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BunkerHill Health

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

Total Devices8
Categories4
Latest FDA decision2026-03-06
TypeNumberDevice NameCodeDateActions
510(k) K260167 Bunkerhill Contrast AVCJAK2026-03-06 View
510(k) K260166 Bunkerhill Contrast CACJAK2026-03-06 View
510(k) K250662 Bunkerhill MACJAK2025-10-03 View
510(k) K250649 Bunkerhill ECG-EFQYE2025-09-19 View
510(k) K243779 Bunkerhill Abdominal Aortic Quantification (AAQ)QIH2025-07-01 View
510(k) K242295 BunkerHill BMDKGI2025-04-08 View
510(k) K243229 Bunkerhill AVCJAK2025-01-27 View
510(k) K240369 CAC (gated) AlgorithmJAK2024-09-27 View
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