Medical Device Manufacturer · US , Great Neck , NY

Tecnimed S.R.L. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 2004

5

Total

4

Cleared

1

Denied

FDA 510(k) Regulatory Record - Tecnimed S.R.L. General Hospital ✕

4 devices

1-4 of 4

Cleared Apr 19, 2017

VisioFocus Mini, VisioFocus Smart

General Hospital · 405d

Cleared Mar 13, 2013

General Hospital · 217d

Cleared Aug 31, 2007

MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

General Hospital · 30d

Cleared Jun 03, 2004

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

General Hospital · 182d