American Edwards Laboratories - FDA 510(k) Cleared Devices
89
Total
88
Cleared
0
Denied
89 devices
Cleared
Jun 12, 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
Cardiovascular
24d
Cleared
Jun 09, 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
Cardiovascular
21d
Cleared
May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
Cardiovascular
42d
Cleared
Mar 27, 1981
GANZ CORONARY REPERFUSION CATHETER
Cardiovascular
88d
Cleared
Mar 27, 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
Cardiovascular
45d
Cleared
Feb 04, 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
Cardiovascular
16d
Cleared
Feb 04, 1981
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
Cardiovascular
13d
Cleared
Jan 16, 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
Cardiovascular
45d
Cleared
Jan 13, 1981
FOGARTY BALLON ANGIOPLASTY CATHETERS
Cardiovascular
42d
Cleared
Jan 13, 1981
ADVANCEMED CCU DOCUMENTOR
Cardiovascular
25d
Cleared
Jan 13, 1981
ADVANCMED ELIMINATOR
Cardiovascular
25d
Cleared
Jan 13, 1981
ADVANCEMED HOLTER RECORDERS
Cardiovascular
25d
Cleared
Jan 13, 1981
ADVANCEMED EXAMINER
Cardiovascular
25d
Cleared
Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
Cardiovascular
30d
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