Creganna Medical Devices
Country not established
- Devices
- 1
- FDA recalls
- 51 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Creganna Medical Devices makes
Creganna Medical Devices manufactures the Creganna-TactX steerable sheath set symmetric.
The company is based in the US, and its portfolio includes Class II devices that are listed in the FDA 510(k) registry.
Catalogue
Creganna-Tactx Steerable Sheath Set Symmetric Ref K131079
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Creganna Medical Devices, the earliest on 2017-05-22 and the most recent on 2023-06-22. By recorded status: 1 ongoing and 4 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. 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 4
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 22 Jun 2023 Z-2249-2023 Class II Ongoing Three lots of product may be labeled with an incorrect expiration day
2017
- 22 May 2017 Z-2529-2017 Class II Terminated Lack of sterility assurance.
- 22 May 2017 Z-2530-2017 Class II Terminated Lack of sterility assurance.
- 22 May 2017 Z-2531-2017 Class II Terminated Lack of sterility assurance.
- 22 May 2017 Z-2532-2017 Class II Terminated Lack of sterility assurance.
Frequently asked questions
How many devices does Creganna Medical Devices have in the registry?
The registry currently lists 1 device for Creganna Medical Devices. Devices recorded under merged duplicate company entries are counted once.
Which registries list Creganna Medical Devices's devices?
Among its 1 most recently registered device, Creganna Medical Devices has devices listed in FDA 510(k) (1 device).
What risk classes do Creganna Medical Devices's devices fall under?
Among its 1 most recently registered device, the classes recorded for Creganna Medical Devices's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Creganna Medical Devices?
FDA recall records list 5 recalls initiated by Creganna Medical Devices, the most recent initiated on 22 Jun 2023. 1 of them is recorded as ongoing. 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 Creganna Medical Devices in the registry?
The most recently registered devices listed for Creganna Medical Devices include CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC.