Agnes Medical Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Agnes Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: AGNES Ultra, Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A), RFMagik Lite
7
Total
7
Cleared
0
Denied
Agnes Medical Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Seongnam-Si, KR.
Latest FDA clearance: Sep 2025. Active since 2019. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Agnes Medical Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by E & M and KMC, Inc..
FDA 510(k) Regulatory Record - Agnes Medical Co., Ltd.
7 devices
Cleared
Sep 03, 2025
AGNES Ultra
General & Plastic Surgery
222d
Cleared
Aug 19, 2025
Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S,...
General & Plastic Surgery
260d
Cleared
Apr 25, 2025
RFMagik Lite
General & Plastic Surgery
248d
Cleared
Feb 29, 2024
PlazMagik
General & Plastic Surgery
339d
Cleared
May 04, 2023
Agnes
General & Plastic Surgery
136d
Cleared
Jul 14, 2022
AGNES
General & Plastic Surgery
651d
Cleared
Oct 24, 2019
Agnes
General & Plastic Surgery
27d