FDA 510(k) Applications Received During May, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151369 05/21/2015 .decimal p.d .DECIMAL, LLC KEVIN ERHART
K151302 05/15/2015 Clinpro Varnish 3m Company Shari L. Myszka
K151317 05/18/2015 Armada 18 PTA Catheter ABBOTT VASCULAR Shu Chi Hsu
K151363 05/21/2015 Zephyr Vascular Compression Device ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K151322 05/18/2015 Amendia Interbody Fusion Devices AMENDIA, INC. BRUCE HOOPER
K151256 05/12/2015 Arthrex BioSync« Bone Wedge Arthex, Inc Laura Medlin
K151230 05/08/2015 Arthrex FiberTak Anchors Arthrex, Inc. Ivette Galmez
K151211 05/06/2015 AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup Assure Tech. Co., Ltd Eric Lin
K151437 05/29/2015 ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug ATRIUM MEDICAL CORPORATION TIMOTHY J. TALCOTT
K151301 05/15/2015 BD Veritor (TM) System for the Rapid Detection of Flu A + B Becton Dickinson and Company Gregory P Payne
K151291 05/15/2015 BD Veritor (TM) System for the Rapid Detection of Flu A+B BECTON DICKINSON AND COMPANY GREGORY P PAYNE
K151206 05/06/2015 Fingertip Pulse Oximeter BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K151280 05/14/2015 MultiScan G-Arm System BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. June Li
K151219 05/07/2015 Models 2200DR and 1600DR Digital Stationary Radiographic Systems BEIJING POLYCON MEDICAL ENGINEERING COMPANY XIANGCHEN LIU
K151173 05/01/2015 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation Lauren Jasper
K151224 05/07/2015 Lineum OCT Spine System BIOMET SPINE Spencer Kimber
K151187 05/04/2015 QuadraSphere Microspheres BIOSPHERE MEDICAL S.A. ALIX FONLLADOSA
K151409 05/26/2015 Selectra Catheters and Selectra Accessory Kit BIOTRONIK, INC. JON BRUMBAUGH
K151313 05/18/2015 ZelanteDVT Thrombectomy Set BOSTON SCIENTIFIC CORPORATION ANNE V. ROSSI
K151253 05/12/2015 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter BOSTON SCIENTIFIC LIMITED LISA MEE
K151325 05/18/2015 Bovie J-Plasma Handpiece BOVIE MEDICAL CORPORATION Brian Kunst
K151177 05/01/2015 XenMatrix AB Surgical Graft C.R. Bard Tony John
K151260 05/12/2015 ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD Cardiovascular System, Inc. Kim Wallner
K151379 05/22/2015 Conventus PRS System Conventus Orthopaedics, Inc Kent R Lind
K151306 05/18/2015 Solea CONVERGENT DENTAL, INC Mike Manor
K151204 05/05/2015 HEMO-Bandage CORELEADER BIOTECH CO., LTD. Ya-Wen Kuo
K151408 05/26/2015 LOSPA IS Spinal System CORENTEC CO., LTD GOON HEE LEE
K151163 05/01/2015 Signia Loading Unit, Tri-Staple 2.0 Cartridge Covidien LLC Frank Gianelli
K151356 05/20/2015 Spacemaker Pro Access and Dissector System Covidien LLC Rebecca Magnanimo
K151270 05/13/2015 CrossTIE Intraosseous Fixation System CrossRoads Extremity Systems LLC Vernon Hartdegen
K151254 05/12/2015 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump DATASCOPE CORP. Helder A Sousa
K151189 05/04/2015 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System Devon Medical Products ROCCO BRAVOCO
K151240 05/11/2015 extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Devon Medical Products JOHN SIEGEL
K151281 05/14/2015 AGE Automatic Wrist Blood Pressure Monitor DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD VICTOR WAN
K151298 05/15/2015 Gemini XXP-HP Dornier MedTech America John Hoffer
K151319 05/18/2015 Eko Electronic Stethoscope System Eko Devices, Inc. Connor Landgraf
K151340 05/19/2015 HARMONIC Focus Long Shears + Adaptive Tissue Technology ETHICON ENDO-SURGERY, LLC MARJORIE MEDINA
K151200 05/05/2015 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, INC. DONNA MARSHALL
K151346 05/20/2015 Frontier Medical Devices Posterior Cable Screw System FRONTIER MEDICAL DEVICES, INC. BETHANY BYMAN
K151372 05/21/2015 Low Dose CT Lung Cancer Screening Option for Qualified GE Systems GE Medical Systems, LLC John Jaeckle
K151343 05/19/2015 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) HARTALEGA NGC SDN BHD KUAN MUN LEONG
K151339 05/19/2015 SONON Ultrasound Imaging System (Model: SONON 300C) HEALCERION CO., LTD. JAEYEOB JUNG
K151348 05/20/2015 Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC JIANQIU FANG
