Edwards Laboratories
Mchenry, IL, US
Edwards Laboratories appears in FDA device records in Mchenry, IL. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Edwards Laboratories between 1976 and 1980. The busiest year on record is 1976, with 3. The most recent is 1980, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR | KRB | Substantially Equivalent | |
| K800655 | MODEL 100 SPECTRAVIEW | DQC | Substantially Equivalent | |
| K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY | KRH | Substantially Equivalent - Subject to Tracking & PMS | |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | DTJ | Substantially Equivalent | |
| K790047 | CARDIAC OUTPUT COMPUTER, MDEL 9520A | DXG | Substantially Equivalent | |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | DTJ | Substantially Equivalent | |
| K781535 | AC ADAPTER:MODELS 9525,9526,9527 | DXG | Substantially Equivalent | |
| K771663 | PROBE & CATHETER | KRB | Substantially Equivalent | |
| K771046 | VENA CAVA UMBRELLA FILTER, MODEL 7321 | DTK | Substantially Equivalent | |
| K760151 | APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) | DTK | Substantially Equivalent | |
| K760192 | COMPUTER, THERMODILUTION CARDIAC (9520) | DXG | Substantially Equivalent | |
| K760152 | FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) | DTK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain