FDA 510(k) Applications Received During June, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151687 06/23/2015 QuantorView 3DISC AMERICAS SIGRID SMITT-JEPPESEN
K151566 06/10/2015 Abbott ARCHITECT Total T4 Calibrators ABBOTT LABORATORIES Lisa Lukowski
K151595 06/12/2015 On Call Express Pro Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K151554 06/09/2015 Occlusion Perfusion Catheter ADVANCED CATHETER THERAPIES, INC. PAUL JOSEPH FITZPATRIC
K151696 06/23/2015 Caiman Seal and Cut Technology AESCULAP, INC. Denise Adams
K151464 06/01/2015 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit ALERE SCARBOROUGH, INC. ANGELA DRYSDALE
K151690 06/23/2015 Alere i Instrument, Alere i Influenza A & B, Alere i Strep A ALERE SCARBOROUGH, INC. Angela Drysdale
K151599 06/12/2015 iSy Implant System Altatec GmbH Colleen Boswell
K151460 06/01/2015 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD. LIU YI
K151513 06/04/2015 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow Internation, Inc. (subsidiary of Teleflex Inc.) Tracy Larish
K151732 06/26/2015 Arthrex Fracture Plates ARTHREX, INC. COURTNEY SMITH
K151660 06/19/2015 MultiFIX S Knotless Fixation System ArthroCare Corporation Laura Kasperowicz
K151459 06/01/2015 Integra Total Ankle Replacement System Ascension Orthopedics Frederic Testa
K151678 06/22/2015 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K151505 06/04/2015 Coronis Uniti Barco N.V. Franky Dubois
K151742 06/29/2015 Contour Next Control Solution BAYER HEALTHCARE JENNIFER L. GREGORY
K151698 06/24/2015 BD Angiocath IV Catheter, BD Insyte IV Catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. HENRY BOLAND
K151766 06/30/2015 BD Single Use, Hypodermic Syringe BECTON, DICKINSON AND COMPANY MURTAZA RANA
K151615 06/15/2015 TiTHON Staple with OsseoTi Technology BIOMET MANUFACTURING CORP. Patricia Sandborn Beres
K151483 06/02/2015 Biomet Spine Fusion System Biomet Spine LLC. Ted Kuhn
K151760 06/29/2015 Barricade Embolization Coil System BLOCKADE MEDICAL REBECCA K. PINE
K151516 06/05/2015 Capillus82 Capillus, LLC PATRICIA SCHNOOR
K151676 06/22/2015 Retracta Detachable Embolization Coil COOK INCORPORATED DAVID LEHR
K151649 06/18/2015 Valleylab FT10 Electrosurgical Platform COVIDIEN Sharon McDermott
K151548 06/09/2015 VersaOne Bladed Trocar, VersaOne Bladeless Trocar COVIDIEN Trang Huynh
K151659 06/19/2015 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien LLC Mary Mellows
K151568 06/10/2015 Arthrex OrthoVis Preoperative Plan Custom Orthopaedic Solutions, Inc. Peter O'Neill
K151501 06/04/2015 OrthoVis Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS,INC. Justin Baker
K151514 06/05/2015 Prestige DANVILLE MATERIALS LLC DONG HUA
K151509 06/04/2015 GSI TympStar Pro Middle Ear Analyzer Diagnostic Group, dba Grason-Stadler Ron Rolfsen
K151485 06/02/2015 GENESIS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K151575 06/11/2015 Dynarex Eye Cups DYNAREX CORPORATION JAMES HURLMAN
K151561 06/10/2015 Leksell Gamma Knife Icon ELEKTA INSTRUMENT AB MATILDA FORSBERG
K151666 06/19/2015 Leksell GammaPlan ELEKTA INSTRUMENT AB MATILDA FORSBERG
K151552 06/09/2015 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II ELITechGroup Valerie Gourdon
