FDA.reportPublic FDA data

Ear speculum, single-use

Definition
A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.
GUDID devices
174
Last updated
2026-06-05 06:05:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, PediatricDynarex Corporation71162021-05-21
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mmDynarex Corporation71172021-05-21
00061678471172Disposable Ear Specula TipsDynarex Corporation71172021-05-21
00634782040338ADC®AMERICAN DIAGNOSTIC CORP5211-12016-09-21
00634782040345ADC®AMERICAN DIAGNOSTIC CORP5211-22016-09-21
00634782040352ADC®AMERICAN DIAGNOSTIC CORP5211-32016-09-21
00634782054458ADCAMERICAN DIAGNOSTIC CORP51822018-07-13
00634782054465ADCAMERICAN DIAGNOSTIC CORP51852018-07-13
00634782603045ADCAMERICAN DIAGNOSTIC CORP542022026-03-31
00634782603052ADCAMERICAN DIAGNOSTIC CORP542032026-03-31
00634782603069ADCAMERICAN DIAGNOSTIC CORP542042026-03-31
00634782603076ADCAMERICAN DIAGNOSTIC CORP542052026-03-31
00821925033283GYRUS ACMIGyrus ACMI, LLC1306982018-09-04
00821925033290GYRUS ACMIGyrus ACMI, LLC1306992018-09-04
00821925033306GYRUS ACMIGyrus ACMI, LLC1307002018-09-04
00821925033313GYRUS ACMIGyrus ACMI, LLC1307022018-09-04
00842209135141NARNORTH AMERICAN RESCUE, LLC20-00172025-05-23
00842209135158NARNORTH AMERICAN RESCUE, LLC20-00182025-05-23
04053755113941DISPOSABLE TIPS ALLSPEC 4 mmHeine Optotechnik GmbH & Co. KG10 boxes2022-12-21
04053755114009DISPOSABLE TIPS ALLSPEC 2,5 mmHeine Optotechnik GmbH & Co. KG10 boxes2023-01-11
04053755114061SOFT DISPOSABLE TIPSHeine Optotechnik GmbH & Co. KG40 x 3 mm2023-01-11
04053755114078SOFT DISPOSABLE TIPSHeine Optotechnik GmbH & Co. KG40 x 5 mm2023-01-11
04053755114153DISPOSABLE TIPS ALLSPEC 4 mmHeine Optotechnik GmbH & Co. KG10 boxes2023-01-11
04053755114160DISPOSABLE TIPS ALLSPEC 2,5 mmHeine Optotechnik GmbH & Co. KG10 boxes2023-01-11
04053755114412DISPOSABLE SPECULA UNISPECHeine Optotechnik GmbH & Co. KG1000 x 4 mm2023-01-11
04053755114436DISPOSABLE SPECULA UNISPECHeine Optotechnik GmbH & Co. KG1000 x 2,5 mm2023-01-11
04053755131327TIP ADAPTORHeine Optotechnik GmbH & Co. KGFOR BETA 200 VET2022-12-21
04053755192472DISPOSABLE TIPS ALLSPEC 4 mmHeine Optotechnik GmbH & Co. KG250 pcs.2023-01-11
04053755192489DISPOSABLE TIPS ALLSPEC 2,5 mmHeine Optotechnik GmbH & Co. KG250 pcs.2023-01-11
04250676730008MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbH50010012025-10-07
04250676730015MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbH50010022025-10-07
04250676730022MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbH50010032025-10-07
04250676730039MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbH50010042025-10-07
04250676730046MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbH50010052025-10-07
05060180255664EXMOOREXMOOR PLASTICS LIMITEDAS12018-09-17
05060180255671EXMOOREXMOOR PLASTICS LIMITEDAS22018-09-17
05060180255688EXMOOREXMOOR PLASTICS LIMITEDAS32018-09-17
05060180255695EXMOOREXMOOR PLASTICS LIMITEDAS3A2018-09-17
05060180255701EXMOOREXMOOR PLASTICS LIMITEDAS3B2018-09-17
05060180255718EXMOOREXMOOR PLASTICS LIMITEDAS42018-09-17
05060180255725EXMOOREXMOOR PLASTICS LIMITEDAS4A2018-09-17
05060180255732EXMOOREXMOOR PLASTICS LIMITEDAS52018-09-17
05060180255749EXMOOREXMOOR PLASTICS LIMITEDAS62018-09-17
05060180255756EXMOOREXMOOR PLASTICS LIMITEDAS72018-09-17
05060180255763EXMOOREXMOOR PLASTICS LIMITEDAS7A2018-09-17
05060180255770EXMOOREXMOOR PLASTICS LIMITEDAS7B2018-09-17
05060180255787EXMOOREXMOOR PLASTICS LIMITEDAS82018-09-17
05060180255794EXMOOREXMOOR PLASTICS LIMITEDAS8A2018-09-17
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09512024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09522024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09532024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09542024-07-04
10304040029197Henry ScheinHENRY SCHEIN, INC.11255272018-09-24
10304040029203Henry ScheinHENRY SCHEIN, INC.11255282018-12-21
10653160294450CenturionCENTURION MEDICAL PRODUCTS CORPORATIONI685052022-01-01
10850013784070Large OtoSight Speculum Tip QTY 20Photonicare, Inc.Large2022-04-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.MDSK103212023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.MDSK103312023-01-21
20612479194971McKessonMCKESSON MEDICAL-SURGICAL INC.16-1562020-07-10
20612479194995McKessonMCKESSON MEDICAL-SURGICAL INC.16-1572020-07-10
20612479195015McKessonMCKESSON MEDICAL-SURGICAL INC.16-1582020-07-10
27290018446120N9 speculumNONAGON LTDN/A2021-09-13
H65811255271Henry ScheinHENRY SCHEIN, INC.11255272020-06-16
H65811255281Henry ScheinHENRY SCHEIN, INC.11255282020-06-16
00732094055245Welch Allyn, Inc.WELCH ALLYN, INC.9010012026-03-06
10842209135148NARNORTH AMERICAN RESCUE, LLC20-00172025-05-23
10842209135155NARNORTH AMERICAN RESCUE, LLC20-00182025-05-23
08904461007139OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09512024-07-04
08904461007146OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09522024-07-04
08904461007153OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09532024-07-04
08904461007160OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEI09542024-07-04
00842209131631NARNORTH AMERICAN RESCUE, LLCZZ-16752024-06-12
00842209131624NARNORTH AMERICAN RESCUE, LLCZZ-16742024-06-10
04030155000613Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KG01.71112.0012023-08-30
04030155000637Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KG01.71122.0012023-08-30
04030155000651Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybagKirchner & Wilhelm GmbH + Co KG01.71212.0012023-08-30
04030155000668Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KG01.71212.0022023-08-30
04030155000682Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybagKirchner & Wilhelm GmbH + Co KG01.71222.0012023-08-30
04030155000699Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KG01.71222.0022023-08-30
M633S3814580JEDMEDJEDMED INSTRUMENT COMPANYS3814582023-04-26