Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Otoscope

FDA product code ERA · 56 cleared devices

Class 1 Ear, Nose, Throat

Regulation: 21 CFR 874.4770
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-04-29 – 2013-05-17

ERA 2013-05-17

AIO HD OTOSCOPE

Applicant Blue Focus

K number K123821

View details →

ERA 2013-01-25

LANTOS 3D EAR SCANNER

Applicant Lantos Technologies

K number K121326

View details →

ERA 2011-10-27

OSRAM ITOS

Applicant Osram Sylvania, Inc.

K number K110326

View details →

ERA 1996-02-02

OPTUS OTOSCOPES

Applicant Optus, Inc.

K number K945264

View details →

ERA 1995-11-14

WELCH ALLYN BI-OTOSCOPE

Applicant Welch Allyn, Inc.

K number K955043

View details →

ERA 1995-07-10

WELCH ALLY OTOSCOPE

Applicant Welch Allyn, Inc.

K number K952578

View details →

ERA 1995-05-12

PERFECT, ENT SET, PRAKTIKANT, DE LUXE

Applicant Rudolf Riester GmbH & Co. KG

K number K950913

View details →

ERA 1995-05-03

OTOSCOPE A-34

Applicant Neitz Instruments Company, Ltd.

K number K950788

View details →

ERA 1995-04-17

SPECULUM, ENT (S3)

Applicant Pedia Pals, Inc.

K number K951050

View details →

ERA 1995-04-17

SPECULUM, ENT (S3)

Applicant Pedia Pals, Inc.

K number K951049

View details →

ERA 1995-04-13

IMEDGE VIDEO OSTOSCOPE (ANALOG)

Applicant Introspect, Inc.

K number K951255

View details →

ERA 1995-04-12

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE

Applicant Introspect, Inc.

K number K950983

View details →

ERA 1995-04-06

WELCH ALLYN OTOSCOPE

Applicant Welch Allyn, Inc.

K number K950787

View details →

ERA 1995-03-08

H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG

Applicant Rudolf Riester GmbH & Co. KG

K number K946043

View details →

ERA 1994-11-18

OTOVIEW TELESCOPIC OTOSCOPES

Applicant Smith & Nephew, Inc.

K number K943721

View details →

ERA 1994-11-08

HOME CARE EAR EXAMINATIO KIT

Applicant Home Care Instruments, Inc.

K number K944897

View details →

ERA 1994-10-11

VIDEO OTOSCOPE

Applicant Cuda Products Co.

K number K943731

View details →

ERA 1994-09-23

VIDEO SCOPE SYSTEM (OTOSCOPE)

Applicant Jedmed Instrument Co.

K number K944031

View details →

ERA 1994-08-25

VIDEOTOSCOPE

Applicant Welch Allyn, Inc.

K number K943916

View details →

ERA 1994-06-24

REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE

Applicant National Custom Ent., Inc.

K number K942244

View details →

ERA 1994-04-26

AURAL-CAM, VIDEO EAR, VID RX

Applicant Gracefully Yours, Inc.

K number K941659

View details →

ERA 1993-12-15

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE

Applicant Clarus Medical Systems, Inc.

K number K932259

View details →

ERA 1993-10-08

RI-SCOPE (S)

Applicant Rudolf Riester GmbH & Co. KG

K number K932506

View details →

ERA 1993-10-08

RI-STAR

Applicant Rudolf Riester GmbH & Co. KG

K number K932505

View details →

ERA 1993-10-08

RI-MINI

Applicant Rudolf Riester GmbH & Co. KG

K number K932503

View details →

ERA 1993-10-08

UNI III

Applicant Rudolf Riester GmbH & Co. KG

K number K925753

View details →

ERA 1993-10-08

STANDARD

Applicant Rudolf Riester GmbH & Co. KG

K number K925752

View details →

ERA 1993-08-03

OTOSCOPE

Applicant Rudolf Riester GmbH & Co. KG

K number K925758

View details →

ERA 1993-07-26

UNI I

Applicant Rudolf Riester GmbH & Co. KG

K number K925759

View details →

ERA 1992-11-09

XOMED-TREACE ALPHASCOPE

Applicant Xomed-Treace, Inc.

K number K923830

View details →

ERA 1992-11-06

OTO-BRITE HANDLE

Applicant Jedmed Instrument Co.

K number K924025

View details →

ERA 1992-10-21

FAMILY EAR SCOPE MODEL 29001S

Applicant Ear Care of So. Ca., Inc.

K number K923304

View details →

ERA 1992-09-04

STARKEY LABORATORIES OTOSCOPE

Applicant Starkey Laboratories, Inc.

K number K922752

View details →

ERA 1992-04-23

OPTIEAR

Applicant Nankivell Industries, Inc.

K number K920322

View details →

ERA 1992-01-24

EARBEAR OTOSCOPE

Applicant Earbear Co.

K number K915537

View details →

ERA 1991-10-17

PEDIA PALS

Applicant Pedia Pals, Inc.

K number K911650

View details →

ERA 1991-04-30

DR. DEDO'S FAMILY EAR EXAMINATION KIT

Applicant Panex Corp.

K number K904659

View details →

ERA 1991-01-22

VIDEO OTOSCOPE

Applicant Jedmed Instrument Co.

K number K904802

View details →

ERA 1990-08-14

OTOSCOPE

Applicant Truphatek, Ltd.

K number K902205

View details →

ERA 1990-01-26

TYMPANOSCOPE

Applicant Jedmed Instrument Co.

K number K896274

View details →

ERA 1986-08-08

D.L. SCOPE(R) OTOSCOPE

Applicant North American Medical Products, Inc.

K number K862661

View details →

ERA 1986-08-01

I81 CITE

Applicant Oticon Corp.

K number K862624

View details →

ERA 1986-08-01

I22 INITIALES

Applicant Oticon Corp.

K number K862621

View details →

ERA 1985-08-29

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B

Applicant Artiberia

K number K851745

View details →

ERA 1985-05-29

1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.

Applicant Artiberia

K number K851746

View details →

ERA 1984-07-13

DISPOSA-SPEC

Applicant Plasti-Products, Inc.

K number K840593

View details →

ERA 1983-08-12

INSPETOSCOPE

Applicant Terayco Intl., Ltd.

K number K831614

View details →

ERA 1983-06-30

AUDIOSCOPE #23000 W/71123 CHARGING STAND

Applicant Welch Allyn, Inc.

K number K831709

View details →

ERA 1982-01-19

CONPHAR OTOSCOPE

Applicant Conphar, Inc.

K number K813305

View details →

ERA 1982-01-19

CONPHAR OTOSCOPE/OPTHALMASCOPE

Applicant Conphar, Inc.

K number K813299

View details →

ERA 1981-11-06

P.P.P. TREATMENT CABINET

Applicant Precision Professional Products

K number K813003

View details →

ERA 1980-03-10

EARSCOPE

Applicant Nash & Assoc.

K number K800365

View details →

ERA 1979-01-26

ILLIMINATOR, MODEL 265 NASAL

Applicant Welch Allyn, Inc.

K number K782142

View details →

ERA 1978-06-28

OTOSCOPE, DIAG. MODELS 20100 & 20200

Applicant Welch Allyn, Inc.

K number K781029

View details →

ERA 1977-04-29

WALL CHARGER, MODEL #79111

Applicant Welch Allyn, Inc.

K number K770770

View details →

ERA 1977-04-29

OTOSCOPE/ILLUMINATOR, MODEL #21100

Applicant Welch Allyn, Inc.

K number K770769

View details →

↑