Company ยท DE
Zimmer Medizinsysteme GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 6 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 |
| GEX | Powered Laser Surgical Instrument | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 |
| IPF | Stimulator, Muscle, Powered | 1 |
| ITH | Equipment, Traction, Powered | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K253408 | CoolTone Zimmer Medizinsysteme GmbH, DE | NGX |
| Jul 14, 2025 | K251378 | CoolTone Zimmer Medizinsysteme GmbH, DE | NGX |
| Jul 21, 2024 | K240347 | PTG-05 Zimmer Medizinsysteme GmbH, DE | NGX |
| Jul 15, 2024 | K240178 | RFG-01 Zimmer Medizinsysteme GmbH, DE | PBX |
| Oct 5, 2023 | K230780 | MFG-05 Zimmer Medizinsysteme GmbH, DE | KPI |
| May 25, 2023 | K213256 | ThermoTK Zimmer Medizinsysteme GmbH, DE | PBX |
| May 16, 2023 | K222912 | c1Trac Zimmer Medizinsysteme GmbH, DE | ITH |
| Apr 1, 2022 | K220601 | CoolTone Zimmer Medizinsysteme GmbH, DE | NGX |
| Feb 4, 2022 | K220020 | Cryo 7 Zimmer Medizinsysteme GmbH, DE | GEX |
| Feb 19, 2021 | K203488 | emField Zimmer Medizinsysteme GmbH, DE | IPF |
| Nov 15, 2019 | K192940 | CoolTone Zimmer Medizinsysteme GmbH, DE | NGX |
| Jun 21, 2019 | K182963 | emFieldPro Zimmer Medizinsysteme GmbH, DE | NGX |
| Nov 14, 2016 | K161862 | ThermoPro Zimmer Medizinsysteme GmbH, DE | IMJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||