DANNORITZER Medizintechnik GmbH & Co. KG
Country not established
- Devices
- 2,001
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What DANNORITZER Medizintechnik GmbH & Co. KG makes
DANNORITZER Medizintechnik GmbH & Co. KG manufactures spinal rongeurs, including the DANmed line, as well as monopolar laparoscopic accessories for surgical procedures.
These devices are classified as Class II under regulatory frameworks, with submissions recorded in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Catalogue
Search and filter all 2,001 devicesShowing 1-50 of 2,001
Company details
- DUNS number
- 314648911
- [email protected]
- Phone
- +497461962390
FDA recalls
FDA recall records list 1 recall initiated by DANNORITZER Medizintechnik GmbH & Co. KG, initiated on 2018-08-06. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 6 Aug 2018 Z-0062-2019 Class III Terminated The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
Frequently asked questions
How many devices does DANNORITZER Medizintechnik GmbH & Co. KG have in the registry?
The registry currently lists 2001 devices for DANNORITZER Medizintechnik GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list DANNORITZER Medizintechnik GmbH & Co. KG's devices?
Among its 50 most recently registered devices, DANNORITZER Medizintechnik GmbH & Co. KG has devices listed in FDA GUDID (50 devices).
What risk classes do DANNORITZER Medizintechnik GmbH & Co. KG's devices fall under?
Among its 50 most recently registered devices, the classes recorded for DANNORITZER Medizintechnik GmbH & Co. KG's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for DANNORITZER Medizintechnik GmbH & Co. KG?
FDA recall records list 1 recall initiated by DANNORITZER Medizintechnik GmbH & Co. KG, the most recent initiated on 6 Aug 2018. 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 DANNORITZER Medizintechnik GmbH & Co. KG in the registry?
The most recently registered devices listed for DANNORITZER Medizintechnik GmbH & Co. KG include DANmed LMC-148-445, DANmed LMB-213-045, DANmed LMQ-125-145 and DANmed LMC-119-525.