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Bioptimal International Pte. , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Known Names

bioptimal international pte, bioptimal international pte.

Recent 510(k) Clearances

K-NumberDeviceDate
K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGMay 28, 2026
K242863Bioptimal Bipolar Pacing CatheterJune 15, 2025