FDA 510(k) Applications Received During April, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151144 04/29/2015 SuPro 100 3M DEUTSCHLAND GMBH DESI W. SOEGIARTO
K150974 04/13/2015 aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K151014 04/16/2015 Aura DR 43C-AG flat panel detector ABYZR CO., LTD JOHN LIM
K150873 04/01/2015 CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System ACCURAY INCORPORATED Shweta Kaushik
K150866 04/01/2015 SURGISEAL Topical Skin Adhesvie ADHEZION BIOMEDICAL, LLC TRACY LOFGREN
K151056 04/20/2015 Aesculap T-Space PEEK and XP Spinal System AESCULAP IMPLANT SYSTEMS, LLC LISA M. BOYLE
K151097 04/24/2015 Active Breathing Coordinator AKTINA MEDICAL CORPORATION TONY SPACCAROTELLA
K150976 04/13/2015 Collage ANATOMAGE INC. SEAN XU
K150924 04/06/2015 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Sut ANCHOR INNOVATION MEDICAL (A.I.M.) CARY STALNECKER
K151112 04/28/2015 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design ANGIOTECH HILARY WELLS
K151153 04/30/2015 Pirouette 018 ARRAVASC LIMITED MAIREAD MCCAFFREY
K151078 04/22/2015 Arthrex RetroFusion Screw ARTHREX, INC. DAVID L ROGERS
K151103 04/24/2015 ASAHI Corsair Microcatheter ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K150996 04/15/2015 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC. Brittany Lowe
K151102 04/24/2015 Bausch + Lomb Injector System Bausch & Lomb, Inc. Joyce Zhong
K150860 04/01/2015 Nitroglycerin Sets with DUO-VENT Spike BAXTER HEALTHCARE CORPORATION DHIRAJ BIZZUL
K151009 04/15/2015 Nexus Suture BAYLIS MEDICAL COMPANY INC. Meghal Khakhar
K150953 04/09/2015 Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC BIO COMPRESSION SYSTEMS, INC. Barbara J Whitman
K151064 04/20/2015 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System BIOMET SPINE Alexandra Beck
K150867 04/01/2015 Affixus Tibial Nailing System BIOMET, INC. SUZANA OTANO
K151040 04/20/2015 Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer BIOMETRIX LTD. Zoya Lee
K150951 04/09/2015 aeris Balloon Dialation Catheter Bryan Medical , Inc. ANDY BLACK
K151054 04/20/2015 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K151107 04/27/2015 CoSense ETCO Monitor Capnia Inc KRISTEN YEN
K151071 04/21/2015 SmartLinx Vitals Plus Patient Monitoring System CAPSULE TECHNOLOGIE SAS PETER KELLEY
K151116 04/27/2015 CapLOX II/TowerLOX Pedicle Screw System CAPTIVA SPINE TAMALA WAMPLER
K151010 04/15/2015 Piccolo Composite Nailing System CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K150990 04/15/2015 ECVUE Mapping System CardioInsight Technologies, Inc. Christina V Vacca
K150929 04/06/2015 CareView 1500Cw X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. YULING DING
K150977 04/13/2015 Optical Coherence Tomography CARL ZEISS MEDITEC INC MANDY AMBRECHT
K151068 04/21/2015 SureLock W Suture Anchor CAYENNE MEDICAL, INC SHIMA HASHEMIAN
K151057 04/20/2015 WASTON Metallic Bone Plate and Screw Systems CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD Jack Lu
K150861 04/01/2015 QBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. QIFEI LIU
K150886 04/02/2015 Trojan Riviera Personal Lubricant CHURCH & DWIGHT CO., INC. LISA BURNS
K150927 04/06/2015 Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff COLOPLAST A/S LEEANNE SWIRIDOW
K150935 04/07/2015 SpeediCath Compact Eve COLOPLAST A/S Meg Daniel
K151037 04/20/2015 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle CONMED CORPORATION NYROBIA FREEMAN
K150970 04/13/2015 Coda LP Balloon Catheter COOK INCORPORATED Chad Schulenburg
K150892 04/02/2015 CorPath 200 System CORINDUS, INC. Milind Gramopadhye
