# Andromeda Medizinische Systeme GmbH

- Location (FDA's records): Potomac, MD
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: FEN (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- F.M. Wiest USA, Inc.: 2 (https://510kreport.com/company/fm-wiest-usa)

## Recent decisions
- K964522: Ellipse 4 (Mar 21, 1997)

Source page: https://510kreport.com/company/andromeda-medizinische-systeme