Company ยท US
Edwards Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1980. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 1980 | K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR Edwards Laboratories | KRB |
| Apr 16, 1980 | K800655 | MODEL 100 SPECTRAVIEW Edwards Laboratories | DQC |
| Mar 17, 1980 | K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY Edwards Laboratories | KRH |
| Dec 7, 1979 | K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER Edwards Laboratories | DTJ |
| Feb 26, 1979 | K790047 | CARDIAC OUTPUT COMPUTER, MDEL 9520A Edwards Laboratories | DXG |
| Jan 15, 1979 | K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS Edwards Laboratories | DTJ |
| Sep 15, 1978 | K781535 | AC ADAPTER:MODELS 9525,9526,9527 Edwards Laboratories | DXG |
| Sep 20, 1977 | K771663 | PROBE & CATHETER Edwards Laboratories | KRB |
| Jun 22, 1977 | K771046 | VENA CAVA UMBRELLA FILTER, MODEL 7321 Edwards Laboratories | DTK |
| Aug 26, 1976 | K760151 | APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) Edwards Laboratories | DTK |
| Jul 19, 1976 | K760192 | COMPUTER, THERMODILUTION CARDIAC (9520) Edwards Laboratories | DXG |
| Jul 19, 1976 | K760152 | FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) Edwards Laboratories | DTK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||