FDA.reportPublic FDA data

Otoscope, direct

Definition
An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
GUDID devices
243
Last updated
2026-09-04 23:10:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04260381960164LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KG12026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KG12026-08-26
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10O2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10O2026-07-17
00860003469828hearXHEARX GROUP (PTY) LTDhearScope2022-05-30
00025715697550EZY DOSE KIDSAPOTHECARY PRODUCTS, LLC697552020-09-09
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATED6354782026-02-13
00050428387443CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATED715533-69755CV12020-07-29
00311917035000WalgreensWALGREEN CO.7693792023-11-01
00697077003098Amico Diagnostic OtoscopeAmico Diagnostic IncorporatedDH-W35-FL-L2025-10-10
00697077003104Amico Diagnostic OtoscopeAmico Diagnostic IncorporatedDH-W35-FH-L2025-10-08
00697077003111Amico Diagnostic OtoscopeAmico Diagnostic IncorporatedDH-W35-OH2025-10-08
00697077003128Amico Diagnostic OtoscopeAmico Diagnostic IncorporatedDH-W35-OL2025-10-08
00697077003142Amico Diagnostic OtoscopeAmico Diagnostic IncorporatedDH-W35-FX-L 2025-10-08
00732094011951Welch Allyn, Inc.WELCH ALLYN, INC.9010012022-11-02
00732094107579Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00732094230468Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-04-26
00732094230475Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-11-03
00732094230536Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00732094230550Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00732094326369Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-08-25
00732094326376Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-08-25
00732094355550Welch Allyn, Inc.WELCH ALLYN, INC.9010012024-03-07
00732094355567Welch Allyn, Inc.WELCH ALLYN, INC.9010012024-03-07
00810055257812ROYAL TEKSurgical Design, Inc.RT-182-SV2026-05-17
00810055257829ROYAL TEKSurgical Design, Inc.RT-182-BK2026-05-17
00810055257836ROYAL TEKSurgical Design, Inc.RT-181-BL2026-05-17
00810055257843ROYAL TEKSurgical Design, Inc.RT-DS-10PK-5PK2026-05-17
04053755114405INSUFFLATION BULBHeine Optotechnik GmbH & Co. KG0002022-12-12
04053755114481TIP ADAPTORHeine Optotechnik GmbH & Co. KGFOR BETA 1002022-12-12
04053755114894BETA 200 OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V2022-12-12
04053755114979K 180 OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V2022-12-12
04053755114986K 180 OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V TL2022-12-12
04053755124121MINI3000 F.O.Heine Optotechnik GmbH & Co. KG2,5 V2022-12-12
04053755124275MINI3000 OTOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-12
04053755131518BETA 200 VET. OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V2022-12-21
04053755131549G100 Heine Optotechnik GmbH & Co. KG3,5 V2022-12-21
04053755158591MINI3000 F.O. LED OTOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-12
04053755179169BETA 400 OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V2022-12-12
04053755179176BETA 400 OTOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V TL2022-12-12
04053755182558BETA 400 LED OTOSCOPEHeine Optotechnik GmbH & Co. KG0002022-12-12
04053755182565BETA 200 LED OTOSCOPEHeine Optotechnik GmbH & Co. KG0002022-12-12
04053755188604G100 LEDHeine Optotechnik GmbH & Co. KG0002022-12-21
04053755202904BETA X OtoscopeHeine Optotechnik GmbH & Co. KG3x2025-07-18
04053755202911BETA X OtoscopeHeine Optotechnik GmbH & Co. KG4.2 x2025-07-18
04053755203574BETA X VET OTOSCOPEHeine Optotechnik GmbH & Co. KG0002026-03-31
04053755207541XV4 BETA X VET SPECULUMHeine Optotechnik GmbH & Co. KG4 MM2026-03-31
04053755207558XV6 BETA X VET SPECULUMHeine Optotechnik GmbH & Co. KG6 MM2026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER Heine Optotechnik GmbH & Co. KG0002026-03-31
06945095540977zumaxZumax Medical Co., LTDOT8D2026-05-18
06945095543756zumaxZumax Medical Co., LTDOT8G2026-05-18
06945095543800zumaxZumax Medical Co., LTDOT8G2026-05-21
06945095543909zumaxZumax Medical Co., LTDOT8V2026-05-21
06945095543978zumaxZumax Medical Co., LTDOT8D2026-05-21
06945095544111zumaxZumax Medical Co., LTDOT8D2026-05-21
06945095544142zumaxZumax Medical Co., LTDOT8C2026-05-21
06945095544173zumaxZumax Medical Co., LTDOT8D2026-05-21
06945095544180zumaxZumax Medical Co., LTDOT8K2026-05-21
06945095544326zumaxZumax Medical Co., LTDOT8D2026-05-21
06945095544388zumaxZumax Medical Co., LTDOT8C2026-05-21
06945095544494zumaxZumax Medical Co., LTDOT8C2026-05-21
06945095544586zumaxZumax Medical Co., LTDOT8D2026-05-21
06945095544913zumaxZumax Medical Co., LTDOT8K2026-05-21
06945095545149zumaxZumax Medical Co., LTDOT8C2026-05-21
06972545090126JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10A2026-05-18
06972545090225JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10J2026-05-18
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10A2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OT10J2026-05-18
KTS0025716K.T.SurgicoK.T.SURGICO20242024-07-24
M368122711LABTRONGF HEALTH PRODUCTS, INC.1227-12020-09-15
M6333974410JEDMEDJEDMED INSTRUMENT COMPANY39-74412022-12-19
40050428029495CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATED6354782026-02-13
00883873030608LIFEPAK 15 AC Power AdapterPHYSIO-CONTROL, INC.415772026-02-10