FDA 510(k) Decisions During October, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K140938 10/10/2014 OSTOM-I ALERT 11 HEALTH AND TECHNOLOGIES LLC E J SMITH
K140684 10/24/2014 CLINPRO PROPHY POWDER 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K141570 10/31/2014 IMPLANT STUDIO 3SHAPE MEDICAL A/S HANNE NIELSEN
K141160 10/07/2014 A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K141201 10/08/2014 A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K141659 10/09/2014 PRISM ZIRCONIA, ST-98 A & D DENTAL INNOVATIONS YOONHO JUN
K140293 10/31/2014 TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEMS LTD. NISSIM SHAKED
K141912 10/29/2014 AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K140249 10/08/2014 LONG PULSE ND: YAG LASER SYSTEM ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K140619 10/10/2014 MECA XPRESSFISH ADVANDX, INC. RON EISENWINTER
K133360 10/17/2014 AERONEB SOLO; AERONEB SOLO ADAPTER AEROGEN LTD MARTIN CREHAN
K142150 10/29/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K142184 10/16/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K142884 10/28/2014 E-CUBE 12 ALPINION MEDICAL SYSTEMS CO., LTD Donghwan Kim
K142733 10/28/2014 E-CUBE 5 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K142614 10/10/2014 AngioDynamics VenaCure EVLT TreÆ Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc. Teri Juckett
K141865 10/15/2014 DANA ANTHROTRONIX, INC CORINA E LATHAN, PHD, PE
K141522 10/06/2014 APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES APEX MEDICAL CORP. ALAN CHANG
K141742 10/17/2014 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS ARDO MEDICAL AG YARMELA PAVLOVIC
K141339 10/23/2014 ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE ASAHI INTECC CO., LTD. CANDACE CEDERMAN
K140463 10/10/2014 INTEGRA EXTERNAL FIXATION SYSTEM ASCENSION ORTHOPEDIC STEVE BROWN
K131987 10/15/2014 MULTIPULSE HOPLUS ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K142078 10/30/2014 VELASII THERAPY LASER SYSTEM ASPEN LASER SYSTEMS, LLC A. BRAUN HENDERSON
K142441 10/29/2014 cryoICE croablation probe ATRICURE, INC. Jonathan McElwee
K142425 10/27/2014 Uroflowmeter BE TECHNOLOGIES, INC. Edward Belotserkovsky
K142346 10/15/2014 Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland Inc. Anne-Marie Shine
K142170 10/28/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company MONICA E GIGUERE
K141973 10/06/2014 DIODE LASER HAIR REMOVAL SYSTEM BEIJING ANCHORFREE TECHNOLOGY CO., LTD Diana Hong
K133975 10/03/2014 MSA100 PEAK FLOW METER BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD MIKE GU
K133441 10/10/2014 ONESTEP CPR II MULTI-FUNCTION ELECTRODE BIO-DETEK, INC. SHANNON DUHAMEL
K140590 10/30/2014 ASTROGLIDE SENSUAL STRAWBERRY BIOFILM, INC. Sherry Castello
K140120 10/10/2014 EPIC 10 BIOLASE, INC. COLLEEN BOSWELL
K141791 10/09/2014 BIOMET FUSION SYSTEM BIOMET SPINE TED KUHN
K140908 10/02/2014 JUGGERKNOT MINI SOFT ANCHOR BIOMET SPORTS MEDICINE Jared Cooper
K141331 10/27/2014 BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) BIOMET, INC. TRACY BICKEL JOHNSON
K141407 10/27/2014 VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL BIOMET, INC. JULIE GANTENBERG, M.S.
