# Amedic USA

- Location (FDA's records): Phoenix, AZ
- FDA decisions: 10 (1987–1990): 10 510(k) clearances
- Product codes: FCG (2), HGL (2), JOT (1), KNW (1), KKX (1), FZX (1), ITX (1), FFF (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K897120: Equip Covers, Sterile (Jan 4, 1990)
- K892070: General Ivt Needle Guide Kit, Sterile (Sep 5, 1989)
- K892071: General (Biopsy) Needle Guide Kit, Sterile (Aug 8, 1989)
- K892069: Extended Covers, Sterile (Aug 8, 1989)
- K892068: TRT (Acuson) Needle Guide Kit, Sterile (Aug 4, 1989)
- K871467: Biopsy Needle Guide Kit, Sterile (Aug 21, 1987)
- K871565: Ultrasound Transducer Gel, Sterile (Jul 15, 1987)
- K871609: Ultrasound Transducer Sheaths, Sterile (Jul 15, 1987)

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