GELITA MEDICAL GmbH
Country not established
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 330774063
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 27 Jul 2022 Z-1768-2022 Class II Terminated In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Frequently asked questions
How many devices does GELITA MEDICAL GmbH have in the registry?
The registry currently lists 7 devices for GELITA MEDICAL GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list GELITA MEDICAL GmbH's devices?
Among its 7 most recently registered devices, GELITA MEDICAL GmbH has devices listed in FDA GUDID (7 devices).
What risk classes do GELITA MEDICAL GmbH's devices fall under?
Among its 7 most recently registered devices, the classes recorded for GELITA MEDICAL GmbH's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for GELITA MEDICAL GmbH?
FDA recall records list 1 recall initiated by GELITA MEDICAL GmbH, the most recent initiated on 27 Jul 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from GELITA MEDICAL GmbH in the registry?
The most recently registered devices listed for GELITA MEDICAL GmbH include GELITA-SPON® STANDARD GS-950, GELITA-SPON® STANDARD GS-325, GELITA-SPON® STANDARD GS-015 and GELITA-SPON® STANDARD GS-030.