Imedicom Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Imedicom Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: MEDINAUT Plus, EPINAUT
6
Total
6
Cleared
0
Denied
Imedicom Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Gunpo-Si, KR.
Historical record: 6 cleared submissions from 2016 to 2019. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Imedicom Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Imedicom Co., Ltd.
6 devices
Cleared
Apr 06, 2019
MEDINAUT Plus
Orthopedic
226d
Cleared
Aug 24, 2018
EPINAUT
Anesthesiology
282d
Cleared
Jul 29, 2016
MEDINAUT Kyphoplasty System
Orthopedic
259d
Cleared
Mar 18, 2016
SPINAUT-P
General & Plastic Surgery
347d
Cleared
Mar 16, 2016
SPINAUT-V, SPINAUT-S, SPINAUT-I
Orthopedic
308d
Cleared
Mar 01, 2016
SPINAUT-E, SPINAUT-I
Anesthesiology
342d