FDA 510(k) Applications Received During March, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K130536 03/07/2013 EXPORT ADVANCE ASPIRATION CATHETER MEDTRONIC INC. COLLEEN MULLINS
K130664 03/12/2013 HYRDROMAX HMEF A-M SYSTEMS PAUL DRYDEN
K130762 03/29/2013 AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K130764 03/29/2013 AUDIT MICROCV VITAMIN D LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K130590 03/14/2013 AAP CANNULATED SCREW 2.0 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K130627 03/15/2013 SWING-OFF SCREW ADVANCED INTERVENTIONAL TECHNOLOGY, LLC EDUARDO MARCH
K130625 03/18/2013 12MM AND 13MM TIBIAL NAILS ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K130887 03/29/2013 S4C NAVIGATION INSTRUMENTS AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K130596 03/07/2013 CAIMAN SEAL AND CUT TECHNOLOGY AESCULAP, INC. DENISE ADAMS
K130535 03/01/2013 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION AGAMATRIX INC WILLIAM H MCGRAIL
K130702 03/18/2013 AIRSONETT AIR-4 AIRSONETT, AB CONSTANCE G BUNDY
K130657 03/12/2013 LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE ALL MEDICUS CO., LTD PRISCILLA CHUNG
K130548 03/05/2013 EPICAGE INTERBODY FUSION DEVICE ALPHATEC SPINE, INC. NADINE SMITH
K123834 03/21/2013 EASYSTAND BANTAM MEDIUM ALTIMATE MEDICAL, INC. STACEY FRANK
K130671 03/12/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K130538 03/05/2013 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
K130677 03/14/2013 APTUS HELI-FX AORTIC SECUREMENT SYSTEM APTUS ENDOSYSTEMS, INC. BURT GOODSON
K130730 03/18/2013 V-STICK VASCULAR ACCESS SET ARGON MEDICAL JENNIFER BONACCI
K130676 03/15/2013 AMBIO REMOTE HEALTH MONITORING SYSTEM ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH KEVIN JONES
K130876 03/29/2013 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL, INC. ELIZABETH DUNCAN
K130675 03/14/2013 ARTHREX UNIVERS II CA HEADS ARTHREX, INC. COURTNEY SMITH
K130693 03/20/2013 AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM ASEPTICO, INC. CHERIE TREGONING
K130521 03/07/2013 ISOLATOR LINEAR PEN ATRICURE, INC. REBECCA WALTERS
K130514 03/01/2013 AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT AUDIFON-USA INC. JANE E PERRONE
K130417 03/01/2013 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S AUDIFON-USA INC. JANE E PERRONE
K123099 03/07/2013 ALPHA-STIM MODEL ALPHA-STIM 100; BODY-STIM, BEST-RSI, BIOMODULATOR, MODEL BEST-PRO1; BEST-AV1; INTERX5000 MODEL INTERX50 AVAZZIA, INC. TAMMY LAHUTSKY
K130576 03/07/2013 CELSITE IMPLANTABLE ACCESS PORT SYSTEMS B. BRAUN INTERVENTIONAL SYSTEMS INC. AMBER KINGSTON
K130857 03/28/2013 PRONTOSAN WOUND GEL X B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K130498 03/08/2013 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC. HOWARD L SCHRAYER
K130531 03/01/2013 ULTRAFUSE BAXTER HEALTHCARE CORP. GRETCHEN MURRAY
K130760 03/20/2013 ELECTROSURGICAL GENERATOR BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD. LIGANG MAO
K130641 03/13/2013 LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE BINDER BIOMEDICAL, INC LAWRENCE BINDER
K130528 03/01/2013 BIOPLEX 2200 APLS IGM BIO-RAD LABORATORIES JUANG WANG
K130761 03/20/2013 LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K130860 03/28/2013 VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION EBONY MCKINNIES
K130681 03/21/2013 ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER BIOLITEC SIA HARRY HAYES
K130610 03/07/2013 SIRIUS FEMORAL STEM BIOMET, INC. BECKY EARL
K130537 03/01/2013 BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K130716 03/15/2013 BIORETEC ACTIVASCREW INTERFERENCE BIORETEC LTD MARI RUOTSALAINEN
K130602 03/11/2013 LASSO NAV DUO LOOP CATHETER BIOSENSE WEBSTER, INC. JOHN JIMENEZ
K130777 03/25/2013 INBODY BIOSPACE CORPORATION LIMITED DANIEL KAMM, P.E.
