FDA 510(k) Applications Received During June, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K121878 06/28/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES MEDTRONIC INC. KARI CHRISTIANSON
K121767 06/15/2012 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE MEDTRONIC INC. MARY E DONLIN
K121741 06/15/2012 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) 4-WEB, INC. RICH JANSEN, PHARM, D.
K121876 06/27/2012 VERTECEM II CEMENT KIT AAP BIOMATERIALS GMBH VOLKER STIRNAL
K121721 06/12/2012 LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) ABBOTT MEDICAL OPTICS INC ABBAS M BOHRA
K121748 06/14/2012 THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K121803 06/19/2012 INTRAVASCULAR ADMINISTRATION SET ACTA MEDICAL LLC JOHN BREWER
K121879 06/28/2012 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEMS JULIE TOM WING
K121801 06/19/2012 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC LISA BOYLE
K121611 06/01/2012 AMPLATZER TORQVUE FX AGA MEDICAL CORPORATION SHERRY KOLLMANN
K121712 06/11/2012 AIRSTRIP RPM FOR LIFENET CONSULT AIRSTRIP TECHNOLOGIES, INC. ROBERT A MILLER
K121871 06/27/2012 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP ROBERT ANDREW MILLER
K121662 06/05/2012 VECTTOR VT-200 ALAN NEUROMEDICAL TECHNOLOGIES LLC DONALD A RHODES
K121905 06/29/2012 ALERE PBP2A TEST ALERE SCARBOROUGH, INC ANGELA DRYSDALE
K121888 06/28/2012 E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K121729 06/12/2012 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD YUCHI CHU
K121892 06/29/2012 PHANTOM PLUS CERAMIC CAGE SYSTEM AMEDICA CORP. ROBERT M WOLFARTH
K121805 06/19/2012 AMS LARGE PORE POLYPROPHLENE MESH AMERICAN MEDICAL SYSTEMS RENEE MELLUM
K121612 06/28/2012 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION AMERICAN MEDICAL SYSTEMS NGOC LINH PHAM LATCHMAN
K121641 06/04/2012 MINIARC PRO SINGLE-INCISION SLING SYSTEM AMERICAN MEDICAL SYSTEMS RENEE MELLUM
K121822 06/21/2012 DELICOT AMERICAN SURGICAL COMPANY, LLC ERIK PIASIO
K121697 06/07/2012 FINGERTIP PULSE OXIMETER ANDON HEALTH CO., LTD LIU YI
K121642 06/04/2012 WIZARD 230 NASAL PILOW MASK APEX MEDICAL CORP. FRANK LIN
K121659 06/05/2012 BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) ARCOS, INC. CHRIS MEADOR
K121826 06/26/2012 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K121661 06/05/2012 EZ-ASSIST-FILL ASSIST FILL, LLC GRIFFIN
K121810 06/20/2012 OSSEOSPEED ANGLED ABUTMENT EV ASTRA TECH AB LINDA K SCHULZ
K121793 06/19/2012 AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON AUDIFON-USA INC. JANE E PERRONE
K121873 06/27/2012 AVINENT DENTAL IMPLANT SYSTEM AVINENT IMPLANT SYSTEM, S.L. ANNA CORTINA
K121842 06/25/2012 ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K121846 06/25/2012 CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K121786 06/25/2012 DYMAXEON SPINE SYSTEM B2B SPINE PTY LTD JUSTIN EGGLETON
K121788 06/18/2012 NIO 5MP BARCO NV LIEVEN DE WANDEL
K121634 06/04/2012 INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K121655 06/05/2012 BD ALCOHOL SWAB BECTON DICKINSON & CO. AVITAL LAKES
K121797 06/19/2012 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K121633 06/04/2012 BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY GREGORY P PAYNE
K121854 06/25/2012 SYSTEM, X-RAY, STATIONARY BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO., LTD DIANA HONG
K121794 06/19/2012 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD, DIAGNOSTICS GRP. SUZANNE PARSONS
