Panels › Ear, Nose, Throat › Product code ERA · Class 1

Otoscope

Regulation 874.4770

0510(k)s in 12 months (56 all time)

0recalls in 12 months (1 all time)

0recalls that name a 510(k)

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Top companies in ERA

Company	510(k)s	Recalls
Rudolf Riester GmbH & Co. KG	9	0
Welch Allyn, Inc.	9	0
Jedmed Instrument Co.	4	0
Pedia Pals, Inc.	3	0
Artiberia	2	0
Conphar, Inc.	2	0
Introspect, Inc.	2	0
Oticon Corp.	2	0
Baxter Healthcare Corporation	0	1
Blue Focus	1	0

Decided	510(k)	Device and applicant	Code
May 17, 2013	K123821	AIO HD OTOSCOPE Blue Focus	ERA
Jan 25, 2013	K121326	LANTOS 3D EAR SCANNER Lantos Technologies	ERA
Oct 27, 2011	K110326	OSRAM ITOS Osram Sylvania, Inc.	ERA
Feb 2, 1996	K945264	OPTUS OTOSCOPES Optus, Inc.	ERA
Nov 14, 1995	K955043	WELCH ALLYN BI-OTOSCOPE Welch Allyn, Inc.	ERA
Jul 10, 1995	K952578	WELCH ALLY OTOSCOPE Welch Allyn, Inc.	ERA
May 12, 1995	K950913	PERFECT, ENT SET, PRAKTIKANT, DE LUXE Rudolf Riester GmbH & Co. KG, DE	ERA
May 3, 1995	K950788	OTOSCOPE A-34 Neitz Instruments Company, Ltd., JP	ERA
Apr 17, 1995	K951050	SPECULUM, ENT (S3) Pedia Pals, Inc.	ERA
Apr 17, 1995	K951049	SPECULUM, ENT (S3) Pedia Pals, Inc.	ERA
Apr 13, 1995	K951255	IMEDGE VIDEO OSTOSCOPE (ANALOG) Introspect, Inc.	ERA
Apr 12, 1995	K950983	IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE Introspect, Inc.	ERA
Apr 6, 1995	K950787	WELCH ALLYN OTOSCOPE Welch Allyn, Inc.	ERA
Mar 8, 1995	K946043	H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG Rudolf Riester GmbH & Co. KG, DE	ERA
Nov 18, 1994	K943721	OTOVIEW TELESCOPIC OTOSCOPES Smith & Nephew, Inc.	ERA
Nov 8, 1994	K944897	HOME CARE EAR EXAMINATIO KIT Home Care Instruments, Inc.	ERA
Oct 11, 1994	K943731	VIDEO OTOSCOPE Cuda Products Co.	ERA
Sep 23, 1994	K944031	VIDEO SCOPE SYSTEM (OTOSCOPE) Jedmed Instrument Co.	ERA
Aug 25, 1994	K943916	VIDEOTOSCOPE Welch Allyn, Inc.	ERA
Jun 24, 1994	K942244	REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE National Custom Ent., Inc.	ERA
Apr 26, 1994	K941659	AURAL-CAM, VIDEO EAR, VID RX Gracefully Yours, Inc.	ERA
Dec 15, 1993	K932259	CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE Clarus Medical Systems, Inc.	ERA
Oct 8, 1993	K932506	RI-SCOPE (S) Rudolf Riester GmbH & Co. KG, DE	ERA
Oct 8, 1993	K932505	RI-STAR Rudolf Riester GmbH & Co. KG, DE	ERA
Oct 8, 1993	K932503	RI-MINI Rudolf Riester GmbH & Co. KG, DE	ERA
Oct 8, 1993	K925753	UNI III Rudolf Riester GmbH & Co. KG, DE	ERA
Oct 8, 1993	K925752	STANDARD Rudolf Riester GmbH & Co. KG, DE	ERA
Aug 3, 1993	K925758	OTOSCOPE Rudolf Riester GmbH & Co. KG, DE	ERA
Jul 26, 1993	K925759	UNI I Rudolf Riester GmbH & Co. KG, DE	ERA
Nov 9, 1992	K923830	XOMED-TREACE ALPHASCOPE Xomed-Treace, Inc.	ERA
Nov 6, 1992	K924025	OTO-BRITE HANDLE Jedmed Instrument Co.	ERA
Oct 21, 1992	K923304	FAMILY EAR SCOPE MODEL 29001S Ear Care of So. Ca., Inc.	ERA
Sep 4, 1992	K922752	STARKEY LABORATORIES OTOSCOPE Starkey Laboratories, Inc.	ERA
Apr 23, 1992	K920322	OPTIEAR Nankivell Industries, Inc.	ERA
Jan 24, 1992	K915537	EARBEAR OTOSCOPE Earbear Co.	ERA
Oct 17, 1991	K911650	PEDIA PALS Pedia Pals, Inc.	ERA
Apr 30, 1991	K904659	DR. DEDO'S FAMILY EAR EXAMINATION KIT Panex Corp.	ERA
Jan 22, 1991	K904802	VIDEO OTOSCOPE Jedmed Instrument Co.	ERA
Aug 14, 1990	K902205	OTOSCOPE Truphatek, Ltd., IL	ERA
Jan 26, 1990	K896274	TYMPANOSCOPE Jedmed Instrument Co.	ERA
Aug 8, 1986	K862661	D.L. SCOPE(R) OTOSCOPE North American Medical Products, Inc.	ERA
Aug 1, 1986	K862624	I81 CITE Oticon Corp.	ERA
Aug 1, 1986	K862621	I22 INITIALES Oticon Corp.	ERA
Aug 29, 1985	K851745	1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B Artiberia	ERA
May 29, 1985	K851746	1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. Artiberia	ERA
Jul 13, 1984	K840593	DISPOSA-SPEC Plasti-Products, Inc.	ERA
Aug 12, 1983	K831614	INSPETOSCOPE Terayco Intl., Ltd.	ERA
Jun 30, 1983	K831709	AUDIOSCOPE #23000 W/71123 CHARGING STAND Welch Allyn, Inc.	ERA
Jan 19, 1982	K813305	CONPHAR OTOSCOPE Conphar, Inc.	ERA
Jan 19, 1982	K813299	CONPHAR OTOSCOPE/OPTHALMASCOPE Conphar, Inc.	ERA

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