K130775 03/27/2013 DUET SYSTEM BIOVIEW LTD. ORLY MAOR
K130804 03/25/2013 UROMAX ULTRA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORPORATION LAUREN RUSSO
K130621 03/08/2013 BROADMASTER HEALTHCARE SYSTEM BROADMASTER BIOTECH CORPORATION ROGER LAI
K130831 03/26/2013 MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC FRAN WHITE
K130101 03/19/2013 BYTECH BYTECH DONGTAI CO., LTD. CHU XIAOAN
K130792 03/22/2013 LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM C.R. BARD, INC. CHRISTOPH WAGNER VON HOFF
K130786 03/21/2013 SLEEK OTW PTA CATHETER C.R. BARD, INC. FIONA NI MHULLAIN
K130678 03/13/2013 BIOMARC GOLD FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K130567 03/04/2013 DR LONG LENGTH IMAGING SOFTWARE CARESTREAM HEALTH, INC. CAROLYN WAGNER
K130648 03/11/2013 FORUM GLAUCOMA WORKPLACE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K130549 03/04/2013 INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR CARL ZEISS MEDITEC INC SARAH HARRINGTON
K130834 03/28/2013 R7 CEFLA S.C. CLAUDE BERTHOIN
K130618 03/21/2013 SFI-ANCHOR CENDRES & METAUX SA TANJA BONGNI
K130752 03/19/2013 DYNASENSE SYSTEM CENTAURI MEDICAL, INC. LORI ADELS
K130551 03/04/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM. D.
K130461 03/04/2013 STALIF X CENTINEL SPINE INC. JUSTIN EGGLETON
K130853 03/28/2013 IDYS(TM) C CLARIANCE JANICE M HOGAN
K130652 03/15/2013 VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT CONSENSUS ORTHOPEDICS, INC. MATTHEW HULL
K130766 03/29/2013 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE COOK, INC. DAVID LEHR
K130673 03/15/2013 LOSPA TOTAL KNEE REPLACEMENT SYSTEM CORENTEC CO., LTD J.S. DANIEL
K130634 03/11/2013 CORIN METAFIX HIP STEM CORIN U.S.A. LUCINDA GERBER
K130744 03/19/2013 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER COVIDIEN DIANE REED
K130796 03/29/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN KELSEY LEE
K130782 03/21/2013 ACCUMESH DEPLOYMENT SYSTEM COVIDIEN LLC JOSE MARQUEZ
K130623 03/08/2013 BARRX CHANNEL RFA ENDOSCOPIC CATHETER COVIDIEN LLC RICHELLE HOVER
K130725 03/18/2013 MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DOLLY MISTRY
K130717 03/15/2013 ENDO GIA RELOAD COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE KATHERINE ROBERTSON
K130532 03/01/2013 IDRIVE ULTRA STERILIZATION TRAY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE KATHERINE ROBERTSON
K130663 03/12/2013 BESTFIT2 NASAL MASK CURATIVE MEDICAL INC. AMY MCKINNEY
K130828 03/26/2013 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K130742 03/19/2013 POWEDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DAHOON PLASTIC CO., LTD. CHU XIAOAN
K130861 03/28/2013 MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) DAKO NORTH AMERICA, INC. JENNIFER M CHAMBERS
K130654 03/20/2013 CRYSTAL ULTRA DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) SCOTT ATKIN
K130476 03/18/2013 ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE DENTAL MORELLI LILIAN LLULL
K130680 03/22/2013 ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS DENTSOLL, INC. DAVID C FURR
K130862 03/28/2013 CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K130539 03/07/2013 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K130814 03/25/2013 RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K130571 03/04/2013 DEVON CIRONA 6100 DVT DEVON MEDICAL INC. RUTH WU
K130469 03/01/2013 LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 DIASORIN, INC. KELLY SAUER
K130534 03/01/2013 DIPLOMAT DIPLOMAT DENTAL S.R.O. STUART R GOLDMAN
K130722 03/21/2013 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC LORRI TROTTER
K130580 03/07/2013 RETRACTION PASTE DMG USA, INC. PAMELA PAPINEAU, RAC
K130606 03/13/2013 FMWAND FERROMAGNETIC SURGICAL SYSTEM DOMAIN SURGICAL, INC. CURTIS JENSEN
K130729 03/18/2013 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER DORNIER MEDTECH SYSTEMS JOHN HOFFER
K130711 03/19/2013 INFINITY CENTRALSTATION WITH INFINITY M300 DRAEGER MEDICAL SYSTEMS, INC. TOM OSTROWSKI
K130765 03/20/2013 ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II ELITECHGROUP DEBRA K HUTSON
K130550 03/04/2013 RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW ENCORE MEDICAL, L.P. WILLIAM GARZON
K130793 03/29/2013 NEWA SKIN THERAPY SYSTEM ENDYMION MEDICAL LTD YORAM LEVY
DEN130022 03/05/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
K130556 03/05/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
