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Bd

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2026-02-20

SEC Filings: 3 filings on record. Latest: 10-Q (2026-08-06). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)FQH2026-02-20 View
510(k) K240257 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitDTK2024-02-29 View
510(k) K232434 BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitPSZ2023-12-05 View
510(k) K223016 BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ2023-01-27 View
510(k) K221504 BD Surgiphor™ Antimicrobial Irrigation SystemFQH2022-10-14 View
510(k) K180438 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ2018-03-20 View