Medical Device Manufacturer · CA , Oakville, Ontario

Madsen Electronics (Canada) , Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1985
17
Total
17
Cleared
0
Denied

Madsen Electronics (Canada) , Ltd. has 17 FDA 510(k) cleared ear, nose, throat devices. Based in Oakville, Ontario, CA.

Historical record: 17 cleared submissions from 1985 to 1994.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Madsen Electronics (Canada) , Ltd.

17 devices
1-17 of 17
Cleared Jul 18, 1994
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
K942749 · ESD
Ear, Nose, Throat · 38d
Cleared Feb 18, 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325 · EWO
Ear, Nose, Throat · 339d
Cleared Nov 19, 1993
ORBITER 922 CLINICAL AUDIOMETER
K931324 · EWO
Ear, Nose, Throat · 248d
Cleared Jun 19, 1991
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · ETY
Ear, Nose, Throat · 148d
Cleared Feb 13, 1989
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371 · ETW
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372 · ETW
Ear, Nose, Throat · 118d
Cleared Nov 17, 1988
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · EWO
Ear, Nose, Throat · 93d
Cleared Jan 27, 1988
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K874354 · ETY
Ear, Nose, Throat · 96d
Cleared Mar 13, 1987
HEARING AID TEST SYSTEM MODEL HAT 1000
K870229 · ETW
Ear, Nose, Throat · 51d
Cleared Nov 26, 1986
PLOTTER MODEL (MP100)
K861905
Gastroenterology & Urology · 194d
Cleared Sep 30, 1986
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
K854533
Neurology · 321d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535 · ETW
Ear, Nose, Throat · 99d
Cleared Feb 13, 1986
DIGITAL SCREENING AUDIOMETER DSA6214
K854534 · EWO
Ear, Nose, Throat · 92d
Cleared May 29, 1985
UP800 A UNIVERSAL PRINTER
K845050 · EWO
Ear, Nose, Throat · 184d
Cleared May 22, 1985
MTA 86
K844592
Neurology · 177d
Cleared May 21, 1985
Z0174, IMPEDANCE AUDIOMETER
K845049 · ETY
Ear, Nose, Throat · 176d
Cleared Feb 25, 1985
VPS 2250, CSU2250 & VFU 2250
K844659 · GWE
Neurology · 91d
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