FDA.reportPublic FDA data

Otoscope, direct

Definition
A portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.
GUDID devices
193
Last updated
2021-02-05 20:48:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04045396010215Otoscope head vacuum 2.7 V, pin contactRudolf Riester GmbH104202021-01-28
04045396010581ri-mini® F.O. otoscope head HL 2.5 V,Rudolf Riester GmbH105022021-01-28
04045396010796ri-scope® OP-otoscope head (veterinary) XL 3.5 VRudolf Riester GmbH105422021-01-28
04045396129962ri-scope® OP-otoscope head (human)Rudolf Riester GmbH10561-3012021-01-28
04045396130135uni® I otoscope XL 3.5 V, plug-in-styleRudolf Riester GmbH2012-2022021-01-28
04045396130180uni® I otoscope XL 2.5 V, C-handle,Rudolf Riester GmbH2014-2012021-01-28
04045396140059ri-scope® L F.O. otoscope L3 XL 2.5 V, C-handleRudolf Riester GmbH37012021-01-28
04045396140073ri-scope® L F.O. otoscope L2 LED 2.5 V, C-handleRudolf Riester GmbH37032021-01-28
04045396140080ri-scope® L F.O. otoscope L3 LED 2.5 V, C-handleRudolf Riester GmbH37042021-01-28
04045396140127ri-scope® L F.O. otoscope L2 LED 2.5 V, AA-handleRudolf Riester GmbH37082021-01-28
04045396141223ri-scope® L2 F.O. otoscope head XL 2.5 VRudolf Riester GmbH105642021-01-28
04045396141230ri-scope® F.O. otoscope head L2LED 3.5 VRudolf Riester GmbH105652021-01-28
04045396141254ri-scope® F.O. otoscope head L3 LED 3.5 VRudolf Riester GmbH105672021-01-28
04045396147034ri-scope® L1 otoscope head XL 3.5 V,Rudolf Riester GmbH10563-3012021-01-28
04045396147058ri-scope® L2 otoscope head LED 3.5 V,Rudolf Riester GmbH10565-3012021-01-28
04045396147072ri-scope® F.O. otoscope head L3 LED 3.5 V,Rudolf Riester GmbH10567-3012021-01-28
04045396148697ri-scope® L F.O. otoscope L2 LED 3.5 V, C-handle,Rudolf Riester GmbH3703-5502021-01-28
04045396148703ri-scope® L otoscope L3 LED 3.5 V, C-handleRudolf Riester GmbH3704-5502021-01-28
04045396153394ri-scope® F.O. otoscope head L2 XL 3.5 VRudolf Riester GmbH105802021-01-28
04045396153578ri-scope® F.O.otoscope head L2 XL 3.5 VRudolf Riester GmbH10580-3012021-01-28
04045396153585ri-scope® F.O. otoscopehead L3 XL 3.5 VRudolf Riester GmbH10581-3012021-01-28
04045396176881e-scope® otoscope, direct illumination, XL 2.5 V,Rudolf Riester GmbH2100-2012021-01-28
04045396176904e-scope® otoscope, direct illumination, XL 2.5 V,Rudolf Riester GmbH2101-2012021-01-28
04045396176911e-scope® F.O. otoscope XL 2.5V, white,Rudolf Riester GmbH2110-2022021-01-28
04045396176928e-scope® F.O. otoscope LED 3.7 V, white,Rudolf Riester GmbH2110-2032021-01-28
04045396176935e-scope® F.O. otoscope XL 2.5 V, black,Rudolf Riester GmbH2111-2022021-01-28
04045396176942e-scope® F.O. otoscope LED 3.7 V, black,Rudolf Riester GmbH2111-2032021-01-28
04045396181267ri-scope® L F.O. otoscope L3 XL 2.5 V, C-handle foRudolf Riester GmbH3701.0022021-01-28
04045396181328ri-scope® L F.O. otoscope L3 LED 3.5 V, C-handleRudolf Riester GmbH3704.0022021-01-28
04045396181403ri-scope® L F.O. otoscope L2 XL 2.5 V, C-handle foRudolf Riester GmbH3716.0022021-01-28
04045396209251ri-scope® F.O. otoscope head L2 LED 2.5 VRudolf Riester GmbH105822021-01-28
04045396209268ri-scope® F.O. otoscope head L3 LED 2.5 VRudolf Riester GmbH105832021-01-28