K151668 06/19/2015 S-scan ESAOTE S.P.A. DONATELLA RAGGHIANTI
K151473 06/01/2015 NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module FOCUS MEDICAL, LLC. John B Lee
K151587 06/11/2015 Digital Automatic Wrist Blood Pressure Monitor MD3200 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K151583 06/11/2015 Digital Automatic Wrist Blood Pressure Monitor MD3900 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K151478 06/02/2015 Wondfo CR3 Keyless Split Sample Cup GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K151463 06/01/2015 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components HANSEN MEDICAL, INC. Elisa Aldridge
K151730 06/26/2015 Magellan Robotic System HANSEN MEDICAL, INC. TODD MILHOLLAND
K151684 06/22/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K151642 06/18/2015 Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K151740 06/26/2015 JAZZ System Implanet, S.A. Regis Le Couedic
K151576 06/11/2015 Neon EEG Incereb Ltd PAUL PHILLIPS
K151534 06/08/2015 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K151616 06/15/2015 AT235 INTERACOUSTICS A/S ERIK NIELSEN
K151564 06/10/2015 Telio CAD Abutment Solutions IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K151591 06/12/2015 Angel pedicle screw spinal system JIANGSU ANGEL MEDICAL INSTRUMENT CO., LTD SHENG XIANG MA
K151727 06/26/2015 Everest Spinal System K2M, INC NANCY GIEZEN
K151465 06/01/2015 AeroDR SYSTEM 2 KONICA MINOLTA, INC. SHIGEYUKI KOJIMA
K151677 06/22/2015 LnK Cervical Interbody Fusion Cage System L&K BIOMED Co.,Ltd. Yerim An
K151702 06/24/2015 Reusable Full Silicone Cover LAERDAL MEDICAL AS MARI KAADA
K151522 06/05/2015 DEFENDO Bronchoscopy Suction Valve MEDIVATORS, INC. Jeff Kasoff
K151628 06/17/2015 Medline ENFit Connectors MEDLINE INDUSTRIES, INC. STEPHANIE BLAIR
K151532 06/08/2015 KYPHON ELEMENT Inflatable Bone Tamp MEDTRONIC, INC. PAMELA EDWARDS
K151523 06/05/2015 Uncoated Tubing and Connector Components MEDTRONIC, INC. JACQUELINE A. HAUGE
K151768 06/30/2015 Menicon Saline Rinse Solution MENICON CO.,LTD. TOHRU KAWAGUCHI
K151497 06/04/2015 EN Snare Endovascular Snare System MERIT MEDICAL SYSTEMS INC MARK MULLANEY
K151543 06/08/2015 Graft Delivery Device with Integrated Stylet Micromedics Inc. (d/b/a Nordson Medical) Amy L Peterson
K151536 06/08/2015 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm MRI INTERVENTIONS, INC. E F WADDELL
K151557 06/10/2015 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine NANTONG EGENS BIOTECH CO., LTD. BEN CHEN
K151654 06/18/2015 PROW FUSION NLT SPINE LTD Eti Zinger
K151472 06/01/2015 NuVasive CoRoent Lumbar System NuVasive, Incorporated Martin A Yahiro
K151538 06/08/2015 NuVasive PEEK Corpectomy Railed System NuVasive, Incorporated Olga Lewis
K151651 06/18/2015 NuVasive X-CORE Mini Cervical Expandable VBR System NUVASIVE, INCORPORATED Olga Lewis
K151488 06/02/2015 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Orthofix, Inc. Jacki Geren
K151518 06/05/2015 BRUSH&BOND PLUS Parkell, Inc. David Mott
K151572 06/11/2015 Penumbra Smart Coil PENUMBRA, INC. CHARLES DENAULT
K151623 06/16/2015 Penumbra System 110 Aspiration Tubing Penumbra, Inc. Michaela Mahl
K151604 06/15/2015 23ga Chandelier Illuminator, 25ga Chandelier Illuminator PEREGRINE SURGICAL LTD. RYAN O'LEARY
