Uzinmedicare Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Uzinmedicare Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Spectra Platinum Mini, SPECTRA Wearable 2, Spectra S1 Pro
5
Total
5
Cleared
0
Denied
Uzinmedicare Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Gyeonggi-Do, KR.
Latest FDA clearance: Jun 2026. Active since 2022. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Uzinmedicare Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by GMSC Co., Ltd. and Gms Consulting.
FDA 510(k) Regulatory Record - Uzinmedicare Co., Ltd.
5 devices
Cleared
Jun 04, 2026
Spectra Platinum Mini
Obstetrics & Gynecology
73d
Cleared
Apr 06, 2026
SPECTRA Wearable 2
Obstetrics & Gynecology
437d
Cleared
Feb 06, 2026
Spectra S1 Pro
Obstetrics & Gynecology
274d
Cleared
Nov 25, 2025
Spectra Platinum
Obstetrics & Gynecology
154d
Cleared
Dec 12, 2022
Spectra Wearable
Obstetrics & Gynecology
256d