# Madsen Electronics (Canada), Ltd.

- Location (FDA's records): Oakville, Ontario, CA
- FDA decisions: 17 (1985–1994): 17 510(k) clearances
- Product codes: EWO (5), ETW (4), ETY (3), ESD (1), GWE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (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
- Cochlear Bone Anchored Systems AB: 1 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Tympany, Inc.: 1 (https://510kreport.com/company/tympany)
- Gn Otometrics A/S: 1 (https://510kreport.com/company/gn-otometrics-a-s)

## Its most-cited devices
- K910247: Zodiac 901 Middle-Ear Analyzer (1991), cited by 2
- K942749: HI-Pro/Noah Universal Hearing Instrument (1994), cited by 1

## Recent decisions
- K942749: HI-Pro/Noah Universal Hearing Instrument (Jul 18, 1994)
- K931325: Otoacoustic Emissions Unit Celesta 503 (Feb 18, 1994)
- K931324: Orbiter 922 Clinical Audiometer (Nov 19, 1993)
- K910247: Zodiac 901 Middle-Ear Analyzer (Jun 19, 1991)
- K884372: Madsen IGO1500 Insertion Gain Optimizer (Feb 13, 1989)
- K884371: Madsen Igo-HAT1500 Hearing Aid Dispenser System (Feb 13, 1989)
- K883478: Diagnostic Audiometer, Model Midimate 602 (Nov 17, 1988)
- K874354: Audiometric Impedance Tester, Model Z02020 (Jan 27, 1988)

Source page: https://510kreport.com/company/madsen-electronics-canada