K141326 10/08/2014 NEEDLE VIEW CH SCOPE KITS BIOVISION TECHNOLOGIES, LLC
K140577 10/01/2014 INNESIS PEEK TL CAGE BK MEDITECH CO., LTD. ELAINE DUNCAN
K141335 10/17/2014 EXPEL APD DRAINAGE CATHETER SYSTEM BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K141344 10/17/2014 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K141820 10/21/2014 JAGWIRE HIGH PERFORMANCE GUIDWIRE BOSTON SCIENTIFIC CORP. ALLISON BAILLIE
K141378 10/08/2014 IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation LIZ JOHNSTON
K141584 10/16/2014 ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation THOMAS HIRTE
K140020 10/28/2014 HYPERQ ACS-100 SYSTEM BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. AHAVA STEIN
K142443 10/30/2014 Site-Rite 6 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc Kerrie Hamblin
K142575 10/31/2014 Bard RiteCath Intermittent Urinary Catheter C.R. Bard, Inc. Michele Davis
K142267 10/17/2014 Sherlock 3CG Tip Positioning System Stylet C.R.Bard, Inc. Bryan Stone
K140940 10/27/2014 PROCESS INDICATOR TAPE FOR STEAM STERILIZATION CANADIAN TECHNICAL TAPE, LTD. GARY SOCOLA
K142372 10/30/2014 Pico Way Laser System CANDELA CORPATION Ruthie Amir
K141297 10/03/2014 FORUM GLAUCOMA WORKPLACE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K140581 10/17/2014 CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT CEDIC S.R.L. ROGER GRAY
K142079 10/24/2014 STALIF CTI, STALIF C CENTINEL SPINE, INC. JUSTIN EGGLETON
K142396 10/09/2014 Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests Chemtron Biotech, Inc. Jane Zhang
K133069 10/24/2014 CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES CODENT TECHNICAL INDUSTRY CO., LTD. CHIN-TING WEN
K142193 10/15/2014 COGENT MED-LIF XL COGENT SPINE LLC JUDE PAGANELLI
K132592 10/09/2014 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET COOK, INC. DAVID LEHR
K140754 10/23/2014 COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM COOPER SURGICAL, INC. TIM LOHNES
K140022 10/24/2014 NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT CORK MEDICAL PRODUCTS LLC JON SPEER
K142869 10/30/2014 Premium Surgiclip III COVIDIEN Michael Koczocik
K142364 10/01/2014 Barrx RFA Self Sizing Balloon Catheter Covidien llc Rachel Silva
K142198 10/08/2014 BNX Fine Needle Aspiration System Covidien LLC Saket Bhatt
K142654 10/28/2014 Fortrex 0.035 OTW PTA Balloon Catheter Covidien LLC Rupali Gupta
K141542 10/02/2014 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) Covidien LLC MIA M WARE
K141894 10/06/2014 SHARKCORE FINE NEEDLE BIOPSY SYSTEM COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) Saket Bhatt
K141801 10/16/2014 HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM COVIDIEN, LLC JULIE UNDERDAHL
K141809 10/27/2014 RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM DEFIBTECH, LLC Ed Horton
K141753 10/16/2014 AQUARIUS NASAL FEEDING TUBE DEGANIA SILICONE, LTD. ZOYA LEE
K142517 10/31/2014 SolfVue DELPHINUS MEDICAL TECHNOLOGIES, INC Andrea N Wallen-Gerding
K142574 10/24/2014 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TRACEY HANNON
K140605 10/03/2014 MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC DIMA ITALIA SRL DARIO BASCIU
K140598 10/16/2014 PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC DIMA ITALIA SRL DARIO BASCIU
K140728 10/17/2014 MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR DITRON PRECISION LTD TALI HAZAN
K141623 10/07/2014 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM ECO MEDI GLOVE SDN BHD SURESH KUMAR
K141579 10/17/2014 EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141510 10/07/2014 EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141745 10/31/2014 IQQA-BODYIMAGING SOFTWARE EDDA TECHNOLOGY DANIEL KAMM
K142199 10/29/2014 Ascendra Balloon Aortic Valvaloplasty Catheter EDWARDS LIFESCIENCES Susan Reynolds
K141855 10/08/2014 CLARITY ELEKTA LTD.
