Medical Device Manufacturer · IT , Scandicci (Fi)

Ascom Ums Srl Unipersonale - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2018

Recent clearances: Digistat Care, Digistat Smart Central

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ascom Ums Srl Unipersonale Cardiovascular ✕

2 devices

1-2 of 2

Cleared Sep 12, 2026

Cardiovascular · 145d

Cleared Nov 23, 2018

Digistat Smart Central

Cardiovascular · 280d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 05, 2026