Laax, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Laax, Inc. makes
Laax, Inc. manufactures the TIGERPAW SYSTEM II and TIGERPAW SYSTEM, which are medical devices designed for orthopedic applications, including internal fixation solutions for bone stabilization.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Tigerpaw System Ii Ref K111064
Regimes: 510(k) Registry: 510(k)Tigerpaw System Ref K101961
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Laax, Inc., initiated on 2015-03-25. By recorded status: 2 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.
2015
- 25 Mar 2015 Z-1461-2015 Class I Terminated Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Full distribution text
- 25 Mar 2015 Z-1462-2015 Class I Terminated Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Full distribution text
- 25 Mar 2015 Z-1461-2015 Class I Terminated Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Frequently asked questions
How many devices does Laax, Inc. have in the registry?
The registry currently lists 2 devices for Laax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Laax, Inc.'s devices?
Among its 2 most recently registered devices, Laax, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Laax, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Laax, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Laax, Inc.?
FDA recall records list 2 recalls initiated by Laax, Inc., the most recent initiated on 25 Mar 2015. 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 Laax, Inc. in the registry?
The most recently registered devices listed for Laax, Inc. include TIGERPAW SYSTEM II and TIGERPAW SYSTEM.