Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Edwards Laboratories

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K801552 MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORKRB1980-07-28 View
510(k) K800655 MODEL 100 SPECTRAVIEWDQC1980-04-16 View
510(k) K792441 CARPENTIER-EDWARDS FLEX. ANNULOPLASTYKRH1980-03-17 View
510(k) K792034 INTEGRAL DISPOSABLE HOLDER CARPENTIERDTJ1979-12-07 View
510(k) K790047 CARDIAC OUTPUT COMPUTER, MDEL 9520ADXG1979-02-26 View
510(k) K790022 DISPOSABLE HOLDER FOR BIOPROSTHESISDTJ1979-01-15 View
510(k) K781535 AC ADAPTER:MODELS 9525,9526,9527DXG1978-09-15 View
510(k) K771663 PROBE & CATHETERKRB1977-09-20 View
510(k) K771046 VENA CAVA UMBRELLA FILTER, MODEL 7321DTK1977-06-22 View
510(k) K760151 APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)DTK1976-08-26 View
510(k) K760152 FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)DTK1976-07-19 View
510(k) K760192 COMPUTER, THERMODILUTION CARDIAC (9520)DXG1976-07-19 View
↑