Medical Device Manufacturer · US , New York , NY

Bioarchitects USA, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2015

Recent clearances: BioArchitects Patient Specific Cranial/Craniofacial Plate

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioarchitects USA, LLC Neurology ✕

1 devices

1-1 of 1

Cleared Nov 20, 2015

BioArchitects Patient Specific Cranial/Craniofacial Plate

Neurology · 150d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 22, 2026