# Medelec Intl. Corp.

- Location (FDA's records): Miami Beach, FL
- FDA decisions: 15 (1985–1996): 15 510(k) clearances
- Product codes: GES (3), GWQ (2), HIS (2), GDZ (1), IKT (1), GDX (1), BRZ (1), GWF (1), JKA (1), FMF (1), JXE (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
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Carefusion 209, Inc.: 1 (https://510kreport.com/company/carefusion-209)
- Spes Medica Srl: 1 (https://510kreport.com/company/spes-medica)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)

## Its most-cited devices
- K961013: Disposable Needle Electrode (1996), cited by 4

## Recent decisions
- K961013: Disposable Needle Electrode (Dec 20, 1996)
- K935017: TD50 Electromyograph (Jul 28, 1994)
- K922548: Medelec 2110 and 2114 Eeg (Nov 3, 1992)
- K920127: Electroencephalograph Recording System (Jun 10, 1992)
- K912775: Sapphire 4ME Emg/EP System (Nov 8, 1991)
- K865106: Prophylactic (Condom) MR. Johnny (May 20, 1987)
- K863491: Blood Specimen Collection Devices (Oct 24, 1986)
- K854622: Prophylactic (Condom) (Apr 11, 1986)

Source page: https://510kreport.com/company/medelec-intl