Medical Device Manufacturer · US , Philadelphia , PA

Universal Medical, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1995

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Universal Medical, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Dec 15, 2008

HEARTRAK SMART ECAT

Cardiovascular · 17d

Cleared May 14, 2008

Cardiovascular · 387d

Cleared Feb 05, 2004

HEARTRAK SMART AT/HEARTRAK SMART2

Cardiovascular · 98d

Cleared May 11, 1998

Cardiovascular · 82d

Cleared Aug 06, 1996

Cardiovascular · 186d

Cleared Apr 22, 1996

Cardiovascular · 208d

Cleared May 03, 1995

Cardiovascular · 308d

Cleared May 03, 1995

Cardiovascular · 308d