K151164 05/01/2015 Assure Prism multi Blood Glucose Monitoring System i-Sens, Inc. JOON HO JUNG
K151232 05/08/2015 VIKINI Diode Laser System ILOODA CO., LTD Suhee Nam
K151203 05/05/2015 Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set IMMUNALYSIS CORPORATION JOSEPH GINETE
K151395 05/26/2015 Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Immunalysis Corporation Joseph Ginete
K151233 05/08/2015 Monaco IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K151246 05/11/2015 Aneroid Sphygmomanometer Jiaxing Zhongfa Medical Products Co., Ltd. Mao Xiaohua
K151400 05/26/2015 Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products JK HOLDING GmbH JUERGEN GERSTENMEIER
K151216 05/06/2015 Everest Spinal System K2M, Inc Nancy Giezen
K151394 05/26/2015 Keeler Slit Lamp KEELER LIMITED IRINA PROUTSKI
K151222 05/07/2015 Cautery Tip Cleaner KEY SURGICAL, INC. AMY YANTA
K151221 05/07/2015 Kubtec DIGIVIEW 395 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K151244 05/11/2015 Pre-Formed Guidewire Lake Region Medical Mathew Pexa
K151333 05/19/2015 LightStim for Pain LED Belt LED INTELLECTUAL PROPERTIES, LLC Steve Marchese
K151196 05/05/2015 Nautilus Spinal System LIFE SPINE, INC RANDY LEWIS
K151286 05/14/2015 OPTIS Integrated System Mobile Workstation LIGHTLAB IMAGING, INC. Padmini Suravaram
K151331 05/19/2015 The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch LUMENIS LTD ELISSA BURG
K151199 05/05/2015 SmartDrive Wheelchair Power Assist MAX MOBILITY, LLC Ben Hemkens
K151248 05/11/2015 PIEZOSURGERY WHITE MECTRON SPA MR. FRANCO ZUNINO
K151377 05/22/2015 ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare MEDICAL COMPRESSION SYSTEM (DBN) LTD. EYAL SANDACH
K151235 05/11/2015 Medline Foot Plates and Screws MEDLINE INDUSTRIES, INC. Jennifer Mason
K151236 05/11/2015 MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) MEDTRONIC MINIMED, INC. Liane R. Miller
K151172 05/01/2015 MASTERGRAFT Contain MEDTRONIC SOFAMOR DANEK USA, INC Gregory K Maschek
K151373 05/21/2015 Corvocet Coaxial Introducer Merit Medical Systems, Inc. Ileana Garcia
K151447 05/29/2015 Axium Detachable Coil System MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PATRICIA CASING
K151358 05/20/2015 AZUR CX Detachable 35 Coils Micro Vention, Inc. Cynthia Valenzuela
K151330 05/19/2015 Microlife Wrist Watch Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND GERHARD FRICK
K151238 05/11/2015 JUSHA-M23C LCD Monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD Ma Jing
K151160 05/01/2015 Arcus Staple System NEXTREMITY SOLUTIONS, INC. Ryan Schlotterback
K151305 05/18/2015 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) NONIN MEDICAL INC. LAURA J. LIND
K151341 05/19/2015 Turbo High-Flow Non-coring Needle NORFOLK MEDICAL NATAN PHEIL
K151407 05/26/2015 RECON system NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151277 05/14/2015 Airlock« osteosynthesis plate system NOVASTEP GILLES AUDIC
K151272 05/13/2015 Henschke Titanium Applicator Set NUCLETRON B.V. Lizette Van de Streek
K151214 05/06/2015 ALIF Interfixated System NuVasive, Incorporated Cynthia Adams
K151374 05/22/2015 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System NuVasive, Incorporated Olga Lewis
K151167 05/01/2015 NuVasive PEEK Corpectomy System NUVASIVE, INCORPORATED OLGA LEWIS
K151207 05/06/2015 Proton Immobilization Solution ORFIT INDUSTRIES NV EDDY MARIVOET
K151262 05/13/2015 Hyflex Heavy, Hyflex Mono, Hyflex Light Osstem Implant Co., Ltd Heekwon Son
K151195 05/04/2015 OsteoMed IMF Screw OSTEOMED Piedad Pena
K151418 05/28/2015 Monster Screw System PARAGON 28 FRANK S. BONO
K151184 05/04/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC REBECCA K PINE
K151314 05/18/2015 CinchLock Flex Knotless Suture Anchor Pivot Medical Kelly Kucharczyk
K151422 05/28/2015 Reform Pedicle Screw System Precision Spine, Inc. Michael C. Dawson
K151188 05/04/2015 BodyGuardian Remote Monitoring System PREVENTICE CHARLIE RECTOR
K151249 05/12/2015 PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON PUREWAY COMPLIANCE, INC JEFFERY MIGLICCO
K151438 05/29/2015 Dentrix Ascend Imaging REALCLOUD IMAGING INC. DOUGLAS A. GOLAY
K151446 05/29/2015 Recovr Rehabilitation System Recovr,Inc Austen Hayes