04045396209718EliteVue head only, LED, 2.5VRudolf Riester GmbH105102021-01-28
04045396209732EliteVue head only, XL, 2.5VRudolf Riester GmbH105112021-01-28
04045396209756EliteVue head only, LED, 3.5VRudolf Riester GmbH105122021-01-28
04045396209787EliteVue head only, XL, 3.5V,Rudolf Riester GmbH10513-3012021-01-28
04045396209800EliteVue otoscope set, XL, 2.5V, with C-handleRudolf Riester GmbH2200-2022021-01-28
04045396209817EliteVue otoscope set, LED, 3.5V, with C-handleRudolf Riester GmbH2200-2032021-01-28
04045396209824EliteVue otoscope set, LED, 2.5V, with C-handleRudolf Riester GmbH2200-2042021-01-28
04045396213395EliteVue head only, LED, 3.5V, with anti-theftRudolf Riester GmbH10512-3012021-01-28
04045396002739uni® I otoscope vacuum 2.7 V, C-handleRudolf Riester GmbH20102021-01-05
07290016672411Tyto OtoscopeTYTO CARE LTDTyto Otoscope, Plastic, BLK, US2020-10-10
M368122712LABTRONGF HEALTH PRODUCTS, INC.1227-12020-09-15
20025715697554EZY DOSE KIDSAPOTHECARY PRODUCTS, LLC697552020-09-09
M6333203500JEDMEDJEDMED INSTRUMENT COMPANY32-03502020-09-01
M6333203550JEDMEDJEDMED INSTRUMENT COMPANY32-03552020-09-01
M6333203710JEDMEDJEDMED INSTRUMENT COMPANY32-03712020-09-01
M6333203720JEDMEDJEDMED INSTRUMENT COMPANY32-03722020-09-01
M6333203730JEDMEDJEDMED INSTRUMENT COMPANY32-03732020-09-01
M6333974500JEDMEDJEDMED INSTRUMENT COMPANY39-74502020-09-01
M6333974510JEDMEDJEDMED INSTRUMENT COMPANY39-74512020-09-01
M6333974550JEDMEDJEDMED INSTRUMENT COMPANY39-74552020-09-01
M6333975150JEDMEDJEDMED INSTRUMENT COMPANY39-75152020-09-01
M6333981250JEDMEDJEDMED INSTRUMENT COMPANY39-81252020-09-01
M6333981540JEDMEDJEDMED INSTRUMENT COMPANY39-81542020-09-01
M6333981600JEDMEDJEDMED INSTRUMENT COMPANY39-81602020-09-01
M6333981700JEDMEDJEDMED INSTRUMENT COMPANY39-81702020-09-01
M6333981750JEDMEDJEDMED INSTRUMENT COMPANY39-81752020-09-01
M6333982400JEDMEDJEDMED INSTRUMENT COMPANY39-82402020-09-01
M6333982420JEDMEDJEDMED INSTRUMENT COMPANY39-82422020-09-01
M6333988000JEDMEDJEDMED INSTRUMENT COMPANY39-88002020-09-01
M63339X81530JEDMEDJEDMED INSTRUMENT COMPANY39X81532020-09-01
M63339X81540JEDMEDJEDMED INSTRUMENT COMPANY39X81542020-09-01
M63339X81600JEDMEDJEDMED INSTRUMENT COMPANY39X81602020-09-01
00732094326390Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-08-25
00732094326406Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-08-25
M6330361230JEDMEDJEDMED INSTRUMENT COMPANY03-61232020-08-03
M6330361300JEDMEDJEDMED INSTRUMENT COMPANY03-61302020-08-03
M6330361310JEDMEDJEDMED INSTRUMENT COMPANY03-61312020-08-03
M6330361320JEDMEDJEDMED INSTRUMENT COMPANY03-61322020-08-03
M6330361350JEDMEDJEDMED INSTRUMENT COMPANY03-61352020-08-03
M6330361360JEDMEDJEDMED INSTRUMENT COMPANY03-61362020-08-03
M6330361370JEDMEDJEDMED INSTRUMENT COMPANY03-61372020-08-03
M6330361390JEDMEDJEDMED INSTRUMENT COMPANY03-61392020-08-03
10050428387440CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATED715533-69755CV12020-07-29
00732094107654Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00732094107692Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00732094144048Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00850009819000WiscMedWISC MED, LLCWispr247012020-03-27
B809M300000003000Video Otoscopeorlvision GmbHOX22020-03-06