University of Michigan is one of 20339 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
University of Michigan - FDA 510(k) Cleared Devices
Recent clearances: MR EXTENSION SET (001), CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
2
Total
2
Cleared
0
Denied
University of Michigan, is an academic medical institution with a manufacturing facility in Ann Arbor, US. The organization has pursued FDA 510(k) clearance for specialized medical devices.
The institution received 2 FDA 510(k) clearances from 2 total submissions between 1990 and 1997. Cleared devices span general hospital and radiology applications, including extension sets and imaging-compatible applicator systems. This regulatory activity represents a historical record; no clearances have been granted since 1997.
Review the complete clearance history, device names, product codes, and approval dates in the full regulatory database record.
FDA 510(k) Regulatory Record - University of Michigan
2 devices