FDA 510(k) Applications Received During June, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181471 06/04/2018 ACCUFUSE Cervical System Absolute Advantage Medical, LLC J.D. Webb
K181544 06/12/2018 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation Lisa Theama
K181585 06/15/2018 JGH1 Core Deccompression Procedure Kit AgNovos Healthcare USA, LLC Felipe Aguel
K181482 06/05/2018 myTAP2 Airway Management, Inc. Eric Jarrett
K181453 06/01/2018 ATEC ALIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181435 06/01/2018 ATEC Cervical Spacer System Alphatec Spine, Inc. Cynthia Adams
K181677 06/26/2018 Kodiak Spinal Fixation System Alphatec Spine, Inc. Cynthia Adams
K181513 06/08/2018 Arthrex PushLock Tenodesis Anchor Arthrex Inc. Ivette Galmez
K181474 06/04/2018 ArtiClip LAA Exclusion System AtriCure, Inc. Jonathan McElwee
K181465 06/04/2018 SpaceOAR System Augmenix, Inc. Marcus Garcia
K181627 06/20/2018 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated Melissa Thomas
K181493 06/06/2018 FilmArray Blood Culture Identification (BCID) Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181565 06/14/2018 Aquarius 8600 Digital Radiography Sensor Biokinemetrics Inc. Steven Kraus
K181554 06/13/2018 Stowe Pedicle Screw System Black Box Medical Todd Stanaford
K181439 06/01/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation Carter Navarro
K181466 06/04/2018 Cadwell Zenith System Cadwell Industries, Inc. Alison Hull
K181670 06/25/2018 Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181593 06/18/2018 Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation Paul Biggins
K181500 06/07/2018 BRILLIANT Crios Coltene/Whaledent AG Daniel Meier
K181431 06/01/2018 Laser Ureteral Catheter Cook Incorporated Carly Powell
K181712 06/28/2018 San Antonio Stopcock Cook Incorporated James O. Ebot Rnaw
K181713 06/28/2018 Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated Minjin Choi
K181592 06/18/2018 RAIN Sheath Transradial Cordis Corporation Ankita Phophalia
K181562 06/14/2018 Curiteva Anterior Cervical Plate System Curiteva, LLC Eric Linder
K181549 06/12/2018 Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC Eric Linder
K181582 06/15/2018 DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation Linda Hernandez
K181464 06/04/2018 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set DiaSorin Inc. John C. Walter
K181438 06/01/2018 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories Inc. Abhijit Datta
K181432 06/01/2018 ProVectra 3D Prime with VistaSoft Durr Dental SE Oliver Lange
K181579 06/15/2018 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K E&E Optics Inc. Bonnie Wan
K181574 06/15/2018 Uscan EchoNous, Inc. Trish Liau
K181547 06/12/2018 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K181609 06/19/2018 RadiForce GX560, GX560-AR EIZO Corporation Hiroaki Hashimoto
K181486 06/06/2018 DEKA Motus AY Elen Electronic Engineering Spa Paolo Peruzzi
K181720 06/29/2018 Epiphany Cardio Server Mobile Epiphany Healthcare, LLC Pat White
K181586 06/15/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K181700 06/27/2018 HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics Anna Klavins
K181676 06/25/2018 Mini Ridge Filter and auxiliary functions for PROBEAT-V Hitachi Ltd. Healthcare Hitachi Works Tomoyuki Seino
K181680 06/26/2018 ICONN Answer II Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K181694 06/27/2018 Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter Inari Medical Eben Gordon
K181473 06/04/2018 DENV Detect NS1 ELISA InBios International, Inc. Estela Raychaudhuri
K181584 06/15/2018 Redi-Spine Innovative Surgical Designs, Inc. Jon Rinehart
K181502 06/07/2018 Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. Rich Laguna
K181600 06/18/2018 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Jihyeon Seo
K181430 06/01/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K181708 06/28/2018 MTS Plazomicin 0.016-256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K181635 06/21/2018 GMK Sphere CR Tibial Inserts Medacta International SA Stefano Baj
K181543 06/12/2018 CureÖ OPEL-C Plate System Meditech Spine, LLC Bruce Dunaway
K181683 06/26/2018 BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181711 06/28/2018 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181499 06/07/2018 DRI Cocaine Metabolite Assay Microgenics Corporation Emily Chien
K181666 06/25/2018 Smart One MIR Medical International Research Gerda Van Houts
K181572 06/14/2018 Workflow Box Mirada Medical Ltd. Gwilym Owen
K181623 06/20/2018 Clarifi Imaging System Modulated Imaging, Inc. David Cuccia
K181437 06/01/2018 Pure Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K181483 06/05/2018 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K181522 06/11/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX of America, Inc. William Goeller
K181556 06/13/2018 EliA M2 Immunoassay Phadia AB Carina Magnusson
K181479 06/05/2018 Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
K181485 06/06/2018 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K181659 06/25/2018 Avologi ENEO Premier North America Inc. Yaniv Applicant
K181697 06/27/2018 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC Eric Yeh
K181452 06/01/2018 RCT800 Ray Co., Ltd. Changhwan Lee
K181706 06/28/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K181495 06/06/2018 Republic Spine Dark Star Spinal System Republic Spine, L.L.C. James Doulgeris
K181492 06/06/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K181626 06/20/2018 Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd. Chang Soeun
K181629 06/20/2018 GC85A Samsung Electronics Co., Ltd. Noh Jaesang
K181631 06/20/2018 GR40CW Samsung Electronics Co., Ltd. Noh Jaesang
K181436 06/01/2018 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test Sekisui Diagnostics, LLC Shelly Harris
K181509 06/08/2018 Endorate Valve Sets Smartdata Suzhou Co., Ltd Cindy Ye
K181533 06/11/2018 EVOS Wrist Fracture Plating System Smith & Nephew, Inc. Bryan Cowell
K181699 06/27/2018 Level 1 Convective Warmer Smiths Medical ASD, Inc. Donna M. Semlak
K181636 06/21/2018 Aurora Sodium Systems, LLC Brandon Bachler
K181440 06/01/2018 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K181429 06/01/2018 CELERITY 20 HP Biological Indicator STERIS Corporation Anthony Piotrkowski
K181686 06/26/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation Tony Piotrkowski
K181442 06/01/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K181480 06/05/2018 MMD Tip Strata Skin Sciences, Inc. Shmuel Gov
K181523 06/11/2018 Syneron CO2RE System Syneron-Candela Corp Sharon Timberlake
K181526 06/11/2018 XRpad2 4343 HWC-M Flat Panel Detector Varex Imaging Corporation Paul Sawicki
K181647 06/22/2018 Bandit guidewire Vascular Solutions, Inc. Becky Astrup
K181557 06/13/2018 INFINITY Total Ankle System Wright Medical Technology, Inc. Tara Conrad
K181484 06/05/2018 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Zirkonzahn Srl Sandra Leitner


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