FDA 510(k) Applications Received During December, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K183476 12/17/2018 3M Filtek Universal Restorative 3M ESPE Dental Products Lam Duong
K183346 12/03/2018 FLOW 90 Wand Arthrocare Corporation Shruthi Bhat
K183615 12/26/2018 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle Avenu Medical, Inc. Dave Campbell
K183553 12/20/2018 Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc Michael McBurney
K183636 12/26/2018 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller Boston Scientific Corporation Carter Navarro
K183452 12/13/2018 Vbeam Prima Laser System Candela Corp. Sharon Timberlake
K183474 12/17/2018 Carestream DRX-1 System with DRX Core Detectors Carestream Health, Inc. Victoria Wheeler
K183467 12/14/2018 Roadrunner Extra Support Wire Guide Cook Incorporated Daniel J. Corbin
K183369 12/04/2018 COR12 ECG Corscience GmbH & Co. Karlheinz Trost
K183685 12/28/2018 O-Scan Esaote S.p.A Massimo Polignano
K183362 12/04/2018 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K183456 12/13/2018 Aloka Arietta 850 Hitachi Healthcare Americas Doug Thistlethwaite
K183406 12/10/2018 CereLink ICP Monitor, CereLink ICP Extension Cable Integra LifeSciences Corp. Megan Palumbo
K183581 12/21/2018 Codman Disposable Perforators Integra LifeSciences Corp. Jocelyn Raposo
K183713 12/10/2018 Wireless Digital Flat Detector iRay Technology Taicang Ltd. Meng Li
K183422 12/10/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K183348 12/03/2018 Reusable Silicone Cover CPRmeter 2 Laerdal Medical AS Mari Kaada
K183392 12/07/2018 PicoLO Nd:YAG Picosecond Laser System Laseroptek Co., Ltd. Hong Chu
K183671 12/27/2018 LG PRA.L DERMA LED MASK LG Electronics, Inc. Jooyong Kim
K183616 12/26/2018 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K183631 12/26/2018 medi pneumatic compression system (pcs) û brio (Model 651) Medi USA, LP Glenn Anderson
K183510 12/18/2018 T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton
K183497 12/17/2018 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183352 12/03/2018 Optimus Neuro System Osteonic Co., Ltd Seyoung Choi
K183541 12/20/2018 ProRad 2FC and ProRad 3NC Stationary Radiographic Systems Prognosys Medical Systems Private Limited V. Krishna Prasad
K183468 12/14/2018 Revive Reusable Bladder Support Rinovum Subsidiary 2, LLC Shaylee Masilunas
K183542 12/20/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K183643 12/26/2018 Clear Image Aligners Specialty Appliance Works, Inc. Carolyn Thomas
K183538 12/19/2018 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K183470 12/14/2018 Precision Ideal Eyes Arthroscopes Stryker Jessie Duong
K183696 12/31/2018 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc. Moyees Kamara
K183383 12/06/2018 ANAXÖ OCT Spinal System U & I Corporation Young Eun Lee
K183357 12/04/2018 XableCath Crossing Catheter XableCath, Inc. Rick Gaykowski
K183514 12/18/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Katherine Prendergast


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