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American Edwards Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
89
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K873485EDSLAB (R) OCCLUSION BALLOON CATHETERDecember 3, 1987
K872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30September 30, 1987
K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2September 15, 1987
K870444HOMEPRO II VOLUMETRIC INFUSION PUMPApril 17, 1987
K864997MEDTRAC VP VOLUMETRIC INFUSION PUMPFebruary 27, 1987
K864330SHEAR FORCE GAUGEJanuary 6, 1987
K862724VEIN VALVE CUTTERJanuary 2, 1987
K863596CHIN-FOGARTY INFLATION DEVICENovember 20, 1986
K864155MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESISNovember 20, 1986
K863986XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURESOctober 31, 1986
K862872FLEXIBLE VISUALIZATION CATHETEROctober 24, 1986
K863605ARTHROSCOPIC IRRIGATION PUMPOctober 3, 1986
K863604DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICEOctober 3, 1986
K863598VIDEO CAMERA SYSTEMOctober 2, 1986
K863696ARTHROSCOPIC SURGICAL POWER DEVICESeptember 29, 1986
K863597AMERICAN EDWARDS 4.0 MM ARTHROSCOPESeptember 25, 1986
K862547MECHANICAL INFLATION DEVICESeptember 3, 1986
K855000RATEMINDER III INFUSION DEVICEFebruary 12, 1986
K853514RIGID ENDOSCOPEOctober 4, 1985
K853337TROCAR/CANNULA/SHEATH SETAugust 23, 1985