T&R BIOFAB CO., Ltd. is one of 440 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
T&R BIOFAB CO., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: TnR Cranial Implant, THERMOCLICK
2
Total
2
Cleared
0
Denied
T&R BIOFAB CO., Ltd. has 2 FDA 510(k) cleared medical devices. Based in Siheung-Si, KR.
Latest FDA clearance: Jul 2026. Active since 2023. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by T&R BIOFAB CO., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Lighten Bridge, LLC and K-Bio Solutions.
FDA 510(k) Regulatory Record - T&R BIOFAB CO., Ltd.
2 devices