Zimmer Elektromedizin GmbH
Neu-Ulm, DE
Zimmer Elektromedizin GmbH appears in FDA device records in Neu-Ulm, DE. 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 Zimmer Elektromedizin GmbH between 1985 and 2008. The busiest year on record is 1985, with 4. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 1 |
| 1993 | 1 |
| 1996 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080735 | CRYOMINI | GEX | Substantially Equivalent | |
| K060395 | CRYO, MODEL V6.0 | GEX | Substantially Equivalent | |
| K040727 | CRYO 5 | GEX | Substantially Equivalent | |
| K960969 | GALVA 5-T | GZJ | Substantially Equivalent | |
| K952536 | SONO 5 | IMI | Substantially Equivalent for Some Indications | |
| K954411 | GALVA-5-M | IPF | Substantially Equivalent for Some Indications | |
| K924473 | DISPOSABLE THERAPY ELECTRODE | GXY | Substantially Equivalent | |
| K860758 | VACO SUCTION ELECTRODE UNIT | IPF | Substantially Equivalent | |
| K850006 | TENS | Substantially Equivalent for Some Indications | ||
| K852166 | THERMO SHORTWAVE DIATHERMY | IMJ | Substantially Equivalent for Some Indications | |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | IPF | Substantially Equivalent | |
| K850454 | CARDIO-3 CHANNEL ELECTROCARDIOGRAPH | DPS | 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