Medical Device Manufacturer · KR , Gyeonggi-Do

Uzinmedicare Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Uzinmedicare Co., Ltd. Obstetrics & Gynecology ✕
4 devices
1-4 of 4
Cleared Apr 06, 2026
SPECTRA Wearable 2
K250208 · HGX
Obstetrics & Gynecology · 437d
Cleared Feb 06, 2026
Spectra S1 Pro
K251423 · HGX
Obstetrics & Gynecology · 274d
Cleared Nov 25, 2025
Spectra Platinum
K251932 · HGX
Obstetrics & Gynecology · 154d
Cleared Dec 12, 2022
Spectra Wearable
K220926 · HGX
Obstetrics & Gynecology · 256d
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