K141739 10/07/2014 RESIDUAL LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. REBECCA SHELBURNE
K141347 10/02/2014 EMERGE MEDICAL IM NAIL SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K140467 10/07/2014 FLEX-MT + EMSI CHERITA JAMES
K140472 10/17/2014 BONASTENT TRACHEAL / BRONCHIAL ENDOCHOICE, INC. Bosmat Friedman
K142252 10/17/2014 XprESS Multi-Sinus Dilation Tool ENTELLUS MEDICAL, INC. Karen E. Peterson
K142245 10/29/2014 EpiAccess System EpieP, Inc. Pamela Bunes
K142042 10/21/2014 ERCHONIA SHL ERCHONIA CORPORATION Kevin Walls
K141560 10/23/2014 ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, INC. SUSAN LIN
K141776 10/15/2014 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, INC. PETER CECCHINI
K141456 10/08/2014 THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL FIAGON GMBH DIRK MUCHA
K133225 10/24/2014 E-FIT EF-1280 EMS MACHINE FIT-PRO KFT LTD. RHONDA ALEXANDER, M.S., M.P.A.
K141850 10/27/2014 FLOSPINE PEDICLE SCREW SYSTEM FLOSPINE RICH JANSEN
K141106 10/10/2014 FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES KEVIN ETHERIDGE
K140062 10/03/2014 FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER FSC LABORATORIES, INC. PAUL DRYDEN
K142003 10/21/2014 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K141765 10/03/2014 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC. KATHERINE Y CHOI
K142160 10/10/2014 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K142323 10/10/2014 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System GE MEDICAL SYSTEMS ISRAEL LTD. Bryan Behn
K133245 10/08/2014 GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM GENESYS SPINE WILLIAM W SOWERS
K141700 10/31/2014 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. KAITLYNN MIN
K142534 10/03/2014 HyProCure II Graham Medical Technologies, L.L.C. dba GraMedica ANGELA RECCHIA
K142088 10/31/2014 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K131925 10/10/2014 HS NOTA H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K142063 10/28/2014 #8C RENEGADE DENTAL HANDPIECE HANDPIECE CLUB, LLC TINA WU
K141125 10/23/2014 U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE HANDPIECE HEADQUARTERS TINA STEFFANIE-OAK
K142280 10/16/2014 Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K141869 10/10/2014 QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT HEMEDEX INCORPORATED DEAN HONKONEN
K142618 10/16/2014 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System Hitachi Aloka Medical America, Inc. Angela Van Arsdale
K142037 10/10/2014 QUANTRA HOLOGIC, INC. CATHERINE WILLIAMS
K141242 10/17/2014 GLIDE DEVICE HOME SKINOVATIONS LTD. AHAVA STEIN
K140929 10/17/2014 Z1 CPAP SYSTEM HUMAN DESIGN MEDICAL, LLC MAUREEN O'CONNELL
K141713 10/28/2014 SMARTGRAFT 200 SYSTEM INGENERON, INC. ANITA KADALA
K133810 10/30/2014 VC150 VITAL SIGNS MONITOR INNOKAS YHTYMA Tiina Kotipalo
K140805 10/09/2014 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K133390 10/16/2014 NDX DORSAL APPLIANCE INSTITUTE FOR QUALITY RESOURCE MANAGEMENT LEAH AMIR, MS, MHA
K142414 10/30/2014 Miltex N-Tralig Intraligamentary Syringe INTEGRA LIFESCIENCES CORPORATION Judith E. O'Grady
K131487 10/08/2014 FLUOR PROTECTOR S IVOCLAR VIVADENT AG DONNA M HARTNETT
K142484 10/31/2014 Sternal Closure System JACE Medical LLC Justin May
K142460 10/01/2014 EXPEDIUM Spine System/Synapse System JOHNSON AND JOHNSON Jaclyn Porsolt
K142536 10/03/2014 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K142540 10/03/2014 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) JVC KENWOOD CORPORATION Tsukasa Tashiro
