Medical Device Manufacturer · SE , Goteborg

Ascom (Sweden) AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011

Recent clearances: Unite Connect for Clinical Systems, ASCOM MOBILE MONITORING GATEWAY (MMG)

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ascom (Sweden) AB Cardiovascular ✕

2 devices

1-2 of 2

Cleared Apr 03, 2018

Unite Connect for Clinical Systems

Cardiovascular · 29d

Cleared Jul 05, 2011

ASCOM MOBILE MONITORING GATEWAY (MMG)

Cardiovascular · 64d

Data Source

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

Last updated: Jun 09, 2026