Medical Device Manufacturer · US , Philadelphia , PA

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

8 submissions · 8 cleared · Since 1995

Recent clearances: HEARTRAK SMART ECAT, HEARTRAK AF, HEARTRAK SMART AT/HEARTRAK SMART2

View 8 510(k) Devices ↓
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
K083535 · DXH
Cardiovascular · 17d
Cleared May 14, 2008
HEARTRAK AF
K071130 · DXH
Cardiovascular · 387d
Cleared Feb 05, 2004
HEARTRAK SMART AT/HEARTRAK SMART2
K033451 · DXH
Cardiovascular · 98d
Cleared May 11, 1998
CARDIOSTATION
K980624 · DXH
Cardiovascular · 82d
Cleared Aug 06, 1996
HEARTRAK XL
K960499 · DXH
Cardiovascular · 186d
Cleared Apr 22, 1996
PACETRAK PLUS
K954495 · DXH
Cardiovascular · 208d
Cleared May 03, 1995
PACETRAK
K943123 · DXH
Cardiovascular · 308d
Cleared May 03, 1995
HEARTRAK
K943124 · DXH
Cardiovascular · 308d
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