Zimmer Elektromedizin GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Zimmer Elektromedizin GmbH” (first 1985, latest 2008), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Zimmer Elektromedizin GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080735 | CRYOMINI | GEX | 2008-04-04 | 18 |
| K060395 | CRYO, MODEL V6.0 | GEX | 2006-02-24 | 9 |
| K040727 | CRYO 5 | GEX | 2004-04-23 | 32 |
| K960969 | GALVA 5-T | GZJ | 1996-05-15 | 65 |
| K952536 | SONO 5 | IMI | 1996-03-05 | 278 |
| K954411 | GALVA-5-M | IPF | 1996-02-28 | 160 |
| K924473 | DISPOSABLE THERAPY ELECTRODE | GXY | 1993-05-19 | 261 |
| K860758 | VACO SUCTION ELECTRODE UNIT | IPF | 1986-05-02 | 63 |
| K850006 | TENS | — | 1985-12-20 | 352 |
| K852166 | THERMO SHORTWAVE DIATHERMY | IMJ | 1985-09-30 | 133 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zimmer Elektromedizin GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zimmer, Inc. (422 510(k)s)
- Zimmer Spine, Inc. (43 510(k)s)
- Zimmer Dental, Inc. (40 510(k)s)
- Zimmer Biomet Spine, Inc. (15 510(k)s)
- Zimmer Medizinsysteme GmbH (13 510(k)s)
- Zimmer Trabecular Metal Technology (13 510(k)s)
- Zimmer Trabecular (10 510(k)s)
- Zimmer Biomet (5 510(k)s)
- Zimmer Switzerland Manufacturing GmbH (4 510(k)s)
- Zimmer Cas (3 510(k)s)
- Zimmer Patient Care Division (3 510(k)s)
- Zimmer Austin, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zimmer Elektromedizin GmbH?
FDA lists 12 510(k) clearances under the applicant name “Zimmer Elektromedizin GmbH” (first 1985, latest 2008), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zimmer Elektromedizin GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Elektromedizin GmbH is 78 days.
Which FDA product codes appear under Zimmer Elektromedizin GmbH?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); IPF (Stimulator, Muscle, Powered, 3); DPS (Electrocardiograph, 1).
Next steps
- See all 12 Zimmer Elektromedizin GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEX, Zimmer Elektromedizin GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.