Tenet Medical Engineering
CanadaFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Tenet Medical Engineering makes
Tenet Medical Engineering manufactures orthopedic and surgical positioning devices, including the TENET Tibial Fracture Support for stabilizing leg fractures, the Multi-Positioning Surgical Stirrup System for limb immobilization during procedures, and the Radiolucent Hand Table for imaging-compatible hand surgery support.
Their portfolio includes Class I and Class II devices, with records submitted under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Tenet Tibial Fracture Support Ref K964102
Regimes: 510(k) Registry: 510(k)Tenet Mlti-Positioning Surgical Stirrup System Ref K963505
Regimes: 510(k) Registry: 510(k)Tenet Radiolucent Hand Table Ref K963506
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Tenet Medical Engineering, initiated on 2007-11-23. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 23 Nov 2007 Z-0577-2008 Unclassified (pre-2012) Terminated Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
- 23 Nov 2007 Z-0578-2008 Unclassified (pre-2012) Terminated Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
- 23 Nov 2007 Z-0579-2008 Unclassified (pre-2012) Terminated Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
Frequently asked questions
How many devices does Tenet Medical Engineering have in the registry?
The registry currently lists 3 devices for Tenet Medical Engineering. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tenet Medical Engineering's devices?
Among its 3 most recently registered devices, Tenet Medical Engineering has devices listed in FDA 510(k) (3 devices).
What risk classes do Tenet Medical Engineering's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Tenet Medical Engineering's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Tenet Medical Engineering?
FDA recall records list 3 recalls initiated by Tenet Medical Engineering, the most recent initiated on 23 Nov 2007. 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 Tenet Medical Engineering in the registry?
The most recently registered devices listed for Tenet Medical Engineering include TENET TIBIAL FRACTURE SUPPORT, TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM and TENET RADIOLUCENT HAND TABLE.