Universal Medical, Inc. is one of 20576 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Universal Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HEARTRAK SMART ECAT, HEARTRAK AF, HEARTRAK SMART AT/HEARTRAK SMART2
8
Total
8
Cleared
0
Denied
Universal Medical, Inc. has 8 FDA 510(k) cleared medical devices. Based in Philadelphia, US.
Historical record: 8 cleared submissions from 1995 to 2008. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Universal Medical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Universal Medical, Inc.
8 devices
Cleared
Dec 15, 2008
HEARTRAK SMART ECAT
Cardiovascular
17d
Cleared
May 14, 2008
HEARTRAK AF
Cardiovascular
387d
Cleared
Feb 05, 2004
HEARTRAK SMART AT/HEARTRAK SMART2
Cardiovascular
98d
Cleared
May 11, 1998
CARDIOSTATION
Cardiovascular
82d
Cleared
Aug 06, 1996
HEARTRAK XL
Cardiovascular
186d
Cleared
Apr 22, 1996
PACETRAK PLUS
Cardiovascular
208d
Cleared
May 03, 1995
PACETRAK
Cardiovascular
308d
Cleared
May 03, 1995
HEARTRAK
Cardiovascular
308d