FDA 510(k) Applications Received During May, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181197 05/07/2018 PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Rose Guang
K181342 05/21/2018 JGH1 Bone Graft Substitute AgNovos Healthcare USA, LLC Felipe Aguel
K181298 05/16/2018 Harmony XL Multi-Application Platform Alma Lasers Inc. Rekha Anand
K181281 05/15/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181339 05/21/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K181141 05/01/2018 OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery Maritza Ward
K181301 05/17/2018 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K181280 05/15/2018 Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K181306 05/17/2018 Actifuse Flow Baxter Healthcare Corporation Daniel Davis
K181225 05/08/2018 ALTAPORE Baxter Healthcare Corporation Caitlin Ziebell
K181333 05/21/2018 ADVIA Centaur Herpes-1 IgG Biokit, S.A. Joan Guixer
K181334 05/21/2018 ADVIA Centaur Herpes-2 IgG Biokit, S.A. Joan Guixe
K181368 05/23/2018 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ?g/mL) bioMerieux, Inc. Jolyn Tenllado
K181300 05/17/2018 Embosphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K181343 05/21/2018 HeartSee Cardiac P.E.T. Processing Software Bracco Diagnostics Inc. Patrice Marchildon
K181179 05/02/2018 BrainScope One BrainScope Company Inc. Michael E Singer
K181323 05/18/2018 Atlas Gold PTA Dilatation Catheter C. R. Bard, Inc. Aaron Conovaloff
K181150 05/01/2018 ProtekDuo Mini Veno-Venous Cannula Set CardiacAssist Inc Greg Johnson
K181217 05/07/2018 VesoFlow Lite DVT Compression Device Caremed Supply, Inc. Tsung-Hsuan Liu
K181348 05/21/2018 Cartiva SCI Disposable Instrumentation Set Cartiva, Inc. Tanya Eberle
K181287 05/16/2018 Catalyst CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K181289 05/16/2018 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System Cepheid Yi-Ping Lin
K181185 05/03/2018 Change Healthcare Enterprise Viewer Change Healthcare Canada Company Nadia Marchant
K181327 05/18/2018 InPen Dose Calculator Companion Medical, Inc. Jasper Benke
K181276 05/14/2018 CONOD Enteral Feeding Sets Conod Medical Co., Limited Cheng Run
K181206 05/07/2018 GentleCath Glide Intermittent Urinary Catheter ConvaTec Limited Elinor Jones
K181144 05/01/2018 Angled Tip Ureteral Catheter Cook Incorporated Chelsea Woods
K181351 05/22/2018 Double Flexible Tipped Wire Guides Cook Incorporated Jennifer Allman
K181389 05/25/2018 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Covidien Celso Duran
K181219 05/07/2018 OptiPillows EPAP Mask Cpapnea Medical Supply Sal T. Hakim
K181410 05/30/2018 MotoCLIP/HiMAX Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181261 05/11/2018 Curiteva Cervical Interbody Fusion System Curiteva, LLC Eric Linder
K181189 05/03/2018 ATLANTIS Conus Structure Dentsply Sirona Karl Nittinger
K181156 05/01/2018 Panther Fusion GBS Assay Diagenode Geraldine Poncin
K181318 05/18/2018 ONIS-PACS DigitalCore Co., Ltd Lemoigne Cedric
K181398 05/29/2018 DV-300 Aspirator Ding Hwa Co., Ltd. Eric Han
K181234 05/09/2018 Self-adhesive Electrode Dong Guan Ou Kang Electronics CO., LTD Nianjun Liu
K181346 05/21/2018 CystoSure Plus Catheter Emmy Medical, LLC. Ronald Adams
K181364 05/23/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K181151 05/01/2018 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System Ethicon Inc Debbie Fazen
K181268 05/14/2018 PROLENE (Polypropylene) 3D Patch Ethicon, Inc. Melina Escobar
K181207 05/07/2018 Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Everyway Medical Instruments CO., LDT. Paul Hung
K181290 05/16/2018 Fusion Bx 2.0 Focal Healthcare Inc. Karen Zhou
K181153 05/01/2018 ICEfx Cryoablation System Galil Medical Inc. Rachel Owens
K181295 05/16/2018 Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine Benjamin V. Keller
K181376 05/24/2018 ARIETTA 65 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K181363 05/23/2018 EcoVue Sterile and Non-Sterile Ultrasound Gels HR Pharmaceuticals, Inc. Colby Wiesman
K181228 05/08/2018 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K181359 05/22/2018 InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K181325 05/18/2018 Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K181201 05/07/2018 Synermed ISE Reagents Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K181395 05/29/2018 Universal Cannula Seal (5-12 mm) Intuitive Surgical, Inc. Cheryl Wu