K150891 04/02/2015 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System Covidien LLC( Formerly Beacon Endoscopic Corp.) Saket Bhatt
K150920 04/06/2015 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K151088 04/23/2015 DMRC Bulk Fill DANVILLE MATERIALS, LLC DONG HUA
K151149 04/30/2015 Ready-Fit DENTEK ORAL CARE, INC. LINDA GILES
K150862 04/01/2015 DePuy Actis Duofox Hip Prosthesis DEPUY ORTHOPAEDICS, INC. CORRENE RAMY
K150879 04/01/2015 LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers DiaSorin Inc. John Walter
K151006 04/15/2015 EarlySense Central Display Station (CDS) EARLYSENSE LTD. DALIA ARGAMAN
K150949 04/08/2015 FibroScan ECHOSENS CELINE FOURNIER
K151038 04/20/2015 EPX-Series Mobile X-ray System ECOTRON CO.,LTD SANG BONG LEE
K150999 04/15/2015 Acclarix Diagnostic Ultrasound System EDAN INSTRUMENTS, INC. QUEENA CHEN
K150901 04/03/2015 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express EDAN INSTRUMENTS, INC. Queena Chen
K150882 04/02/2015 Edwards Suture Fastening System EDWARDS LIFESCIENCES, LLC. NINA BROOKE
K150906 04/03/2015 ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh EHICON INC. SUSAN LIN
K151113 04/27/2015 ELITech Clinical Systems CALCIUM ARSENAZO ELITechGroup Valerie Gourdon
K150907 04/03/2015 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra Ellipse A/S Ole Kofod
K150885 04/02/2015 MAGEC 2 Spinal Bracing and Distraction System Ellipse Technologies, Incorporated REBECCA SHELBURNE
K151131 04/28/2015 PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated Rebecca Shelburne
K151041 04/20/2015 ERBECRYO 2 Cryosurgical Unit with accessories ERBE USA, INC. John Tartal
K151061 04/20/2015 Cornea Cold EUROBIO Marie-Claude Amoureux
K150890 04/02/2015 Exactech Optetrak Logic CC EXACTECH, INC. PATRICK HUGHES
K150883 04/02/2015 HyaloGYN Vaginal Hydrating Gel FIDIA FARMACEUTICI SPA Dr. Giuseppina Lo Castro
K150900 04/03/2015 Flexicare Heated Wire Breathing Systems FLEXICARE MEDICAL LTD. Joel Biddle
K150962 04/10/2015 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack FOCUS DIAGNOSTICS SHARON YOUNG
K151028 04/17/2015 LOGIQ e GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K150998 04/15/2015 HEARTWAY Power Mobility Scooter HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K150987 04/14/2015 HEARTWAY Power Mobility Scooter, BRIO S19 HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K150933 04/06/2015 iBond Universal & iBond Ceramic Primer Heraeus Kulzer LLC, Mitsui Chemicals Group Jamie Cleveland
K151015 04/16/2015 ECHELON Oval V 5.0 MRI System HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K151132 04/28/2015 PROBEAT-V Hitachi, Ltd.,Health Care Company Naoya Nishimura
K150925 04/06/2015 Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set Immunalysis Corporation Joseph Ginete
K150913 04/06/2015 INCITE ANCHORED CERVICAL INTERBODY DEVICE INCITE INNOVATION JOHN KIRWAN
K150954 04/09/2015 Elite L Expandable Lumbar Fusion System INNOVA SPINAL TECHNOLOGIES, LLC ARMANDO VARELA
K151146 04/29/2015 N-Force Fixation System INNOVISION, INC. KEITH RUSSELL
K151027 04/17/2015 zensor system INTELESENS LIMITED PATRICIA PEPPER
K150965 04/10/2015 LeForte System II Jeil Medical Corporation Jieun KIM
K150971 04/13/2015 Zekang Self-adhesive Electrode Jiangsu Zekang Medical Technology Co., Ltd Doris Dong
K151017 04/16/2015 JMS Harmony A.V. Fistula Needle Set JMS NORTH AMERICA CORPORATION SHO HOSOKI
K151143 04/29/2015 EndoLIF On-Cage JOIMAX GMBH Eulodie Tila
K151007 04/15/2015 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) JVC KENWOOD CORPORATION Tsukasa Tashiro
