Recensmedical, Inc. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Recensmedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TargetCool™ (RM-DT02W), TargetCool-e, TargetCool™
7
Total
6
Cleared
1
Denied
Recensmedical, Inc. has 6 FDA 510(k) cleared medical devices. Based in Hwaseong-Si, KR.
Latest FDA clearance: Oct 2025. Active since 2021. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Recensmedical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mtechgroup as regulatory consultant.
FDA 510(k) Regulatory Record - Recensmedical, Inc.
7 devices
Cleared
Oct 16, 2025
TargetCool™ (RM-DT02W)
General & Plastic Surgery
22d
Cleared
Oct 15, 2025
TargetCool-e
General & Plastic Surgery
15d
Not Cleared
Sep 30, 2024
OcuCool
Ophthalmic
592d
Cleared
Jun 22, 2023
TargetCool™
General & Plastic Surgery
111d
Cleared
Jul 22, 2022
TargetCool
General & Plastic Surgery
84d
Cleared
Mar 31, 2022
TargetCool
General & Plastic Surgery
23d
Cleared
May 13, 2021
CryoVIVE
General & Plastic Surgery
167d