ERA · Class I · 21 CFR 874.4770

FDA Product Code ERA: Otoscope

Leading manufacturers include Welch Allyn, Inc., Rudolf Riester GmbH & Co. KG and Jedmed Instrument Co..

56
Total
56
Cleared
102d
Avg days
1977
Since
56 devices
25–48 of 56
Cleared Oct 08, 1993
RI-MINI
K932503
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d
Cleared Oct 08, 1993
RI-STAR
K932505
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d
Cleared Oct 08, 1993
RI-SCOPE (S)
K932506
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d
Cleared Aug 03, 1993
OTOSCOPE
K925758
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 263d
Cleared Jul 26, 1993
UNI I
K925759
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 255d
Cleared Nov 09, 1992
XOMED-TREACE ALPHASCOPE
K923830
Xomed-Treace, Inc.
Ear, Nose, Throat · 101d
Cleared Nov 06, 1992
OTO-BRITE HANDLE
K924025
Jedmed Instrument Co.
Ear, Nose, Throat · 87d
Cleared Oct 21, 1992
FAMILY EAR SCOPE MODEL 29001S
K923304
Ear Care of So. Ca., Inc.
Ear, Nose, Throat · 107d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Apr 23, 1992
OPTIEAR
K920322
Nankivell Industries, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 24, 1992
EARBEAR OTOSCOPE
K915537
Earbear Co.
Ear, Nose, Throat · 45d
Cleared Oct 17, 1991
PEDIA PALS
K911650
Pedia Pals, Inc.
Ear, Nose, Throat · 188d
Cleared Apr 30, 1991
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K904659
Panex Corp.
Ear, Nose, Throat · 197d
Cleared Jan 22, 1991
VIDEO OTOSCOPE
K904802
Jedmed Instrument Co.
Ear, Nose, Throat · 90d
Cleared Aug 14, 1990
OTOSCOPE
K902205
Truphatek, Ltd.
Ear, Nose, Throat · 90d
Cleared Jan 26, 1990
TYMPANOSCOPE
K896274
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Aug 08, 1986
D.L. SCOPE(R) OTOSCOPE
K862661
North American Medical Products, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 01, 1986
I22 INITIALES
K862621
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
I81 CITE
K862624
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 29, 1985
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745
Artiberia
Ear, Nose, Throat · 126d
Cleared May 29, 1985
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
K851746
Artiberia
Ear, Nose, Throat · 34d
Cleared Jul 13, 1984
DISPOSA-SPEC
K840593
Plasti-Products, Inc.
Ear, Nose, Throat · 155d
Cleared Aug 12, 1983
INSPETOSCOPE
K831614
Terayco Intl., Ltd.
Ear, Nose, Throat · 85d
Cleared Jun 30, 1983
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709
Welch Allyn, Inc.
Ear, Nose, Throat · 35d