Fetzer Medical GmbH & Co. KG
GermanyFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Fetzer Medical GmbH & Co. KG makes
Fetzer Medical GmbH & Co. KG manufactures gynecological forceps, vessel dilators, and self-retaining retractors for surgical procedures. These instruments are designed for precision handling and stabilization in minimally invasive and open surgical applications.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The manufacturer is based in the United States.
Catalogue
Fetzer Medical Gynecological Forceps Ref K172661
Regimes: 510(k) Registry: 510(k)Vessel Dilator Ref K163524
Regimes: 510(k) Registry: 510(k)Self-retaining Retractor Ref K161004
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Fetzer Medical GmbH & Co. KG, initiated on 2018-12-28. By recorded status: 4 terminated. The reasons filed fall into these groups: other reasons as filed. 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 4
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 28 Dec 2018 Z-0755-2019 Class II Terminated The firm had a report of doctors being unable to pull the obstetric forceps apart.
- 28 Dec 2018 Z-0756-2019 Class II Terminated The firm had a report of doctors being unable to pull the obstetric forceps apart.
- 28 Dec 2018 Z-0757-2019 Class II Terminated The firm had a report of doctors being unable to pull the obstetric forceps apart.
- 28 Dec 2018 Z-0758-2019 Class II Terminated The firm had a report of doctors being unable to pull the obstetric forceps apart.
FDA establishments
- Fetzer Medical GmbH & Co.kg Tuttlingen Baden-Wurttemberg · DE FEI 3007648354
Frequently asked questions
How many devices does Fetzer Medical GmbH & Co. KG have in the registry?
The registry currently lists 3 devices for Fetzer Medical GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fetzer Medical GmbH & Co. KG's devices?
Among its 3 most recently registered devices, Fetzer Medical GmbH & Co. KG has devices listed in FDA 510(k) (3 devices).
What risk classes do Fetzer Medical GmbH & Co. KG's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Fetzer Medical GmbH & Co. KG's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fetzer Medical GmbH & Co. KG?
FDA recall records list 4 recalls initiated by Fetzer Medical GmbH & Co. KG, the most recent initiated on 28 Dec 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 Fetzer Medical GmbH & Co. KG in the registry?
The most recently registered devices listed for Fetzer Medical GmbH & Co. KG include Fetzer Medical Gynecological Forceps, Vessel Dilator and Self-retaining Retractor.
Which FDA establishments are linked to Fetzer Medical GmbH & Co. KG?
1 FDA establishment is linked to Fetzer Medical GmbH & Co. KG in the registry; they are listed on the company page.