K151598 06/12/2015 VesselNavigator Rel. 1.0 PHILIPS MEDICAL SYSTEMS NEDERLAND BV LISELOTTE KORNMANN
K151681 06/22/2015 IntelliVue Patient Monitor PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH JOHANNES SCHMID
K151761 06/29/2015 SureSigns VS3, SureSigns VS4 PHILLIPS MEDICAL SYSTEMS Greg Li
K151521 06/05/2015 Phoenix Thera-Lase System PHOENIX THERA-LASE SYSTEMS, LLC GARY BELLINGER
K151630 06/17/2015 G.o.c.c.l.e.s. PIERREL PHARMA S.R.L. FABIO VELOTTI
K151530 06/08/2015 CardioChek Plus Test System POLYMER TECHNOLOGY SYSTEMS, INC. Megan Burns
K151728 06/26/2015 CoStorSol plus G PRESERVATION SOLUTIONS, INC. GARY SWANSON
K151709 06/24/2015 Hi-Light Diagnostic Ultrasound Systems Qingdao Hisense Medical Equipment Co., Ltd. Wang Wei
K151753 06/29/2015 16 ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC Kathleen Aras
K151707 06/24/2015 EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i RAYENCE CO., LTD KEVIN KIM
K151756 06/29/2015 STERISPINE LC CAGE SAFE ORTHOPAEDICS Pierre Dumouchel
K151685 06/22/2015 GUA60A, GU60A-65 SAMSUNG ELECTRONICS CO., LTD. Chulsin Kim
K151663 06/19/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KYEONG-MI PAK
K151653 06/18/2015 8ch Foot Ankle Coil SHENZHEN RFTECH CO., LTD. KE XI
K151462 06/01/2015 SI-TECHNOLOGY« SI-DESIS« SCREWS SI-TECHNOLOGY, LLC CHRIS DONNER
K151486 06/02/2015 Biograph mCT and mCT Flow PET/CT Scanners Siemens Medical Solutions USA, Inc. ALAINE MEDIO
K151579 06/11/2015 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151645 06/18/2015 MAMMOMAT Fusion Siemens Medical Solutions USA, Inc. Darren Dorman
K151560 06/10/2015 QuickPlan Siris Medical Colin M Carpenter
K151637 06/17/2015 UPT Series Medical RO Water System Specialty Water Technologies Alex Clark
K151705 06/24/2015 Lotus Posterior Cervical/Thoracic Spinal System SPINAL ELEMENTS, INC. CECILIA SILVA
K151741 06/26/2015 HA Minuteman G3 MIS Fusion Plate SPINAL SIMPLICITY LLC JULIE MCKEE
K151581 06/11/2015 Leva Spacer System SPINE WAVE, INC. GAIL YAEKER-DAUNIS
K151695 06/23/2015 Romeo posterior osteosynthesis system SPINEART FRANCK PENNESI
K151622 06/16/2015 St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electroph St. Jude Medical Maria Obreztchikova
K151755 06/29/2015 OASYS(r) System Stryker Corporation Garry T Hayeck
K151592 06/12/2015 Gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. Xue Fang Zhou
K151526 06/08/2015 Zone, ZoneFree, Zone A1 SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K151655 06/18/2015 CO2RE System SYNERON MEDICAL LTD. Ruthie Amir
K151471 06/01/2015 Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation Phebe Varghese
K151647 06/18/2015 Uberlube UBERLUBE LLC JACK MAGNUSEN
K151533 06/08/2015 Respiratory Gating for Scanners VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151657 06/19/2015 Shielded Applicator Set, Cervical Stop VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151733 06/26/2015 Xenco Medical Pedicle Screw System Xenco Medical, LLC GUSTAVO PRADO
K151601 06/12/2015 SECURE-LOOP XIROS LTD STEPHEN SEED
K151586 06/11/2015 Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN


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