Edwards Pacemaker Systems
Mchenry, IL, US
Edwards Pacemaker Systems appears in FDA device records in Mchenry, IL. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Edwards Pacemaker Systems between 1977 and 1979. The busiest year on record is 1978, with 6. The most recent is 1979, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 5 |
| 1978 | 6 |
| 1979 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | DXY | Substantially Equivalent | |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | DXY | Substantially Equivalent | |
| K781111 | LEAD CONVERSION KIT, MODEL 341 | Substantially Equivalent | ||
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | DTC | Substantially Equivalent | |
| K781042 | PROLITH 23S PACEMAKER | DXY | Substantially Equivalent | |
| K780780 | MICROPULSE 22S PACEMAKER | DXY | Substantially Equivalent | |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | DXY | Substantially Equivalent | |
| K780091 | MICROPULSE 22U | DXY | Substantially Equivalent | |
| K771987 | MICROPULSE 26U PULSE GENERATOR | DXY | Substantially Equivalent | |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | DXY | Substantially Equivalent | |
| K770656 | GENERATOR, PULSE, CARDIAC 20U | DXY | Substantially Equivalent | |
| K770212 | PROLITH MODEL 21S CARDIAC PULSE GEN. | DXY | Substantially Equivalent | |
| K770211 | MICROPULSE MODEL 20S | DXY | 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