| 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 |
