# Bauer Medical, Inc.

- Location (FDA's records): Clearwater, FL
- FDA decisions: 3 (1994–1996): 3 510(k) clearances
- Product codes: KNW (2), GDF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Biopsybell S.R.L.: 1 (https://510kreport.com/company/biopsybell)
- M.D.L. S.R.L.: 1 (https://510kreport.com/company/mdl)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Inrad: 1 (https://510kreport.com/company/inrad)

## Its most-cited devices
- K960064: Temno Achieve Biopsy Needle (1996), cited by 5

## Recent decisions
- K960065: Temno Double Shot Biopsy Needle (Apr 5, 1996)
- K960064: Temno Achieve Biopsy Needle (Apr 5, 1996)
- K935538: Bauer Temno Coaxial Needle (Feb 22, 1994)

Source page: https://510kreport.com/company/bauer-medical