American Edwards Laboratories - FDA 510(k) Cleared Devices
89
Total
88
Cleared
0
Denied
89 devices
Cleared
Nov 29, 1983
COAXIAL BALLOON URETHRAL DILATOR
Gastroenterology & Urology
42d
Cleared
Nov 03, 1983
ANGIOSCOPY CATHETER
Cardiovascular
85d
Cleared
Sep 29, 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
Cardiovascular
65d
Cleared
Sep 29, 1983
FOGARTY 6MM SOFTJAW CLIP
Cardiovascular
59d
Cleared
Aug 12, 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
Cardiovascular
81d
Cleared
Aug 11, 1983
EDSLAB PRESSURE GAUGE
Cardiovascular
27d
Not Cleared
Jul 29, 1983
PROSTHETIC RINGS #4400 MITRAL & 4500
Cardiovascular
43d
Cleared
Jun 17, 1983
URETERAL STONE EXTRACTOR CATHETER
Gastroenterology & Urology
60d
Cleared
Jun 15, 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
Cardiovascular
86d
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 31, 1981
VOLUMETRIC INFUSION PUMP
General Hospital
11d
Cleared
Jul 28, 1981
CARDIAC 1000 TM
Radiology
98d
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
Looking for a specific device from American Edwards Laboratories? Search by device name or K-number.
Search all American Edwards... devices