FDA.reportPublic FDA data

Eyelid speculum, single-use

Definition
A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.
GUDID devices
183
Last updated
2026-07-17 21:59:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810189451704Surgical DesignSurgical Design, Inc.DS-152026-06-10
00749756371346DeRoyalDEROYAL INDUSTRIES, INC.SP100-012021-07-28
00749756371353DeRoyalDEROYAL INDUSTRIES, INC.SP100-022021-08-23
00749756666091DeRoyalDEROYAL INDUSTRIES, INC.32-18102021-06-30
00810799039118Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10012020-09-23
00810799039132Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10022020-09-23
00810799039156Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10052020-09-23
00810799039170Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10102020-09-23
00810799039194Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10152020-09-23
00810799039217Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10162020-09-23
00810799039231Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10262020-09-23
00810799039255Stephens InstrumentsKRISHNA IMPORTS INCSSD1 10702020-09-23
00840516127231Anodyne SurgicalPsi/Eye-Ko, Inc.84002023-08-02
00840516127248Anodyne SurgicalPsi/Eye-Ko, Inc.84012023-08-02
00840516127255Anodyne SurgicalPsi/Eye-Ko, Inc.84042023-08-02
00840516127262Anodyne SurgicalPsi/Eye-Ko, Inc.8404P2023-08-02
00840516127279Anodyne SurgicalPsi/Eye-Ko, Inc.84052023-08-02
00840516127767Anodyne SurgicalPsi/Eye-Ko, Inc.84002023-08-02
00840516127774Anodyne SurgicalPsi/Eye-Ko, Inc.84012023-08-02
00840516127781Anodyne SurgicalPsi/Eye-Ko, Inc.84042023-08-02
00840516127798Anodyne SurgicalPsi/Eye-Ko, Inc.8404P2023-08-02
00840516127804Anodyne SurgicalPsi/Eye-Ko, Inc.84052023-08-02
00840516135144Walcott Rx ProductsPsi/Eye-Ko, Inc.Rx1102023-08-18
00840516135151Walcott Rx ProductsPsi/Eye-Ko, Inc.Rx1122023-08-18
00840516135168Walcott Rx ProductsPsi/Eye-Ko, Inc.Rx1142023-08-18
00840516135175Walcott Rx ProductsPsi/Eye-Ko, Inc.Rx1172023-08-18
00840516138473Anodyne SurgicalPsi/Eye-Ko, Inc.84022024-02-09
00840516138503Anodyne SurgicalPsi/Eye-Ko, Inc.84022024-02-09
00841668115541Ophthlamic SpeculumKATENA PRODUCTS, INC.K20-10172020-09-14
00841668142967PROBST LASIK SPECULUM 10/BOXKATENA PRODUCTS, INC.AS-10082022-12-13
03700483601110ONEMORIA SAONE-KRATZ WIRE SPECULUM - OPEN BL.2023-12-28
03700483601431ONEMORIA SAONE-ADJUSTABLE PLAST.SPECULUM2023-12-28
03700483611911ONEMORIA SAOne S-adj speculum with swivels x52023-12-29
03700483612710ONEMORIA SAONE S-Wire speculum with tabs X52023-12-29
03700483620173ONEMORIA SAOne-pediatric wire speculum x102023-12-28
03700483620432ONEMORIA SAOne S-adj speculum with swivels x102023-12-29
03700483621873ONEMORIA SAONE S-Wire speculum with tabs X102023-12-29
03700483625574ONEMORIA SASPECULUM SOLID BLADE/ TABS2023-12-29
04058935005245BARRAQUER LID SPECULUM 24BBausch & Lomb GmbHSUH012023-09-12
04058935005269SPECULUM ADJUSTABLE 6BBausch & Lomb GmbHSUH042023-09-12
05056785300557Speculum LeibingerBLINK MEDICAL LIMITED31-30022025-09-18
05056785301448Paediatric Speculum Angled TemporalBLINK MEDICAL LIMITED31-31022025-01-07
05056785301462Barraquer Neonatal Speculum with Finger tipsBLINK MEDICAL LIMITED31-31032025-01-07