K130741 03/19/2013 ERCHONIA PL5000 ERCHONIA MEDICAL INC KEVIN WALLS
K130653 03/12/2013 ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU ETHICON ENDO-SURGERY, LLC CAROL HUBBARD
K130723 03/25/2013 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL FAMIDOC TECHNOLOGY CO., LTD REANNY WANG
K123728 03/08/2013 RETRIEVAL BAG FLEXBAR MACHINE CORP. STEPHEN T MLCOCH
K130735 03/18/2013 SYNTHETIC ABSORBABLE SUTURE FOOSIN MEDICAL SUPPLIES INC.LTD DIANA HONG
K130737 03/18/2013 SYNTHETIC ABSORBABLE SUTURE FOOSIN MEDICAL SUPPLIES INC.LTD DIANA HONG
K130542 03/05/2013 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K130759 03/20/2013 HUMELOCK II CEMENTLESS SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K130584 03/12/2013 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. CASARSA ROBERT
K130884 03/29/2013 XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K130626 03/12/2013 MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. PHILIP MALCA
K130374 03/29/2013 OMNI-VUE 2 SYSTEM GENESIS DIGITAL IMAGING, INC. CARL ALLETTO
K130516 03/19/2013 CARDIODAY GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K130785 03/21/2013 SEER 1000 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K130624 03/08/2013 CONI GLOBALMED NICHOLAS CAMPBELL
K130886 03/29/2013 GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION GLOOKO, INC. SHILPA MYDUR
K130559 03/04/2013 MOBICATH BI-DIRECTIONAL GUIDING SHEATH GREATBATCH MEDICAL DENISE THOMPSON
K130691 03/13/2013 ELECTROTHERAPY DEVICE (COMBO UNIT) GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD FIELD FU
K130665 03/12/2013 WONDOFO MULTI-DRUG URINE TEST CUP / PANEL GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K130517 03/15/2013 EZ TRANSPORT CHAIR HARRIS MEDICAL, LLC JAMES WASON, PH.D.
K130473 03/04/2013 NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K130563 03/12/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K130564 03/12/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K130851 03/29/2013 CASCADE HEMODIALYSIS/APHERESIS CATHETER HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
K130647 03/20/2013 XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML HERAEUS KULZER, LLC JAMIE MEARNA
K130582 03/19/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEZE CITY GREEN FOOD CO., LTD. CHU XIAOAN
K130870 03/29/2013 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K130685 03/13/2013 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K130670 03/20/2013 HYDROFERA BLUE PU BACTERIOSTATIC DRESSING HYDROFERA, LLC. HEATHER S SOMERS
K130696 03/18/2013 CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM I-SENS, INC. CHAE YUN LIM
K130888 03/29/2013 SONOPULSE/ SONOPULSE III IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDICOS LTDA TARA CONRAD
K130591 03/07/2013 SUPERA VERITAS IDEV TECHNOLOGIES, INC. DARLENE GARNER
K130572 03/08/2013 INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM IMPLANT DIRECT SYBRON MANUFACTURING LLC INES ARAVENA
K130719 03/18/2013 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER INFRAREDX, INC. STEVE CHARTIER
K130635 03/11/2013 SEVIIN SURFACE REPLACEMENT SHOULDER INGEN ORTHOPEDICS LLC PERRY A GEREMAKIS
K130605 03/07/2013 INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS ROBERT BOVY
K130660 03/22/2013 AUDICOR CPAM WITH SDB (SINGLE SENSOR) INOVISE MEDICAL, INC. EARL ANDERSON
K130598 03/07/2013 INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER INSPIRX, INC. PAUL DRYDEN
K130506 03/11/2013 IMSE P-TLIF INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION JOHN MORAN
K130557 03/04/2013 NEURAGEN 3D INTEGRA LIFESCIENCES CORPORATION STEPHEN H BEIER
K130795 03/22/2013 TITAN INTERACOUSTICS A/S ERIK NIELSEN
K130726 03/18/2013 DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K130856 03/29/2013 BIA / VITALITY ANALYZER IPGDX, LLC KEVIN WALLS
K130829 03/26/2013 IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS IQ IMPLANTS LTD. NATALIA DINERSTHEIN
K130707 03/15/2013 ISIRONA MAGELLAN ISIRONA, LLC THOMAS KROENKE
K130699 03/21/2013 ALEUTIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K130560 03/04/2013 MASTERTORQUE LUX 8900 L KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K130599 03/20/2013 WART FREEZE KONINKLIJKE UTERMOHLEN NV KENNETH R MICHAEL
K130758 03/26/2013 KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER KRONNER PROTOTYPES, INC. RICHARD F KRONNER, M.D.