K121787 06/18/2012 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K121735 06/13/2012 FIBER DISK AND BLOCK PERMANENT, TRINIA BIOLOREN SRL RATTI ANDREA
K121825 06/21/2012 CS-MAG II BIOMAGNETIK-PARK GMBH THOMAS WEBER
K121773 06/18/2012 NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE BIOMERICS EMILY MADSEN
K121874 06/27/2012 G7 ACETABULAR SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K121589 06/11/2012 BIOMET MICROFIXATION FACIAL PLATING SYSTEM BIOMET MICROFIXATION LAUREN JASPER
K121624 06/15/2012 BIOMET MICROFIXATION NEURO PLATING SYSTEM BIOMET MICROFIXATION SHERYL MALMBERG
K121302 06/13/2012 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION SHERYL MALMBERG
K121754 06/14/2012 BLUE SUI SLING BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K121694 06/07/2012 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. HOLLY RAMIREZ
K121667 06/06/2012 NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) BOSTON SCIENTIFIC CORP. LAURA J LIND
K121614 06/01/2012 NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K121774 06/18/2012 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. BETH TOROK
K121745 06/15/2012 MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K121856 06/26/2012 ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION C.R. BARD, INC. ERIN FOX
K121768 06/15/2012 COSENSE CAPNIA, INC. JULIE BLACKLOCK
K121897 06/29/2012 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K121849 06/25/2012 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE CAREFUSION JOY GREIDANUS
K121653 06/05/2012 INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS CARL ZEISS MEDITEC, INC. SARAH HARRINGTON
K121710 06/11/2012 XPERT CT/NG CEPHEID RUSSEL K ENNS
K121758 06/15/2012 CERNER FETALINK+(VERSION1.0) CERNER CORP. SHELLEY S LOOBY
K121867 06/26/2012 SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS CHISON MEDICAL IMAGING CO., LTD.
K121850 06/25/2012 CHOICE SPINE FIXATION SYSTEM CHOICE SPINE, LP KIM FINCH
K121669 06/06/2012 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K121683 06/07/2012 ACCULIF TL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K121776 06/18/2012 AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE CODMAN & SHURTLEFF, INC. JOAN BARTLE
K121833 06/22/2012 OSTOMY IRRIGATION SET COLOPLAST A/S TIM CRABTREE
K121621 06/01/2012 SOLOCEM COLTENE/WHALEDENT AG SILKE WALLASCHEK
K121759 06/15/2012 CONE-TROL LIQUID CHEMISTRY CONTROLS CONE BIOPRODUCTS WILL CONE
K121728 06/12/2012 TIGER SPINE SYSTEM CORELINK LLC J.D. WEBB
K121791 06/19/2012 ZOU ANTERIOR LUMBAR PLATE SYSTEM CORELINK LLC JUSTIN EGGLETON
K121665 06/06/2012 BENCOX FORET & BENCOX DELTA CORENTEC CO., LTD J.S. DANIEL
K121819 06/21/2012 SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC. CHRISTOPHER FREDRIC
K121806 06/20/2012 BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE COVIDIEN ELIZABETH MALO
K121795 06/19/2012 CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT CYTOPHIL INC BILL HUBBARD
K121718 06/11/2012 A-V FOOT PUMP DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. DORIS DONG
K121880 06/28/2012 DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID DANVILLE MATERIALS, INC. LINDSAY TILTON
K121853 06/25/2012 DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
DEN120016 06/15/2012 DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION Roger Leroux
K121698 06/08/2012 NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN DENTSPLY INTERNATIONAL INC. HELEN LEWIS
