Infinitt Healthcare Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Infinitt Healthcare Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: INFINITT DPS, Xelis Dental 2.0, Infinitt RT PACS
4
Total
4
Cleared
0
Denied
Infinitt Healthcare Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Latest FDA clearance: Dec 2025. Active since 2017. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Infinitt Healthcare Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by O Tech, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Infinitt Healthcare Co., Ltd.
4 devices