BunkerHill Health is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
BunkerHill Health - FDA 510(k) Cleared Devices
Recent clearances: Bunkerhill Contrast CAC, Bunkerhill Contrast AVC, Bunkerhill MAC
8
Total
8
Cleared
0
Denied
BunkerHill Health has 8 FDA 510(k) cleared medical devices. Based in San Francisco, US.
Latest FDA clearance: Mar 2026. Active since 2024. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by BunkerHill Health Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan Lovells Llp.
FDA 510(k) Regulatory Record - BunkerHill Health
8 devices
Cleared
Mar 06, 2026
Bunkerhill Contrast CAC
Radiology
45d
Cleared
Mar 06, 2026
Bunkerhill Contrast AVC
Radiology
45d
Cleared
Oct 03, 2025
Bunkerhill MAC
Radiology
212d
Cleared
Sep 19, 2025
Bunkerhill ECG-EF
Cardiovascular
199d
Cleared
Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
Radiology
204d
Cleared
Apr 08, 2025
BunkerHill BMD
Radiology
249d
Cleared
Jan 27, 2025
Bunkerhill AVC
Radiology
111d
Cleared
Sep 27, 2024
CAC (gated) Algorithm
Radiology
233d