K142556 10/23/2014 Flexible Video-Uretero-Choledochoscope System KARL STORZ ENDOSCOPY-AMERICA, INC. Mike Samuels
K140052 10/30/2014 J2I IMPLANT SYSTEM KJ MEDITECH CO., LTD. Priscilla Chung
K140051 10/30/2014 KJ EXTERNAL IMPLANT SYSTEM KJ MEDITECH CO., LTD. Priscilla Chung
K141539 10/29/2014 KUBTEC X250 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K141221 10/28/2014 LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR LARES RESEARCH, INC. JASON ORGAIN
K141908 10/22/2014 DUAL SWITCH LASER ENGINEERING, INC. LAURIE DOBBS
K142660 10/17/2014 Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. Xiang (Vic) Zhang
K142359 10/23/2014 Vasc Band hemostat Lepu Medical Technology (Beijing) Co., LTD Kim Xiangdan
K131737 10/23/2014 SUPERNOVA C5 MRI SYSTEM LIAONING KAMPO MEDICAL SYSTEM CO., LTD. SHAO KAI
K141723 10/22/2014 UPCERA COLORING LIQUID (I AND II ) LIAONING UPCERA CO.,LTD CHARLES SHEN
K141724 10/22/2014 UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK LIAONING UPCERA CO.,LTD CHARLES SHEN
K140236 10/20/2014 AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE, INC RANDY LEWIS
K141658 10/22/2014 LIGHT SCALPEL LIGHT SCALPEL LLC DAVID WALTERS
K142757 10/23/2014 LiNA PowerBlade Plus HC LiNA Medical ApS Louisa Memborg
K142538 10/06/2014 LiNA SafeAir Smoke Pencil LINA MEDICAL APS Louisa Memborg
K133849 10/22/2014 VANTERA CLINICAL ANALYZER LIPOSCIENCE SUZETTE WARNER
K140647 10/24/2014 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) LUMINEX MOLECULAR DIAGNOSTICS, INC. Tina Ip
K140927 10/24/2014 UNIVERSAL NAVIGATION INSTRUMENTS MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K134009 10/15/2014 UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL MEDTEK LIGHTING SUSAN ANTHONEY-DE WET
K141704 10/06/2014 NOVASHIELD INJECTABLE NASAL PACKING AND STENT MEDTRONIC INC. RISHI SINHA
K142847 10/27/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANCK USA, INC. LAVEEDA LEFLORE
K142450 10/01/2014 DIVERGENCE Anterior Cervical Fusion System MEDTRONIC SOFAMOR DANEK USA, INC Shweta Sharma
K141604 10/21/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K142784 10/24/2014 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Medtronic, Inc Lisa Stone
K133157 10/23/2014 TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 MEDTRONIC, INC. JESSICA SIXBERRY
K142096 10/17/2014 T-PIECE RESUSCITATOR MERCURY MEDICAL PAUL DRYDEN
K140251 10/22/2014 UNIVERSAL DIGITAL INTERFACE 2, UDI 2 MERIDIAN MEDICAL SYSTEMS, LLC LARRY CORNELL
K142636 10/17/2014 Merit 10mL Syringe Merit Medical Systems, Inc. Mridi Kumathe
K140543 10/16/2014 PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K141491 10/22/2014 SOLITAIRE 2 REVASCULARIZATION DEVICE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR LARRY BOUCHER
K142014 10/10/2014 SOFIA DISTAL ACCESS CATHETER MICROVENTION, INC. Naomi Gong
K141603 10/22/2014 Ultra Silver Dressings MILLIKEN HEALTHCARE PRODUCTS, LLC GORDON MACFARLANE
K133040 10/07/2014 LED CURING LIGHT MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K142033 10/10/2014 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPERE,INC. NOAH LERMER
K140530 10/02/2014 Electro Auricular Device NAVIGANT CONSULTING, INC. COLLEEN HITTLE
K142616 10/14/2014 PICC Maximal Barrier Nursing Kit NAVILYST MEDICAL, INC. WANDA CARPINELLLA
K141660 10/31/2014 NAWALUTION SKIN AND WOUND CLEANSER NAWA HEILMITTEL GMBH ALLYSON B MULLEN
K142084 10/28/2014 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. JANE RICUPERO
K142275 10/07/2014 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens NEO VISION CO., LTD. Kyung Hwa Kim
K141731 10/24/2014 NEPHROS DSU-H, NEPHROS SSU-H NEPHROS, INC. JAMES SUMMERTON