K151134 04/29/2015 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) JVC KENWOOD CORPORATION Tsukasa Tashiro
K150983 04/14/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K150865 04/01/2015 Metacross RX PTA Balloon Dilitation Catheter Kaneka Corporation Toshihiko Motomine
K151060 04/20/2015 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Shigeyuki Kojima
K151140 04/29/2015 LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd Yerim An
K150878 04/01/2015 ILUMIEN OPTIS LIGHTLAB IMAGING,INC. ERDIE DE PERALTA
K150903 04/03/2015 EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. Viva Gu
K150928 04/06/2015 Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides MATERIALISE N.V. Laurel Berzanskis
K151023 04/16/2015 COMPACT PIEZO LED MECTRON SPA FRANCO ZUNINO
K150986 04/14/2015 Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants MEDDEV CORPORATION PATRICK GREY
K151117 04/27/2015 Laparoscope Lens Shield Device Medeon Biodesign, Inc Greta Chang
K150887 04/02/2015 Para-Fix C&S Medium MEDICAL CHEMICAL CORPORATION KRIS J KONTIS
K151001 04/15/2015 MUSE System MEDIGUS LTD. YANIV SAGIE
K151000 04/15/2015 O-Arm O2 Imaging System MEDTRONIC INC. RISHI SINHA
K151128 04/28/2015 CAPSTONE Spinal System, CLYDESDALE Spinal System MEDTRONIC SOFAMOR DANEK USA, INC LEE GRANT
K151067 04/21/2015 Ventilation (Tympanostomy) Tubes Medtronic Xomed, Inc. Michelle Hughes
K151110 04/27/2015 Intersept Filtered Cardiotomy Reservoir Medtronic, Inc Chelsea L Pioske
K151055 04/20/2015 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE MENTOR WORLDWIDE LLC Sarah McManus
K151046 04/20/2015 illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 MERIDIAN BIOSCIENCE, INC. STEFANIE JOHNS
K150958 04/09/2015 LifePearl Microshperes MicroVention, Inc. Naomi Gong
K150912 04/03/2015 Houva-NET Control System National Biological Corporation Lynn Keller
K150993 04/15/2015 NICO TRIOwand NICO CORPORATION JAY DITTMAN
K151095 04/23/2015 Circumplast Circumcision Device Novadien Healthcare Milad Melhem
K150874 04/01/2015 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) NOVO NORDISK INC. Poonam Tuliani
K150994 04/15/2015 NuVasive CoRoent Thoracolumbar Implants NUVASIVE, INCORPORATED CYNTHIA ADAMS
K151011 04/15/2015 VISERA 4K UHD SYSTEM Olympus Medical Systems Corp. Toshiyuki Nakajima
K151147 04/30/2015 STARband, STARlight ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K151021 04/16/2015 OsteoMed Cannulated Screw System OSTEOMED CORP. Blesson Abraham
K150946 04/08/2015 FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm OSTIAL CORPORATION Jake Wolenberg
K150880 04/01/2015 Tablo Console with Wireless Capability Outset Medical Nancy Gallo
K151150 04/30/2015 Elements PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K151033 04/17/2015 Philips Self-Adhesive Electrodes PHILIPS CONSUMER LIFESTYLE MARTA WALKER
K151035 04/17/2015 PulseRelief PHILIPS CONSUMER LIFESTYLE Marta Walker
K150975 04/13/2015 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Michael Asmalsky
K150872 04/01/2015 BruxZir Anterior Milling Blanks PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K151079 04/22/2015 Q2 Intravenous Adminstration Sets and Extension Sets QUEST MEDICAL, INC. AMY CLENDENING-WHEELER
K150868 04/01/2015 Solana GAS Assay, Solana instrument QUIDEL CORPORATION RONALD H LOLLAR
K150910 04/03/2015 ACCU-CHEK Connect Diabetes Management App ROCHE DIABETES CARE INC. CHUNHONG TAO
K150955 04/09/2015 Elecsys Progesterone III Cal Check 5 ROCHE DIAGNOSTICS ADAM CLARK
K151082 04/22/2015 MicroCross Catheter ROXWOOD MEDICAL, INC. GRACE LI