05056785302117Solid Blade Plastic Barraquer Speculum, StdBLINK MEDICAL LIMITED31-30072025-06-02
05056785302971Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITED31-30052026-02-04
05056785302995Plastic Solid Bladed Mechanical SpeculumBLINK MEDICAL LIMITED31-30062026-02-04
05060480407510Speculum Barraquer StraightBLINK MEDICAL LIMITED30-20042023-10-23
05060480407527Speculum BurattoBLINK MEDICAL LIMITED30-30012023-10-23
05060480407572Speculum Kratz-Barraquer Angled NasalBLINK MEDICAL LIMITED31-10052023-10-23
05060480407596Speculum Barraquer Angled NasalBLINK MEDICAL LIMITED31-20022023-10-23
05060480407633Speculum Cook EyeBLINK MEDICAL LIMITED31-30032024-03-18
05060480407640Speculum ClarkesBLINK MEDICAL LIMITED31-30042024-03-18
05060745555864Speculum Kratz-Barraquer Curved Angled TemporalBLINK MEDICAL LIMITED31-10092022-08-01
05060745558308Speculum Solid BladeBLINK MEDICAL LIMITED31-40022024-03-14
05404027412726Sterile, Single Use, Speculum Lieberman Fine, Open BladesHasa Optix6550352023-11-13
05404027412788Sterile, Single Use, Speculum Adjustable Full Rounded BladesHasa Optix6550412023-11-13
05404027427188Sterile, Single Use, Kratz Barraquer Wire Speculum, 13.5mm Open BladesHasa Optix5550012023-11-23
05404027427249Sterile, Single Use, Wire Speculum, 14mm Open Blades, L 45mmHasa Optix5550072024-07-22
05404027427393Sterile, Single Use, Lieberman Adjustable Speculum, V-Shaped Wire, L 65mmHasa Optix5550232024-07-22
05404027427447Sterile,Single Use,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mmHasa Optix5550282024-07-22
05404027427478Sterile, Single Use, Lindstrom-Chu Aspirating Speculum, L 65mmHasa Optix5550312024-07-22
05404027427584Sterile, Single Use, Speculum Adjustable Fine Full BladesHasa Optix6550382023-11-23
10649111441332SklarSKLAR CORPORATION820902019-05-13
10649111446207SklarSKLAR CORPORATION820952019-05-13
10649111446214SklarSKLAR CORPORATION821002019-05-13
10812594011853Neotech Ocular Exam KitNeotech Products LLCNeonatal2021-06-14
10812594012485Neonatal Ocular Exam Kit 2-packNeotech Products LLC108125940124852021-06-14
10812594012492Neotech Ocular Exam KitNeotech Products LLCStandard2021-06-14
10812594012508Ocular Exam DepressorNeotech Products LLC108125940125082021-06-14
10812594012515Ocular Exam Neonatal SpeculumNeotech Products LLC108125940125152021-06-14
10812594012522Ocular Exam Standard SpeculumNeotech Products LLC108125940125222021-06-14
10841668112424Ophthlamic SpeculumKATENA PRODUCTS, INC.K20-10102020-09-14
10841668115159Ophthlamic SpeculumKATENA PRODUCTS, INC.K20-10072020-09-14
35055186207404Malosa MedicalBeaver-Visitec International, Inc.MMSU1252S2022-02-19
35055186207428Malosa MedicalBeaver-Visitec International, Inc.MMSU1253S2022-02-19
35055186207800Malosa MedicalBeaver-Visitec International, Inc.MMSU1275S2022-02-19
35055186216765Malosa MedicalBeaver-Visitec International, Inc.MMSU1290S2022-02-19
35055186216956Malosa MedicalBeaver-Visitec International, Inc.MMSU1287S2022-02-19
35055186225835Malosa MedicalBeaver-Visitec International, Inc.MMSU1475S2022-02-19
05056785302988Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITED31-30052026-02-04