Transonic Systems, Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Transonic Systems, Inc. Cardiovascular ✕
11 devices
Cleared
Jul 23, 2015
TRANSONIC TISSUE PERFUSION MONITOR
Cardiovascular
485d
Cleared
Jan 29, 2015
TRANSONIC ELSA SYSTEM
Cardiovascular
394d
Cleared
Sep 17, 2014
TRANSONIC HCM 103 SYSTEM
Cardiovascular
260d
Cleared
Sep 16, 2014
TRANSONIC HCM 102 SYSTEM
Cardiovascular
257d
Cleared
Sep 07, 2012
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Cardiovascular
255d
Cleared
Dec 21, 2011
AUREFLO MONITORING SYSTEM
Cardiovascular
99d
Cleared
Sep 08, 2008
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Cardiovascular
236d
Cleared
Dec 11, 2003
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER,...
Cardiovascular
49d
Cleared
Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
Cardiovascular
417d
Cleared
Oct 09, 1990
ADVANCE LASER FLOWMETER, ALF 21
Cardiovascular
60d
Cleared
Jun 21, 1988
TRANSONIC FLOWMETER
Cardiovascular
390d