K121617 06/01/2012 SENSICARDIAC DIACOUSTIC MEDICAL (PTY) YOLANDA SMITH
K121862 06/26/2012 REX ANTERIOR CERVICAL PLATE SYSTEM DIO MEDICAL CO., LTD. APRIL LEE
K121620 06/01/2012 ULTRASONIC SURGERY DMETEC CO., LTD. DANIEL NAM
K121881 06/26/2012 DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. CURTIS JENSEN
K121656 06/05/2012 GEMINI LITHOTRIPTER DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121886 06/28/2012 SAVINA 300 SAVINA 300, COUNTRY VARIANTS DRAEGER MEDICAL GMBH BETH ZIS
K121845 06/25/2012 SDX SYSTEM DYN'R SAS TIM LAWTON
K121885 06/28/2012 EARLYSENSE CENTRAL DISPLAY SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K121663 06/05/2012 CLARITY ELEKTA LTD. GEORGE PAPAGIANNIS
K121835 06/22/2012 DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE ENCORE MEDICAL, L.P. MICHAELA NORRIS
K121727 06/12/2012 MOVATION KNEE SYSTEM ENCORE MEDICAL, L.P. WILLIAM GARZON
K121628 06/04/2012 EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM ("EPI MINI") EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD KARL M NOBERT
K121695 06/07/2012 ERCHONIA ZERONA ERCHONIA CORPORATION KEVIN WALLS
K121690 06/07/2012 ETCHONIA ZERONA ARMS ERCHONIA CORPORATION KEVIN WALLS
K121650 06/05/2012 S-SCAN ESAOTE, S.P.A. ALLISON SCOTT
K121600 06/01/2012 ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K121877 06/28/2012 GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES EXACTECH, INC. VLADISLAVA ZAITSEVA
K121684 06/07/2012 NOVATION LPI PRIME FEMORAL STEM EXACTECH, INC. VLADISLAVA ZAITSEVA
K121857 06/26/2012 FEMMYCYCLE FEMCAP INCORPORATED ALBERT REGO
K121860 06/26/2012 ESA615 FLUKE BIOMEDICAL JOHN NELSON
K121722 06/12/2012 ESA620 ELECTRICAL SAFETY ANALYZER FLUKE BIOMEDICAL JOHN NELSON
K121706 06/08/2012 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM FORA CARE INC. PINJUNG CHEN
K121613 06/21/2012 AGILIA INFUSION SYSTEM FRESENIUS KABI AG CHERYL ROSCHER
K121599 06/01/2012 CRIT-LINE CLIP (CLIC) FRESENIUS MEDICAL CARE-NORTH AMERICA DENISE OPPERMANN
K121674 06/11/2012 ASPIRE HD PLUS, ASPIRE HD-S FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K121827 06/21/2012 GSI VIEWER WITH VUE OPTION GE MEDICAL SYSTEMS SCS HELEN PENG
K121676 06/07/2012 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT GE MEDICAL SYSTEMS, LLC SHASHIDHAR CS
K121762 06/15/2012 CARDIAC VX GE MEDICAL SYSTEMS, LLC MICHELLE HUETTNER
K121732 06/13/2012 CANOPY LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL INC. SARAH MARIE FITZGERALD
K121908 06/29/2012 SAFETY INFUSION SET GREINER BIO-ONE NORTH AMERICA, INC. JUDITH SMITH
K121678 06/07/2012 DTAD GYRUS ACMI, INC. DOLAN MILLS
K121858 06/26/2012 THE ABLATION SYSTEM HALT MEDICAL INC. CLARISA TATE
K121770 06/15/2012 HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER HEADSTAR MEDICAL PRODUCTS CO., LTD GLORIA CHEN
K121757 06/15/2012 HEALTHMATEFOREVER HEALTHMATE INTERNATIONAL, LLC MEI DODSON
K121868 06/26/2012 MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K121719 06/11/2012 SM TENS & PMS HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED DORIS DONG
K121335 06/12/2012 G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE HUTCHINSON SANTE S.N.C. RAFFI KRIKORIAN
K121654 06/05/2012 AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION I-SENS, INC. HYUN JOON OH
K121682 06/07/2012 ACTIVE SCREW BONE SCREW INTELLIGENT IMPLANT SYSTEMS, LLC MICHAEL J NUTT
K121847 06/25/2012 TITAN INTERACOUSTICS A/S ERIK NIELSEN
K121747 06/14/2012 FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS INTERSURGICAL INCORPORATED MICHAEL ZALEWSKI