K151171 05/01/2015 TRAUS SUS10 SAESHIN PRECISION CO., LTD. SAE KWAN CHOI
K151419 05/28/2015 GF50A SAMSUNG ELECTRONICS CO., LTD. Chulsin Kim
K151180 05/04/2015 ScandiDos Delta4 Phantom+ SCANDIDOS AB THOMAS MATZEN
K151192 05/04/2015 syngo.via MI Workflows SIEMENS MEDICAL SOLUTIONS USA, INC VERONICA PADHARIA
K151353 05/20/2015 syngo.MR Neurology, syngo.MR Oncology SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151380 05/22/2015 syngo.via RT Image Suite SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K151326 05/18/2015 RENASYS? EZ PLUS Negative Pressure Wound Therapy Device Smith & Nephew, Inc. Laura Reynolds
K151215 05/06/2015 Mercury Spinal System Spinal Elements Inc. JULIE LAMOTHE
K151198 05/05/2015 A-CIFT SoloFuse SPINEFRONTIER, INC. MANTHAN J DAMANI
K151247 05/11/2015 NC Straumann Screw Retained Abutments STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K151157 05/01/2015 NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K151324 05/18/2015 Straumann Variobase for CEREC STRAUMANN USA, LLC Christopher Klaczyk
K151201 05/05/2015 Stryker ICONIX with Needles Stryker TAYLOR WHITE
K151387 05/26/2015 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade STRYKER JONATHAN SCHELL
K151243 05/11/2015 STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] Stryker Endoscopy GOLNAZ MOEINI
K151264 05/13/2015 Restoration Anatomic Shell STRYKER ORTHOPAEDICS Allison M Ling
K151178 05/04/2015 VariAx 2 Wrist Fusion System Stryker Trauma AG DR. HEIKE GUSTKE
K151166 05/01/2015 Instru-Safe Instrument Protection System Summit Medical Inc. Nicole Dove
K151332 05/19/2015 Nexus Universal, Nexus Universal Chroma SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K151241 05/11/2015 Synchro-Medical TIGER TRACK Screw System Synchro Medical Danilo Campani
K151276 05/13/2015 DePuy Synthes T-PAL Ti Spacer SYNTHES USA PRODUCTS LLC Eric Zhu
K151161 05/01/2015 VICTUS Femtosecond Laser Platform TECHNOLAS PERFECT VISION GMBH FRIEDRICH MORITZ
K151392 05/26/2015 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less TERANG NUSA SDN BHD ROBERT HILL
K151368 05/21/2015 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter TERUMO BCT Nicholas Wong
K151349 05/20/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation John Chesney
K151398 05/26/2015 K-Pack II Needle - 29G x 5/16 Thin Wall TERUMO EUROPE N.V. M. J. Aerts
K151245 05/11/2015 Rhythm View Workstation (non-streaming, steaming option) TOPERA, INC. Dennis Pozzo
K151293 05/15/2015 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis Tornier SAS Severine Bonneton
K151170 05/01/2015 Tosama 100% Organic Cotton Menstrual Tampon TOSAMA D.O.O. MARJETKA KRALJ KUNCIC
K151451 05/29/2015 Aplio 500/400/300 Diagnostic Ultrasound System V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K151440 05/29/2015 Klassic HD Hip System TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K151371 05/21/2015 Corporate Dental Imaging (CDI) Application U.S. ARMY DENTAL COMMAND (DENCOM) WILLIAM K. PORTER
K151213 05/06/2015 UCP Drug Test Mini Cups UCP BIOSCIENCES, INC NANCY CHEN
K151316 05/18/2015 U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation Karen Ho
K151345 05/19/2015 BioGuard Air/Water Valve, BioGuard Suction Valve UNITED STATES ENDOSCOPY GROUP, INC. CARROLL L. MARTIN
K151197 05/05/2015 Lariat snare UNITED STATES ENDOSCOPY GROUP, INC. SAGAR PIMPALWAR
K151208 05/06/2015 Powder Free Nitrile Examination Glove VRG KHAI HOAN JOINT STOCK COMPANY PHAM NGOC THANH
K151441 05/29/2015 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., INC. JOHN WAN
K151442 05/29/2015 TOTAL COMPRESSION PLATING (TCP) SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K151290 05/15/2015 Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff XUZHOU MAICUFF TECHNOLOGY CO.,LTD. LI ZHAOQIAN
K151309 05/18/2015 Wartie Advanced Wart Remover or other proprietary name YOUMEDICAL CORP BV FRANCESCA MAPPA
K151179 05/04/2015 ZELTIQ CoolSculpting System ZELTIQ AESTHETICS, INC. SHRUTI JAYAKUMAR
K151448 05/29/2015 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems ZIMMER, INC. KEITH PROCTOR
K151175 05/01/2015 ZONARE ZS3 Diagnostic Ultrasound System ZONARE MEDICAL SYSTEMS, INC. STEVE GEERDES


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