Dufner Instrumente GmbH
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Dufner Instrumente GmbH makes
Dufner Instrumente GmbH manufactures MICTEC endoscopes and their associated accessories, which are used for diagnostic and therapeutic procedures in medical imaging and intervention.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Mictec Endoscopes And Accessories Ref K002877
510(k) 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 3 Jun 2020 Z-2534-2020 Class II Terminated Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
FDA establishments
- Dufner Instrumente GmbH TUTTLINGEN Baden-Wurttemberg · DE FEI 3002806862
Frequently asked questions
How many devices does Dufner Instrumente GmbH have in the registry?
The registry currently lists 1 device for Dufner Instrumente GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dufner Instrumente GmbH's devices?
Among its 1 most recently registered device, Dufner Instrumente GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Dufner Instrumente GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Dufner Instrumente GmbH's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Dufner Instrumente GmbH?
FDA recall records list 1 recall initiated by Dufner Instrumente GmbH, the most recent initiated on 2020-06-03. 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 Dufner Instrumente GmbH in the registry?
The most recently registered devices listed for Dufner Instrumente GmbH include MICTEC ENDOSCOPES AND ACCESSORIES.
Which FDA establishments are linked to Dufner Instrumente GmbH?
1 FDA establishment is linked to Dufner Instrumente GmbH in the registry; they are listed on the company page.