCUS MEDICAL, LLC PAUL VAGTS
K122857 09/18/2012 HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 PEGASUS RESEARCH CORP. KENNETH MILLER
K122772 09/10/2012 PENUMBRA DDC CATHETERS PENUMBRA, INC. SETH SCHULMAN
K122756 09/07/2012 PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING PENUMBRA, INC. SETH SCHULMAN
K122997 09/27/2012 23GA CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL LTD. RYAN O'LEARY
K122905 09/21/2012 PEREGRINE 23GA CURVED LASER PROBE PEREGRINE SURGICAL, LTD. RYAN O'LEARY
K122975 09/26/2012 GKS PRIME FLEX CR TOTAL KNEE SYSTEM PERMEDICA NATALIE J KENNEL
K122834 09/17/2012 POLYSITE IMPLANTABLE INFUSION PORTS Perouse Medical Isabelle Jeanty
K123035 09/28/2012 SEAL ONE Perouse Medical CAROLINE DAURELLE
K123043 09/28/2012 IRMA C02 MODEL 200101; IRMA AX 200601 PHASEIN AB DAVID WEISSBURG
K122907 09/21/2012 FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER POLYMED THERAPEUTICS, INC TERRI WALLACE
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