K181316 05/18/2018 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K181188 05/03/2018 EVEREST Spinal System K2M Inc. Nancy Giezen
K181242 05/10/2018 Braun BNT400 No Touch + Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K181146 05/01/2018 ASK System L and K Biomed Corporation Limited Semi Jang
K181230 05/09/2018 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K181232 05/09/2018 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co. Ltd. Amy Tien
K181167 05/02/2018 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd Charles Shen
K181425 05/31/2018 APTUS« Proximal Humerus System Medartis AG Andrea Schweizer
K181175 05/02/2018 12F Tri-Flow Triple Lumen Catheter Medical Components Inc. (Dba Medcomp) Courtney Nix
K181182 05/03/2018 DYNACORD Suture Medos International SARL Tatyana Korsunsky
K181257 05/11/2018 PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy Heather Valley
K181399 05/29/2018 FIREFLY« Pedicle Screw Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K181178 05/02/2018 S-mini active Fixture Neobiotech Co., Ltd. Young-Ku Heo
K181345 05/21/2018 Image Filing Software NAVIS-EX Nidek Co., Ltd Yoneji Mizuno
K181202 05/07/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K181386 05/25/2018 NuVasive Brigade Lateral System NuVasive, Incorporated Jessica Silverman
K181193 05/04/2018 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K181375 05/24/2018 Apex Femoral Nailing System OrthoXel Aisling O'Sullivan
K181347 05/21/2018 Aries« Lumbar Interbodies Osseus Fusion Systems, LLC Robert Pace
K181329 05/18/2018 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB Carina Magnusson
K181177 05/02/2018 Interventional Workspot Philips Medical Systems Nederland BV Chandrika Srinivasan
K181264 05/14/2018 QLAB Advanced Quantification Software Philips Ultrasound Inc. Penny Greco
K181253 05/11/2018 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K181313 05/17/2018 BenQ Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K181401 05/29/2018 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K181414 05/30/2018 uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K181413 05/30/2018 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K181213 05/07/2018 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. Kira Gordon
K181407 05/30/2018 Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc. Patricia D. Jones
K181279 05/15/2018 Ysio Max Siemens Medical Solutions, Inc. Denise Adams
K181271 05/14/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K181203 05/07/2018 Juliet Ti Spineart Frank Pennesi
K181350 05/22/2018 ASTRA-OCT Spine System SpineCraft LLC Ami Akallal-Asaad
K181422 05/31/2018 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit SPR Therapeutics, Inc. Kathryn Stager
K181382 05/25/2018 GuardianTM Burr Hole Cover System St Jude Medical Rebecca Brunson
K181308 05/17/2018 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeffrey Stanifer
K181400 05/29/2018 H. PYLORI CHEKÖ TECHLAB, Inc. Donna T. Link
K181379 05/24/2018 H. PYLORI QUIK CHEK TECHLAB, Inc. Donna T. Link
K181358 05/22/2018 Televere Digital Dental Imaging System Televere Systems, Inc. Randell Quaal
K181367 05/23/2018 Tenex Health TX System Tenex Health, Inc. David Vancelette
K181237 05/10/2018 Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation Liang Lu
K181184 05/03/2018 OIC Intramedullary Nail System The Orthopaedic Implant Company Douglas Fulton
K181408 05/30/2018 JO Classic Hybrid Personal Lubricant United Consortium Stephanie Morris
K181145 05/01/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K181404 05/29/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc. Peter J. Coronado
K181262 05/11/2018 SpineJack Expansion Kit Vexim SA Vincent Gardes
K181218 05/07/2018 AlignRT Plus Vision RT Ltd Chris Hannan
K181312 05/17/2018 GrandioSO x-tra VOCO GmbH M. Th. Plaumann
K181272 05/14/2018 Picocare Family WON TECH Co., Ltd. Hyunsik Yoon
K181244 05/10/2018 Zavation Cervical Plate System Zavation Medical Products LLC Matt Jones
K181246 05/10/2018 Zavation IBF System Zavation Medical Products LLC Matt Jones
K181149 05/01/2018 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations Greg Binversie


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