K142286 10/31/2014 NS3000 Holmium Laser System New Star Lasers, Inc. Natalie Vollrath
K142220 10/17/2014 Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K141207 10/31/2014 NOVABONE BIOACTIVE STRIP NovaBone Products, LLC Lisa Simpson
K132853 10/30/2014 NOVAPACS NOVARAD CORP. AMY HOFFMAN
K140319 10/09/2014 COROENT TI-C SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K142050 10/29/2014 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM NUVASIVE, INCORPORATED MICHELLE CHEUNG
K141759 10/24/2014 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS OAK RIDGE PRODUCTS, LLC CONOR J O'MALLEY
K140470 10/15/2014 OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER OBERON GMBH FIBER TECHNOLOGIES ARMIN KAUS
K141502 10/03/2014 HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. Howard Schrayer
K142727 10/24/2014 CrossCLIP Implant System OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems Vernon Hartdegen
K141842 10/06/2014 STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID C KERR
K142090 10/29/2014 REBOSSIS ORTHOREBIRTH CO., LTD. KEVIN A.THOMAS
K140309 10/03/2014 CRANIOPLUG OSSDSIGN AB DAVID WEISSBURG
K141200 10/02/2014 PADI-LOCK PADI-LOCK, LLC MARIA GRIFFIN
K140023 10/16/2014 ELEVATION PDG PRODUCT DESIGN GROUP, INC. EDWARD A KROLL
K140025 10/15/2014 AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation TONY HSU
K142698 10/23/2014 PerkinElmer, XRpad 4343 F MED Flat Panel Detector PerkinElmer, Inc Dawn Spooner
K140493 10/30/2014 ELIA SCL-70S IMMUNOASSAY PHADIA GMBH MARTIN R MANN
K140225 10/27/2014 ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO PHADIA US INC. MARTIN MANN
K142708 10/22/2014 VERADIUS UNITY PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jeanette Becker
K142027 10/07/2014 888 WNLE POWERED WHEELCHAIR PIHSIANG MACHINERY MFG. CO., LTD. DAVID LIN
K141600 10/17/2014 NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I SARAH MCINTYRE
K141816 10/23/2014 HEMOPORE Polyganics BV BETTY IJMKER
K142302 10/02/2014 BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis Polymer Technology Systems, Inc. Jack Rogers
K141211 10/22/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS PRISMATIK DENTALCRAFT, INC. Armin Zehtabchi
K132771 10/28/2014 KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS QINGDAO KINGSTON MEDICAL DEVICES LTD WU HANHUA
K141931 10/09/2014 LYRA ADENOVIRUS ASSAY QUIDEL CORPORATION Ronald H Lollar
K141927 10/09/2014 LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION Ronald H Lollar
K141743 10/03/2014 FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT RADIOLOGY SOLUTIONS LLC DANIEL KAMM, P.E.
K141881 10/31/2014 RAPIDRESULTS RAMSOFT, INC. LELY LAM-HONG
K141860 10/23/2014 RAYSTATION RAYSEARCH LABORATORIES AB DAVID HEDFORS
K142304 10/03/2014 Viberect Penile Vibratory Stimulation Device REFLEXONIC, LLC Kambiz Tajkarimi
K141954 10/15/2014 XCEL 455 SLIT LAMP REICHERT, INC. THOMAS M HECKMANN
K133990 10/09/2014 IEVA REHABILITATIVE POSITIONAL DEVICE REMENDIUM LABS, LLC YOLANDA LORIE
K142095 10/15/2014 RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton
K141175 10/24/2014 RENOVOCATH RC120 RENOVORX, INC. RON S WARREN
K142755 10/23/2014 Siemens 3.0 Blanket Array Coil RESONANCE INNOVATIONS LLC Randall Jones
K140268 10/20/2014 SIMPLE T YOUTH NASAL MASK RESPIRONICS, INC. COLLEEN WITT
K141664 10/02/2014 SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION REXAM HEALTHCARE BEATRICE GRAND DEMARS
K141426 10/17/2014 ELECSYS FOLATE III Roche Diagnostics KELLI TURNER
K142133 10/24/2014 ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics Sarah Baumann
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