K130686 03/20/2013 NASAL COMFORT FREEDOM LAKEVIEW SLEEP CENTER ANDY BLACK
K130614 03/20/2013 BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS LAURA CATTABRIGA LAURA CATTABRIGA
K130613 03/20/2013 CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM LAURA CATTABRIGA LAURA CATTABRIGA
K130630 03/12/2013 PLATEAU SPACER SYSTEM TITANIUM LIFE SPINE, INC RANDY LEWIS
K130817 03/25/2013 LTN - LAPAROSCOPIC SURGICAL MESH LIFECELL CORP. JOHN BLEWITT
K130642 03/11/2013 SMR 3-PEGS GLENOIDS LIMACORPORATE S.P.A. CHERYL HASTINGS
K130497 03/01/2013 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION LINVATEC CORPORATION D/B/A CONMED LINVATEC JONATHAN WERNER
K130694 03/22/2013 JR IMPLANT SYSTEM LK CONSULTING GROUP USA, INC. PRISCILLA CHUNG
K130518 03/01/2013 MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER LUTHER NEEDLESAFE PRODUCTS, INC. REBECCA K PINE
K130639 03/11/2013 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K130513 03/01/2013 VOLISTA 400; VOLISTA 600 MAQUET SAS TOSIN YEDESS
K130855 03/29/2013 PTFE SUPER SHEATH INTRODUCER MARTECH MEDICAL PRODUCTS ALEXIS ERAZO
K130687 03/13/2013 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER MEDICAL COMPONENTS INC JESSICA LEO
K130877 03/29/2013 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K130381 03/01/2013 ANGIOJET ULTRA POWER PULSE KIT MEDRAD, INC. AMRA RACIC
K130637 03/12/2013 JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM MEDRAD, INC. BRIT BAIRD
K130608 03/07/2013 QUADCUT MEDTRONIC NAVIGATION, INC. SHARON MCDERMOTT
K130640 03/11/2013 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. KRISTI FRISCH
K130646 03/11/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K130805 03/25/2013 MENICON UNIQUE PH MULTI-PURPOSE SOLUTION MENICON CO. LTD. ELLEN M BEUCLER
K130813 03/25/2013 MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS MENTOR CORP. MARTIN SPRUNCK
K130400 03/01/2013 MERETEC CS, CORTICAL SCREWS MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K130566 03/04/2013 BASIXTOUCH MERIT MEDICAL SYSTEMS, INC. DAN W LINDSAY
K130588 03/07/2013 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. MARTHA FOLAN
K130791 03/22/2013 PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K130547 03/04/2013 ENDOFORM RECONSTRUCTIVE TEMPLATE MESYNTHE LTD RONALD WARREN
K130577 03/14/2013 AZUR PUSHABLE 18 & 35 SYSTEM MICROVENTION, INC. CYNTHIA VALENZUELA
K130784 03/29/2013 SPIROTEL MIR MEDICAL INTL. RESEARCH SRL GERDA VAN HOUTS
K130603 03/26/2013 PATHFAST CTNL CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPORATION JUDI SMITH
K130631 03/08/2013 BUZZY MMJ LABS, LLC VALERIE STAFFEY
K130706 03/19/2013 DUOFLEX COIL SUITE (1.5T) MR INSTRUMENTS, INC. ROBERT BECK
K130738 03/18/2013 ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. DIANA HONG
K130609 03/11/2013 VEEDA 100% COTTON MENSTRUAL TAMPON NATURALENA BRANDS, INC. JOSH ELLIS
DEN130023 03/07/2013 UROLIFT SYSTEM NEOTRACT, INC. Nancy E Isaac
K130651 03/07/2013 UROLIFT SYSTEM NEOTRACT, INC. NANCY E ISAAC
K130816 03/25/2013 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) NEURO RESOURCE GROUP, INC. DAVID TURNER
K130806 03/27/2013 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K130570 03/08/2013 NEUROVISION MEDICAL MOTION SENSOR NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K130774 03/25/2013 UNIVERSAL DISTAL RADIUS SYSTEM NEWCLIP TECHNICS J.D. WEBB
K130879 03/29/2013 NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS NEXUS MEDICAL, LLC HEATHER TURNER
K130565 03/04/2013 SPECULAR MICROSCOPE CEM-530 NIDEK CO., LTD. ARON SHAPIRO
K130601 03/25/2013 BIOROOT RCS NOVOCOL, INC. CORA BRACHO-TROCONIS
K130868 03/29/2013 NUVASIVE DECADE LATERAL PLATE SYSTEM NUVASIVE, INC. CYNTHIA ADAMS
K130820 03/28/2013 EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE, INCORPORATED JEREMY MARKOVICH
K130669 03/12/2013 SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS OLSEN MEDICAL DALENE BINKLEY
K130489 03/08/2013 ELECTRODE, FLEXIBLE SUCTION COAGULATOR OPTIM, LLC. JEFF BARRETT, CEO
K130656 03/18/2013 IFUSION OPTOVUE, INC. WILLIAM "BILL" JACKSON
K130743 03/29/2013 THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL ORTHO KINEMATICS, INC. JOHN J SMITH
