Zimmer Medizinsysteme GmbH
NEU-ULM Bavaria, DE
ZIMMER MEDIZINSYSTEME GMBH appears in FDA device records in NEU-ULM Bavaria, DE. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Zimmer Medizinsysteme GmbH between 2016 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253408 | CoolTone | NGX | Substantially Equivalent | |
| K251378 | CoolTone | NGX | Substantially Equivalent | |
| K240347 | PTG-05 | NGX | Substantially Equivalent | |
| K240178 | RFG-01 | PBX | Substantially Equivalent | |
| K230780 | MFG-05 | KPI | Substantially Equivalent | |
| K213256 | ThermoTK | PBX | Substantially Equivalent | |
| K222912 | c1Trac | ITH | Substantially Equivalent | |
| K220601 | CoolTone | NGX | Substantially Equivalent | |
| K220020 | Cryo 7 | GEX | Substantially Equivalent | |
| K203488 | emField | IPF | Substantially Equivalent | |
| K192940 | CoolTone | NGX | Substantially Equivalent | |
| K182963 | emFieldPro | NGX | Substantially Equivalent | |
| K161862 | ThermoPro | IMJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010720 | 7759 | ZIMMER MEDIZINSYSTEME GMBH | JUNKERSSTRASSE 9, NEU-ULM Bavaria 89231 DE | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- ITHEquipment, Traction, Powered
- LIHInterferential Current Therapy
- ILYLamp, Infrared, Therapeutic Heating
- ISAMassager, Therapeutic, Electric
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- IMEPack, Hot Or Cold, Reusable
- GEXPowered Laser Surgical Instrument
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain