Medical Device Manufacturer · ES , Barcelona

Gem-Med S.L. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2009

Recent clearances: GEM HEART ONE/ONE+

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gem-Med S.L. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Sep 04, 2009

GEM HEART ONE/ONE+

Cardiovascular · 14d

Data Source

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

Last updated: Oct 03, 2026