FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
3049–3072 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 02, 1993
SUNGLASSES
K931990 · HQY
American Eye Way, Inc.
Ophthalmic · 194d
Cleared Nov 02, 1993
PROMOTIONAL SUNGALSSES
K932416 · HQY
Associated Premium Corp.
Ophthalmic · 168d
Cleared Nov 02, 1993
EH-270 CORNEAL TOPOGRAPHER
K933556 · HLQ
Visioptic, Inc.
Ophthalmic · 104d
Cleared Nov 02, 1993
TRACTION PRODUCTIONS SPECTACLE FRAMES
K934249 · HQZ
Traction Productions, USA
Ophthalmic · 67d
Cleared Nov 02, 1993
ANIMAL NONPRESCRIPTION SUNGLASSES
K934304 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
AVIATOR NONPRESCRIPTION SUNGLASSES
K934305 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
BUTTERFLY NONPRESCRIPTION SUNGLASSES
K934307 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
CHILD NONPRESCRIPTION SUNGLASSES
K934308 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES
K934309 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Oct 20, 1993
MODISSA 90 S.R.L. SUNGLASSES
K930858 · HQY
Modissa 90 Srl
Ophthalmic · 244d
Cleared Oct 20, 1993
SIGMA-BRILLEN (OR) MULTIPLE
K930956 · HQZ
Sigma-Brillen
Ophthalmic · 239d
Cleared Oct 20, 1993
EYEGLASSES FRAMES
K933529 · HQZ
Vistula Assistance & Consulting Bureau
Ophthalmic · 92d
Cleared Oct 18, 1993
UNI II
K925756 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 339d
Cleared Oct 18, 1993
LD 400
K930937 · HPT
Vismed, Inc.
Ophthalmic · 237d
Cleared Oct 18, 1993
FASHION ITALIANA EYEWEAR
K933089 · HQY
Fashion Italiana, Inc.
Ophthalmic · 117d
Cleared Oct 18, 1993
MUGNIER JERIK SUNGLASSES
K933718 · HQY
Huntley Global Ent.
Ophthalmic · 80d
Cleared Oct 18, 1993
FRAME-SPECTACLE
K933765 · HQZ
Clearvision Optical Co., Inc.
Ophthalmic · 76d
Cleared Oct 18, 1993
OPTO LINE SRL
K933809 · HQZ
Optoline S.R.L.
Ophthalmic · 75d
Cleared Oct 18, 1993
FRAMES
K933865 · HQZ
Hillman'S, the Eyecare Co., Inc.
Ophthalmic · 70d
Cleared Oct 18, 1993
SPECTACLE FRAMES
K933891 · HQZ
Euro Frame Design, Inc.
Ophthalmic · 69d
Cleared Oct 18, 1993
ASICS SUNGLASSES
K933905 · HQY
Asics Tiger Corp.
Ophthalmic · 68d
Cleared Oct 18, 1993
ALDO'S OPTICAL FRAME COLLECTION
K933956 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 67d
Cleared Oct 18, 1993
SPECTACLE FRAMES
K933991 · HQZ
U.S. Optical
Ophthalmic · 62d
Cleared Oct 18, 1993
SPECTACLE SUNGLASSES (NON-PERSCRIPTION)
K934034 · HQY
H.M.O. Optical, Inc.
Ophthalmic · 61d