Bioptimal International Pte. , Ltd. is one of 29 FDA 510(k) medical device manufacturers from Singapore in the dataset, ranked by real submission volume.
Bioptimal International Pte. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N, Bioptimal Bipolar Pacing Catheter
2
Total
2
Cleared
0
Denied
Bioptimal International Pte. , Ltd. has 2 FDA 510(k) cleared medical devices. Based in Singapore, SG.
Latest FDA clearance: May 2026. Active since 2025. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Bioptimal International Pte. , Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bioptimal International Pte. , Ltd.
2 devices