Blue Torch Medical Technologies
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Blue Torch Medical Technologies makes
Blue Torch Medical Technologies manufactures the CAVERMAP Surgical Aid, a device used in surgical procedures, along with modifications to this surgical aid. These products are designed to assist in specific medical interventions requiring precise surgical support.
The company’s portfolio is regulated under Class I devices in the US, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Cavermap Surgical Aid Ref K041732
Regimes: 510(k) Registry: 510(k)Modification To Cavermap Surgical Aid Ref K031527
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Blue Torch Medical Technologies, initiated on 2003-07-10. By recorded status: 1 terminated. The reasons filed fall into these groups: 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.
2003
- 10 Jul 2003 Z-1235-03 Unclassified (pre-2012) Terminated Product's sterility is compromised due to a failed sterility audit
Frequently asked questions
How many devices does Blue Torch Medical Technologies have in the registry?
The registry currently lists 2 devices for Blue Torch Medical Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Torch Medical Technologies's devices?
Among its 2 most recently registered devices, Blue Torch Medical Technologies has devices listed in FDA 510(k) (2 devices).
What risk classes do Blue Torch Medical Technologies's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Blue Torch Medical Technologies's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Blue Torch Medical Technologies?
FDA recall records list 1 recall initiated by Blue Torch Medical Technologies, the most recent initiated on 2003-07-10. 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 Blue Torch Medical Technologies in the registry?
The most recently registered devices listed for Blue Torch Medical Technologies include CAVERMAP SURGICAL AID and MODIFICATION TO CAVERMAP SURGICAL AID.