Madsen Electronics (Canada) , Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Madsen Electronics (Canada) , Ltd.” (first 1985, latest 1994), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 118 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 5 | 5 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 4 | 4 |
| ETY | Tester, Auditory Impedance | 3 | 3 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (13)
- Neurology (1)
Most recent Madsen Electronics (Canada) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942749 | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT | ESD | 1994-07-18 | 38 |
| K931325 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 | EWO | 1994-02-18 | 339 |
| K931324 | ORBITER 922 CLINICAL AUDIOMETER | EWO | 1993-11-19 | 248 |
| K910247 | ZODIAC 901 MIDDLE-EAR ANALYZER | ETY | 1991-06-19 | 148 |
| K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER | ETW | 1989-02-13 | 118 |
| K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM | ETW | 1989-02-13 | 118 |
| K883478 | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 | EWO | 1988-11-17 | 93 |
| K874354 | AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 | ETY | 1988-01-27 | 96 |
| K870229 | HEARING AID TEST SYSTEM MODEL HAT 1000 | ETW | 1987-03-13 | 51 |
| K861905 | PLOTTER MODEL (MP100) | — | 1986-11-26 | 194 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Madsen Electronics (Canada) , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Madsen Electronics, Inc. (4 510(k)s)
- Madsen North America, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Madsen Electronics (Canada) , Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Madsen Electronics (Canada) , Ltd.” (first 1985, latest 1994), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Madsen Electronics (Canada) , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Madsen Electronics (Canada) , Ltd. is 118 days.
Which FDA product codes appear under Madsen Electronics (Canada) , Ltd.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 5); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 4); ETY (Tester, Auditory Impedance, 3).
Next steps
- See all 17 Madsen Electronics (Canada) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Madsen Electronics (Canada) , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.