BunkerHill Health

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260167Bunkerhill Contrast AVCMarch 6, 2026
K260166Bunkerhill Contrast CACMarch 6, 2026
K250662Bunkerhill MACOctober 3, 2025
K250649Bunkerhill ECG-EFSeptember 19, 2025
K243779Bunkerhill Abdominal Aortic Quantification (AAQ)July 1, 2025
K242295BunkerHill BMDApril 8, 2025
K243229Bunkerhill AVCJanuary 27, 2025
K240369CAC (gated) AlgorithmSeptember 27, 2024