# F.M. Wiest USA, Inc.

- Location (FDA's records): Oradell, NJ
- FDA decisions: 12 (1986–1994): 12 510(k) clearances
- Product codes: HRX (3), HIG (2), FAP (2), EZN (1), EXQ (1), HIF (1), HES (1), IKN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (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
- Andromeda Medizinische Systeme GmbH: 2 (https://510kreport.com/company/andromeda-medizinische-systeme)
- Circon Video: 1 (https://510kreport.com/company/circon-video)
- Dantec Medical, Inc.: 1 (https://510kreport.com/company/dantec-medical)

## Its most-cited devices
- K920575: Merkur 4000 (1992), cited by 2
- K912071: Space (TM) 7500 (1991), cited by 1
- K860571: F.M. Weist,KG (Urodynamic Systems) (1986), cited by 1

## Recent decisions
- K921871: Hysteromat (TM) 3700 (Dec 15, 1994)
- K920574: Camsys 6300 (Feb 17, 1993)
- K920575: Merkur 4000 (Jul 23, 1992)
- K915751: Ureteromat 4400 (Apr 24, 1992)
- K911844: Hysteroflator 1500 (Nov 21, 1991)
- K912071: Space (TM) 7500 (Jul 9, 1991)
- K910883: Laparoflator Electronic 3509 (Mar 29, 1991)
- K875137: Laparoflator 3000, Standard and Electronic (Mar 2, 1988)

Source page: https://510kreport.com/company/fm-wiest-usa