ANI Co., Ltd. is one of 440 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
ANI Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Dental Barriers and Sleeves (AB0006)
1
Total
1
Cleared
0
Denied
ANI Co., Ltd. has 1 FDA 510(k) cleared medical devices. Based in Suwon-Si, Gyeonggi-Do, KR.
Latest FDA clearance: Sep 2026. Active since 2026. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by ANI Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by JNM KOREA CO.,Ltd as regulatory consultant.
FDA 510(k) Regulatory Record - ANI Co., Ltd.
1 devices