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

FDA 510(k) Cleared Otoscope Devices (Product Code ERA)

56 devices
1–24 of 56
Cleared May 17, 2013
AIO HD OTOSCOPE
K123821
Blue Focus
Ear, Nose, Throat · 156d
Cleared Jan 25, 2013
LANTOS 3D EAR SCANNER
K121326
Lantos Technologies
Ear, Nose, Throat · 268d
Cleared Oct 27, 2011
OSRAM ITOS
K110326
Osram Sylvania, Inc.
Ear, Nose, Throat · 266d
Cleared Feb 02, 1996
OPTUS OTOSCOPES
K945264
Optus, Inc.
Ear, Nose, Throat · 462d
Cleared Nov 14, 1995
WELCH ALLYN BI-OTOSCOPE
K955043
Welch Allyn, Inc.
Ear, Nose, Throat · 11d
Cleared Jul 10, 1995
WELCH ALLY OTOSCOPE
K952578
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared May 12, 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 78d
Cleared May 03, 1995
OTOSCOPE A-34
K950788
Neitz Instruments Company, Ltd.
Ear, Nose, Throat · 71d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951049
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951050
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 13, 1995
IMEDGE VIDEO OSTOSCOPE (ANALOG)
K951255
Introspect, Inc.
Ear, Nose, Throat · 41d
Cleared Apr 12, 1995
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
K950983
Introspect, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 06, 1995
WELCH ALLYN OTOSCOPE
K950787
Welch Allyn, Inc.
Ear, Nose, Throat · 44d
Cleared Mar 08, 1995
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 86d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Nov 08, 1994
HOME CARE EAR EXAMINATIO KIT
K944897
Home Care Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 11, 1994
VIDEO OTOSCOPE
K943731
Cuda Products Co.
Ear, Nose, Throat · 70d
Cleared Sep 23, 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031
Jedmed Instrument Co.
Ear, Nose, Throat · 37d
Cleared Aug 25, 1994
VIDEOTOSCOPE
K943916
Welch Allyn, Inc.
Ear, Nose, Throat · 14d
Cleared Jun 24, 1994
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
K942244
National Custom Ent., Inc.
Ear, Nose, Throat · 87d
Cleared Apr 26, 1994
AURAL-CAM, VIDEO EAR, VID RX
K941659
Gracefully Yours, Inc.
Ear, Nose, Throat · 21d
Cleared Dec 15, 1993
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
K932259
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 239d
Cleared Oct 08, 1993
STANDARD
K925752
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 329d
Cleared Oct 08, 1993
UNI III
K925753
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 329d

About Product Code ERA - Regulatory Context