K121769 06/15/2012 DENTOCORE/DENTOCORE BODY ITENA CLINICAL LOUIS- PAUL MARIN
K121804 06/19/2012 PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM ITENA CLINICAL LOUIS PAUL MARIN
K121817 06/20/2012 VCARE A IVT MEDICAL LTD ELI ORBACH
K121808 06/21/2012 CASIAN, 3.5/4.5 CONNECTORS K2M, INC. NANCY GIEZEN
K121630 06/04/2012 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K121755 06/15/2012 CUSTOM CRANIOFACIAL IMPLANT (CCI) KELYNIAM GLOBAL, INC. NICHOLAS BREAULT
K121606 06/01/2012 RESORB-X G KLS-MARTIN L.P. JENNIFER DAMATO
K121824 06/21/2012 ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 LASCOD SPA BLIX WINSTON
K121838 06/22/2012 LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM LIEBEL-FLARSHEIM CRAIG BUEHLER
K121890 06/28/2012 GENESYS PRESSFT SUTURE ANCHOR LINVATEC CORPORATION D/B/A CONMED LINVATEC LORNA K LINVILLE
K121894 06/29/2012 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K121640 06/04/2012 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K121752 06/15/2012 AVIE TOTAL HB TEST SYSTEM MEC DYNAMICS CORP EMMANUAL MPOCK
K121703 06/08/2012 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MEDI-KHAN USA, INC KACHI ENYINNA
K121848 06/26/2012 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM MEDICAL COMPONENTS INC JEAN CALLOW
K121716 06/11/2012 TBS INSIGHT MEDIMAPS GROUP SA CHRISTOPHE LELONG
K121760 06/15/2012 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K121680 06/07/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K121764 06/15/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BRAD SHEALS
K121670 06/06/2012 MEDYSSEY CANNULATED PEDICLE SCREW MEDYSSEY CO., LTD. MICHAEL KVITNITSKY
K121832 06/22/2012 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. CASEY HUGHES
K121785 06/18/2012 SCEPTER C OCCLUSION BALLOON CATHETER MICRO VENTION, INC. NAOMI GONG
K121901 06/29/2012 TI-MAX Z45 NAKANISHI, INC. FUMIAKI KANAI
DEN120014 06/15/2012 VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) NANOSPHERE, INC MARK DEL VECCHIO
K121816 06/20/2012 SENSUS ELECTRODE NEUROMETRIX, INC. RAINER MAAS
K121792 06/19/2012 NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. CHARLES MACK
K121891 06/29/2012 NEWPORT AURA VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K121622 06/01/2012 NIDEK RS-3000 NIDEK CO., LTD. LENA SATTLER
K121859 06/26/2012 TYSHAK NUCLEUS NUMED, INC. NICHELLE LAFLESH
K121837 06/22/2012 NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM NUVASIVE, INC. CYNTHIA ADAMS
K121619 06/01/2012 NUVASIVE POLYAXIAL SPINAL SCREWS NUVASIVE, INC. ELIAS KETCHUM
K121815 06/20/2012 NUVASIVE SAGE LATERAL PLATE SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K121604 06/01/2012 ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT OBP CORPORATION JASON SWIFT
K121701 06/08/2012 SYSTEMS INTEGRATION OLYMPUS MEDICAL SYSTEMS CORP. KATHY ANDERSON
K121739 06/13/2012 IVUE WITH NORMATIVE DATABASE OPTOVUE, INC. AZIMUN JAMAL
K121702 06/08/2012 ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE ORTHO MEDICAL DAVID ROTHKOPF
K121608 06/01/2012 VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS, INC. ERIC SCHAEFFER
K121649 06/05/2012 CONSTRUX MINI PEEK TI SPACER SYSTEM ORTHOFIX NATALIA VOLOSEN
K121658 06/05/2012 ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) ORTHOFIX INC. ALLY BADUEL
K121843 06/25/2012 NP-CAST ABUTMENT SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K121818 06/20/2012 OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE OXFORD PERFORMANCE MATERIALS LEIGH AYRES