K150894 04/02/2015 VIA 21 Microcatheter SEQUENT MEDICAL, INC Bethany Barrett
K150995 04/15/2015 Electronic Pulse Stimulator SHENZHEN JINGKEHUI ELECTRONIC CO., LTD PU JIANG
K150875 04/01/2015 iFuse Implant System SI-BONE, Inc. Roxanne Dubois
K150909 04/03/2015 INTEGO Family and Accesories Sirona Dental Systems GMBH Thomas Diesch
K151045 04/20/2015 TENEO Dental Treatment Unit and Accessories SIRONA DENTAL SYSTEMS GMBH THOMAS DIESCH
K150939 04/07/2015 Ensizor Endoscopic Scissors SLATER ENDOSCOPY, LLC JOHN STARKEY
K151118 04/27/2015 Smith and Nephew Legion Hinge Knee System SMITH & NEPHEW ALLISON CHAN
K151105 04/24/2015 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteorap Smith & Nephew, Inc. Katherine Marcaccio
K150981 04/14/2015 SMV Scientific Bone Screws SMV Scientific Nephi Zufelt
K150941 04/08/2015 Somnowell Mandibular Advancement Appliance (MAA) Somnowell Ltd. Simon Ash
K151053 04/20/2015 PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner SOPRO - ACTEON GROUP PHILIPPE BOYER
K150895 04/02/2015 SPEC Model M16 Source Production and Equipment Co.,Inc. Kelly Richardt
K151020 04/16/2015 Rampart-T Interbody Fusion System Spineology, Inc. Tim Crabtree
K151101 04/24/2015 Lotus Series 4 Ultrasonic Surgical System & Accessories SRA DEVELOPMENTS, LTD. Alan Chivers
K150968 04/13/2015 TRU Dental Implant System Sterngold Dental, LLC Maria Rao
K150899 04/03/2015 Straumann CARES Titanium Alloy (TAN) Abutment STRAUMANN USA, LLC Christopher Klaczyk
K150938 04/07/2015 Straumann« Dental Implant System ? Roxolid« SLA Implants STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K151076 04/22/2015 MicroTaper Needle Introducer Set Summit Access, LLC Fred Piazza
K150959 04/10/2015 Sutter Bipolar Forceps-Calvian SUTTER MEDIZINTECHNIK GMBH BERT SUTTER
K151100 04/24/2015 U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System TAIDOC TECHNOLOGY CORPORATION C.W. CHEN
K150824 04/01/2015 TD-Wand TDM SURGITECH, INC MICHAEL WEBER
K150973 04/13/2015 NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs TERANG NUSA SND BHD ROBERT HILL
K150919 04/06/2015 ArgenZ Esthetic Plus THE ARGEN CORPORATION CRAIG JOLICOEUR
K150871 04/01/2015 ForeFoot STP System TORNIER, INC. BRIAN HOCKETT
K150897 04/02/2015 Tosama 100% Cotton Menstrual Tampon TOSAMA D.O.O. Marjetka Kralj Kuncic
K151091 04/23/2015 Vitrea Software Toshiba Package, VSTP-001A Toshiba Medical Systems Corporation Paul Biggins
K150967 04/13/2015 XIDF-AWS801, Angio Workstation, V6.10 Toshiba Medical Systems Corporation Paul Biggins
K151087 04/23/2015 CS 8100SC, CS8100SC Access TROPHY MARIE-PIERRE LABAT-CAMY
K151151 04/30/2015 U & U Intravascular Administration Set U & U Medical Technology Co., Ltd Xuebo Wang
K151094 04/23/2015 Mosaic Universal Composite ULTRADENT PRODUCTS, INC. KAREN KAKUNES
K151115 04/27/2015 MR Core Software Vital Images, Inc Parthiv Shah
K151013 04/15/2015 Vitaphone Tele ECG Loop Recorder Vitasystems GmbH Michael Rothhaar
K151145 04/29/2015 2.4mm X 127 cm Phoenix Atherectomy Deflecting System Volcano AtheroMed, Inc. JEAN CHANG
K151008 04/15/2015 LINK« MEGASYSTEM-C« Waldemar Link GmbH & Co. KG Helmut D Link
K151142 04/29/2015 IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID WIELAND DENTAL + TECHNIK GMBH & CO. KG BETINA KISTNER
K151031 04/17/2015 Virage OCT Spinal Fixation System ZIMMER SPINE, INC DONNA M. SEMLAK
K150896 04/02/2015 Vitality Spinal Fixation System ZIMMER SPINE, INC. DONNA M. SEMLAK
K150889 04/02/2015 Suture Wires and Wire Loops ZIMMER, INC. PATRICK MCCULLAGH


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