Medical Device Manufacturer · US , Mchenry , IL

Grason-Stadler, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1979

Total

Cleared

Denied

Grason-Stadler, Inc. has 16 FDA 510(k) cleared ear, nose, throat devices. Based in Mchenry, US.

Historical record: 16 cleared submissions from 1979 to 2018.

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 - Grason-Stadler, Inc.

16 devices

1-12 of 16

Cleared May 11, 2018

GSI Corti

K180287 · EWO

Ear, Nose, Throat · 99d

Cleared Oct 20, 2017

GSI Novus

K172403 · EWO

Ear, Nose, Throat · 72d

Cleared Apr 12, 2000

GSI 2000 MIDDLE EAR ANALYZER

K000097 · ETY

Ear, Nose, Throat · 90d

Cleared Feb 10, 1998

GSI 70 AUDIOPATH SCREENER

K974237 · EWO

Ear, Nose, Throat · 90d

Cleared Jun 06, 1997

GSI SA60 DPOAE SYSTEM

K970324 · ETW

Ear, Nose, Throat · 130d

Cleared Oct 27, 1995

GSI 61 CLINICAL AUDIOMETER

K953684 · EWO

Ear, Nose, Throat · 85d

Cleared Jul 06, 1995

GSI 65 COMPUTERIZED AUDIOMETER

K951759 · EWO

Ear, Nose, Throat · 80d

Cleared Jul 13, 1990

GSI 17 SCREENING AUDIOMETER

K902540 · EWO

Ear, Nose, Throat · 37d

Cleared Jul 14, 1989

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER

K890124 · EWO

Ear, Nose, Throat · 184d

Cleared Mar 13, 1987

THE SCREENER GSI 55 ABR SCREENER

K870030 · GWJ

Neurology · 67d

Cleared Nov 03, 1986

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)

K863353 · ETY

Ear, Nose, Throat · 66d

Cleared Dec 03, 1984

AUDIOMETER

K843618 · EWO

Ear, Nose, Throat · 80d

Grason-Stadler, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Grason-Stadler, Inc.

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