American Edwards Laboratories - FDA 510(k) Cleared Devices
89
Total
88
Cleared
0
Denied
53 devices
Cleared
Apr 18, 1983
FORGARTY CHIN PERIPHERAL INTRAOPERATIVE
Cardiovascular
41d
Cleared
Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
Cardiovascular
35d
Cleared
Jan 21, 1983
SIDEARM Y-ADAPTOR
Cardiovascular
81d
Cleared
Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
Cardiovascular
38d
Cleared
Oct 04, 1982
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
Cardiovascular
31d
Cleared
Aug 24, 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
Cardiovascular
18d
Cleared
Mar 15, 1982
TRANSLUMINAL BIPOLAR PACING PROBE
Cardiovascular
89d
Cleared
Feb 12, 1982
SWAN-GANZ VIP-CATHETER
Cardiovascular
16d
Cleared
Dec 29, 1981
EDSLAB CATHETER COVER
Cardiovascular
14d
Cleared
Nov 16, 1981
FOGARTY FLEXIBLE PROBE
Cardiovascular
27d
Cleared
Sep 25, 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
Cardiovascular
17d
Cleared
Jul 10, 1981
CASSETTE READER
Cardiovascular
66d
Cleared
Jul 10, 1981
PAPER CHART RECORDER
Cardiovascular
66d
Cleared
Jul 10, 1981
ARRYTHMIA PRINTER OPTION
Cardiovascular
16d
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