BunkerHill Health FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Bunkerhill Contrast AVC510(k)Mar 6, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2026
Bunkerhill Contrast CAC510(k)Mar 6, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2026
Bunkerhill MAC510(k)Oct 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 3, 2025
Bunkerhill ECG-EF510(k)Sep 19, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 19, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)510(k)Jul 1, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2025
BunkerHill BMD510(k)Apr 8, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 8, 2025
Bunkerhill AVC510(k)Jan 27, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 27, 2025
CAC (gated) Algorithm510(k)Sep 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 27, 2024