# Astra Meditec AB

- Location (FDA's records): Sweden, SE
- FDA decisions: 3 (1988–1993): 3 510(k) clearances
- Product codes: DZE (1), GCY (1), KOD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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
- Astra Tech, Inc.: 4 (https://510kreport.com/company/astra-tech)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)
- Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.: 1 (https://510kreport.com/company/oasis-medikal-urunler-kimya-sanayi-ve-tic)

## Its most-cited devices
- K896750: Lofric (R), Lofric (R) Cath-Kit (1990), cited by 6

## Recent decisions
- K920819: Abdovac (TM), Bellovac (TM) and Exudrain (Mar 24, 1993)
- K896750: Lofric (R), Lofric (R) Cath-Kit (Aug 6, 1990)
- K882578: Astra Dental Implant System (Aug 12, 1988)

Source page: https://510kreport.com/company/astra-meditec