K121707 06/11/2012 LEW MDI O-BALL COLLARED IMPLANT, PARK DENTAL RESEARCH CORP. RONALD BULARD
K121864 06/26/2012 PERKINELMER 226 SAMPLE COLLECTION DEVICES PERKINELMER, INC. KAY A TAYLOR
K121638 06/04/2012 ST80I STRESS TEST SYSTEM PHILIPS HEALTHCARE GRETAL LUMLEY
K121772 06/15/2012 ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FRANS JACOBS
K121781 06/18/2012 ECHONAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FRANS JACOBS
K121733 06/13/2012 INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC REBECCA K PINE
K121725 06/12/2012 PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K121800 06/19/2012 POINT 500 HD POINT500C HD POINTNIX CO., LTD JIGAR SHAH
K121688 06/07/2012 MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. KATHLEEN DRAGOVICH
K121657 06/05/2012 PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR PROTON SYSTEMS MIKE BEGALA
K121713 06/11/2012 PMT BONE SCREWS PROVIDENCE MEDICAL TECHNOLOGY, INC. GLEN MANGSETH
K121898 06/29/2012 STAY FRESH SKIN FOLD MANAGEMENT TEXTILE QUICK-MED TECHNOLOGIES, INC. MARY MCNAMARA-CULLINANE
K121696 06/07/2012 WIRELESS THERMOMETER RALING MEDICAL COMPANY WU WEI
K121603 06/01/2012 RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K121746 06/14/2012 RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K121609 06/01/2012 ASTHMAPOLIS SYSTEM RECIPROCAL LABS CORPORATION INGER L COUTURE
K121705 06/08/2012 GEO RESMED LTD. JIM CASSI
K121623 06/01/2012 BIPAP A 40 VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ELAINE LARKIN
K121631 06/04/2012 SIMPLE T NASAL MASK RESPIRONICS, INC. MICHELLE BRINKER
K121724 06/12/2012 ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 RICHARD WOLF MEDICAL INSTRUMENTS CORP. RON HASELHORST
K121679 06/07/2012 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS MIKE FLIS
K121895 06/29/2012 ELECSYS HSV-2 IGG IMMUNOASSAY ROCHE DIAGNOSTICS K. COLLEEN ADAMS
K121610 06/01/2012 COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY ROCHE DIAGNOSTICS OPERATIONS SUSAN HOLLANDBECK
K121763 06/19/2012 MULTICROSS SUPPORT CATHETER ROXWOOD MEDICAL, INC. MEHRDAD FARHANGNIA
K121693 06/14/2012 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) SAPPHIRE MEDICAL GROUP, INC ROBERT POGGIE
K121734 06/13/2012 PLATO MICROCATH 27 MICROCATHETER SCIENTIA VASCULAR , LLC SHARON ROCKWELL
K121811 06/20/2012 POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES SHEN WEI (USA), INC. ALBERT LI
K121749 06/14/2012 VERACIA SHOFU DENTAL CORPORATION DAVID P MORAIS
K121672 06/06/2012 AFT PROXIMAL HUMERUS FRACTURE PLATE SHOULDER OPTIONS, INC. JOHN KAPITAN
K121907 06/29/2012 DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K121699 06/08/2012 ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K121807 06/20/2012 V5MS TRANSDUCER SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K121646 06/05/2012 ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP SHELLY PEARCE
K121814 06/20/2012 ENCORE TONGUE SUSPENSION SYSTEM SIESTA MEDICAL, INC. MICHAEL KOLBER
K121632 06/12/2012 COMFORT EZ SIMPLE DIAGNOSTICS, INC. DANIEL KAMM
K121692 06/07/2012 MINIME 2 NASAL MASK SLEEPNET CORPORATION PAUL DRYDEN
K121904 06/29/2012 GYNECOLOGY STERILIZATION TRAY SMITH & NEPHEW INC., ENDOSCOPY DIVISION JANICE HASELTON
K121627 06/04/2012 SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM SMITH & NEPHEW, INC. NATALIE P WILLIAMS
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