Osstem Implant Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Healing Abutment System, Bone Screw, Estar-ZE
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osstem Implant Co., Ltd. Radiology ✕
6 devices
Cleared
Sep 06, 2024
T2 Plus
Radiology
282d
Cleared
Nov 28, 2023
N1
Radiology
145d
Cleared
Sep 21, 2021
T2
Radiology
60d
Cleared
Aug 30, 2019
T1-CS, T1-C
Radiology
256d
Cleared
Aug 26, 2014
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
Radiology
81d
Cleared
May 16, 2013
PORTABLE X-RAY SYSTEM
Radiology
302d