Edwards Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORJuly 28, 1980
K800655MODEL 100 SPECTRAVIEWApril 16, 1980
K792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYMarch 17, 1980
K792034INTEGRAL DISPOSABLE HOLDER CARPENTIERDecember 7, 1979
K790047CARDIAC OUTPUT COMPUTER, MDEL 9520AFebruary 26, 1979
K790022DISPOSABLE HOLDER FOR BIOPROSTHESISJanuary 15, 1979
K781535AC ADAPTER:MODELS 9525,9526,9527September 15, 1978
K771663PROBE & CATHETERSeptember 20, 1977
K771046VENA CAVA UMBRELLA FILTER, MODEL 7321June 22, 1977
K760151APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)August 26, 1976
K760192COMPUTER, THERMODILUTION CARDIAC (9520)July 19, 1976
K760152FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)July 19, 1976