Bauer Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bauer Medical, Inc. makes
Bauer Medical, Inc. manufactures biopsy needles for medical imaging and diagnostic procedures, including the TEMNO Double Shot Biopsy Needle, TEMNO Achieve Biopsy Needle, and Bauer Temno Coaxial Needle. These devices are designed for obtaining tissue samples during procedures such as breast and soft-tissue biopsies.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Temno Double Shot Biopsy Needle Ref K960065
Regimes: 510(k) Registry: 510(k)Temno Achieve Biopsy Needle Ref K960064
Regimes: 510(k) Registry: 510(k)Bauer Temno Coaxial Needle Ref K935538
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bauer Medical, Inc. have in the registry?
The registry currently lists 3 devices for Bauer Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bauer Medical, Inc.'s devices?
Among its 3 most recently registered devices, Bauer Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bauer Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bauer Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bauer Medical, Inc. in the registry?
The most recently registered devices listed for Bauer Medical, Inc. include TEMNO DOUBLE SHOT BIOPSY NEEDLE, TEMNO ACHIEVE BIOPSY NEEDLE and BAUER TEMNO COAXIAL NEEDLE.