Grason-Stadler, Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Grason-Stadler, Inc. Ear, Nose, Throat ✕
15 devices
Cleared
May 11, 2018
GSI Corti
Ear, Nose, Throat
99d
Cleared
Oct 20, 2017
GSI Novus
Ear, Nose, Throat
72d
Cleared
Apr 12, 2000
GSI 2000 MIDDLE EAR ANALYZER
Ear, Nose, Throat
90d
Cleared
Feb 10, 1998
GSI 70 AUDIOPATH SCREENER
Ear, Nose, Throat
90d
Cleared
Jun 06, 1997
GSI SA60 DPOAE SYSTEM
Ear, Nose, Throat
130d
Cleared
Oct 27, 1995
GSI 61 CLINICAL AUDIOMETER
Ear, Nose, Throat
85d
Cleared
Jul 06, 1995
GSI 65 COMPUTERIZED AUDIOMETER
Ear, Nose, Throat
80d
Cleared
Jul 13, 1990
GSI 17 SCREENING AUDIOMETER
Ear, Nose, Throat
37d
Cleared
Jul 14, 1989
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
Ear, Nose, Throat
184d
Cleared
Nov 03, 1986
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
Ear, Nose, Throat
66d
Cleared
Dec 03, 1984
AUDIOMETER
Ear, Nose, Throat
80d
Cleared
Apr 09, 1982
MIDDLE EAR ANALYZER (IMPEDANCE AUDIO
Ear, Nose, Throat
25d
Cleared
Apr 29, 1981
AUDIOMETER
Ear, Nose, Throat
57d
Cleared
May 17, 1979
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
Ear, Nose, Throat
13d
Cleared
Apr 10, 1979
AUDIOMETER
Ear, Nose, Throat
12d