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FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories7
Latest FDA decision2026-05-14
TypeNumberDevice NameCodeDateActions
510(k) K260892 Suction Pump (SU-90)BTA2026-05-14 View
510(k) K250695 Single-use Ureteral Access SheathFED2025-07-08 View
510(k) K241444 Biliary Pancreaticobiliary Scope SystemFBN2025-01-21 View
510(k) K240374 Ureterorenoscope SystemFGB2024-05-10 View
510(k) K232435 Rhinolaryngoscope systemEOB2024-04-26 View
510(k) K231497 Choledochoscope SystemFBN2024-03-06 View
510(k) K231118 Cystoscope SystemFAJ2023-11-13 View
510(k) K222910 Bronchoscope SystemEOQ2023-04-11 View
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