K130643 03/14/2013 ACCELEDENT AURA ORTHOACCEL TECHNOLOGIES, INC ZAFFER SYED
K130825 03/26/2013 AZURE ANTERIOR CERVICAL PLATE SYSTEM ORTHOFIX, INC. ALLY BADUEL
K130832 03/28/2013 ORTHOHELIX STAPLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K130655 03/12/2013 RESPONSE SPINE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K130633 03/11/2013 INTRODUCER SETS, MODEL ADELANTE RADIAL OSCOR INC. MILA DOSKOCIL
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K130553 03/11/2013 ABSOCLEAR PHARMAPLAST S.A.E. CYNTHIA PRITCHARD
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K130519 03/01/2013 PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS PHILIPS LIGHTING COMPANY JAMES R CYRE
K130684 03/19/2013 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS NANCY BURKE
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K130790 03/22/2013 LYRIC2 PHONAK LLC JOHN J SMITH
K130579 03/05/2013 PHYSOFT AMS PHYSICIANS SOFTWARE SYSTEMS, LLC LEWIS A MITCHELL
K130667 03/12/2013 POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL PREVENTIVE CARE, INC. ANIL SEGAT
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K130552 03/07/2013 CT PULMONARY ANALYSIS QI IMAGING, LLC RICHARD BALL
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K130337 03/01/2013 RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
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K130773 03/20/2013 TEMPUS PRO PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD. CHRIS HANNAN
K130457 03/11/2013 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL RESONANCE INNOVATIONS LLC RANDALL JONES
K130858 03/28/2013 REVERSE MEDICAL MICROCATHETER REVERSE MEDICAL CORPORATION JEFFREY VALKO
K130750 03/19/2013 RHYTHMIA MAPPING SYSTEM RHYTHMIA MEDICAL, INC LEON AMARIGLIO
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K130734 03/18/2013 SAUFLON MULTIPURPOSE SOLUTION SAUFLON PHARMACEUTICALS, LTD. CHRISTOPHER SMEJKAL
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K130830 03/26/2013 INTEGRA LAMINOPLASTY SYSTEM SEASPINE, INC. JEFF BRITTAN
K130883 03/29/2013 SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T SEDECAL SA LUISA GOMEZ DE AGUERO
K123126 03/12/2013 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) SHANGHAI MOTEX HEALTHCARE CO., LTD. JEN KE-MIN
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K130695 03/25/2013 Z5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD WU ZICUI
K130841 03/26/2013 SHOFU BLOCK HC SHOFU DENTAL CORPORATION DAVID P MORAIS
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K130619 03/07/2013 ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K130881 03/29/2013 ACUSON S2000 AND S3000 SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
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K130885 03/29/2013 MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
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K130731 03/18/2013 STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW STABILIZ ORTHOPAEDICS, LLC DOUGLAS L CERYNIK, MD
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K130720 03/18/2013 SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM SYNTHES (USA) PRODUCTS LLC THOMAS SHEA
K130850 03/27/2013 PRIMI AND SECONDI SUPPORT CATHETERS THERMOPEUTIX INC. JASON FORD
K130645 03/11/2013 AQUILION PRIME, V5.00 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
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K130573 03/04/2013 TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF TYBER MEDICAL LLC JEFF TYBER
K130585 03/05/2013 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD. DAVE KIM
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K130703 03/22/2013 VIVORTE BVF VIVORTE, INC STEPHEN J PEOPLES
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K130486 03/01/2013 FUTURABOND UNIVERSAL VOCO GMBH T. GERKENSMEIER
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K130438 03/04/2013 AXLE INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN, M.D.
K130658 03/12/2013 ELIXBO PM545 XBO MEDICAL SYSTEMS CO., LTD JINHONG GUO
K130611 03/11/2013 ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE XERIDIEM MEDICAL DEVICES MICHELLE LOTT
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