FDA.reportPublic FDA data

Surgical eye pressure shield

Definition
A non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient). It is designed as a rigid external eye shield (e.g., goggle like) intended to adhere to the face. This is a single-use device.
GUDID devices
97
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810071636486CuraplexBOUND TREE MEDICAL, LLCAEG1002022-12-30
00841668111123Eye ShieldKATENA PRODUCTS, INC.K9-60002020-09-14
00841668111130Eye ShieldKATENA PRODUCTS, INC.K9-60102020-09-14
00841668111147Eye ShieldKATENA PRODUCTS, INC.K9-60152020-09-14
00841668111154Eye ShieldKATENA PRODUCTS, INC.K9-60302020-09-14
00841668111161Eye ShieldKATENA PRODUCTS, INC.K9-60402020-09-14
00841668111178Eye ShieldKATENA PRODUCTS, INC.K9-60502020-09-14
00841668111185Eye ShieldKATENA PRODUCTS, INC.K9-61002020-09-14
00878799008084SURGISTARSURGISTAR, INC.5010402016-08-02
00878799008091SURGISTARSURGISTAR, INC.5010412016-08-02
00878799008107SURGISTARSURGISTAR, INC.5010432016-08-02
00878799008114SURGISTARSURGISTAR, INC.5010442016-08-02
10612479210124McKessonMCKESSON MEDICAL-SURGICAL INC.159-212020-07-20
10612479210148McKessonMCKESSON MEDICAL-SURGICAL INC.159-222020-07-20
10612479210162McKessonMCKESSON MEDICAL-SURGICAL INC.159-232020-07-20
10889483047910SunMed LLCSUNMED, LLC9-0210-21I2024-11-11
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.BL-0400 2026-04-10
16931918188713AllesetGRI Medical & Electronic Technology Co., Ltd.25-04002023-08-07
13700773727503OCULAR SHIELD FCI S A S FCI 20 22S6.23012025-03-24
13700773724755OCULAR SHIELD FCI S A S FCI 20 22S6.23012021-05-30
20889483047917SunMed LLCSUNMED, LLC9-0210-21I2024-11-11
00840306836152Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0482024-10-30
00840306836169Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0472024-10-30
00840306836176Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0492024-10-30
00840306836183Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.043-0472024-10-30
00840306836190Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.044-0102024-10-30
00840306836206Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.044-1002024-10-30
00840306836213Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.050-0002024-10-30
00840306836220Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0142024-10-30
00840306836237Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0152024-10-30
00840306836244Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0182024-10-30
00840306836251Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0202024-10-30
00840306836268Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0392024-10-30
00840306836275Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0402024-10-30
00840306836282Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0422024-10-30
00840306836299Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0432024-10-30
00840306836305Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.042-0442024-10-30
G586NS184810Novo SurgicalNOVO SURGICAL, INC.NS1-84812024-10-14
00194613028268MSI Precision Specialty InstrumentsMed Saver, Inc.23-201BH2024-08-15
00194613028299MSI Precision Specialty InstrumentsMed Saver, Inc.23-202BH2024-08-15
00194613028312MSI Precision Specialty InstrumentsMed Saver, Inc.23-204BH2024-08-15
00194613043537MSI Precision Specialty InstrumentsMed Saver, Inc.1770-FX502024-08-15
00194613059439MSI Precision Specialty InstrumentsMed Saver, Inc.17-202-502024-08-15
00194613090760MSI Precision Specialty InstrumentsMed Saver, Inc.17-502-502024-08-15
00194613091804MSI Precision Specialty InstrumentsMed Saver, Inc.17-502-5002024-08-15
10889483033272SunMedSUNMED, LLC9-0210-202024-03-12
10889483035498SunMedSUNMED, LLC9-0210-002024-03-12
10889483043905SunMedSUNMED, LLC9-0210-212024-03-12
10889483047903SunMedSUNMED, LLC9-0210-00I2024-03-12
06931918188716AllesetGRI Medical & Electronic Technology Co., Ltd.25-04002023-08-07
00854428006003Surgical Eye ShieldJardon Eye Prosthetics, Inc.Pediatric Orange2023-06-26
00854428006010Surgical Eye ShieldJardon Eye Prosthetics, Inc.Pediatric Green2023-06-26
00854428006027Surgical Eye ShieldJardon Eye Prosthetics, Inc.Pediatric White2023-06-26
00854428006034Surgical Eye ShieldJardon Eye Prosthetics, Inc.Pediatric Clear2023-06-26
00854428006041Surgical Eye ShieldJardon Eye Prosthetics, Inc.Small Orange2023-06-26
00854428006058Surgical Eye ShieldJardon Eye Prosthetics, Inc.Small Green2023-06-26
00854428006065Surgical Eye ShieldJardon Eye Prosthetics, Inc.Small Clear2023-06-26
00854428006072Surgical Eye ShieldJardon Eye Prosthetics, Inc.Small Black2023-06-26
00854428006089Surgical Eye ShieldJardon Eye Prosthetics, Inc.Small White2023-06-26
00854428006096Surgical Eye ShieldJardon Eye Prosthetics, Inc.Medium Orange2023-06-26
00854428006102Surgical Eye ShieldJardon Eye Prosthetics, Inc.Medium Green2023-06-26
00854428006119Surgical Eye ShieldJardon Eye Prosthetics, Inc.Medium Clear2023-06-26
00854428006126Surgical Eye ShieldJardon Eye Prosthetics, Inc.Medium White2023-06-26
00854428006133Surgical Eye ShieldJardon Eye Prosthetics, Inc.Medium Black2023-06-26
00854428006140Surgical Eye ShieldJardon Eye Prosthetics, Inc.Large Orange2023-06-26
00854428006157Surgical Eye ShieldJardon Eye Prosthetics, Inc.Large Green2023-06-26
00854428006164Surgical Eye ShieldJardon Eye Prosthetics, Inc.Large Clear2023-06-26
00854428006188Surgical Eye ShieldJardon Eye Prosthetics, Inc.Large White2023-06-26
00854428006348Silicone ConformerJardon Eye Prosthetics, Inc.Small2023-06-26
00854428006447Surgical Eye ShieldJardon Eye Prosthetics, Inc.Pediatric Black2023-06-26
00854428006874Surgical Eye ShieldJardon Eye Prosthetics, Inc.Large Black2023-06-26
M689HHCES01040Combat Eye ShieldSafeguard US Operating, LLC042022-09-08
00190660218416Ambler SurgicalAMBLER SURGICAL CORP.Scleral eye shield2021-01-04
00190660218423Ambler SurgicalAMBLER SURGICAL CORP.Scleral eye shield2021-01-04
00857048006217H&H Combat Eye SheildH&H MEDICAL CORPORATION12020-12-31
50885632109964MediChoiceOWENS & MINOR DISTRIBUTION, INC.EP15002020-09-30
50885632109988MediChoiceOWENS & MINOR DISTRIBUTION, INC.EP35002020-09-30
00841668100998Eye ShieldKATENA PRODUCTS, INC.K1-84802020-09-14
00841668101001Eye ShieldKATENA PRODUCTS, INC.K1-84812020-09-14
00841668101018Eye ShieldKATENA PRODUCTS, INC.K1-84822020-09-14