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
2977–3000 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 22, 1994
SPECTACLE FRAMES
K940202 · HQZ
Sam Chung Optical Co., Ltd.
Ophthalmic · 40d
Cleared Feb 17, 1994
AUTOREF LENSMETER RL-10
K925304 · HKO
Canon USA, Inc.
Ophthalmic · 484d
Cleared Feb 17, 1994
KIRWAN IRRIGATION/ASPIRATION HANDPIECE
K930113 · HMX
Kirwan Surgical Products, Inc.
Ophthalmic · 402d
Cleared Feb 17, 1994
VISUAL HEALTHSHIELDS
K935446 · HQY
Yorktowne Optical Co., Inc.
Ophthalmic · 97d
Cleared Feb 16, 1994
MODIFIED SITE TXR SYSTEMS
K925828 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 457d
Cleared Feb 16, 1994
OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS
K930566 · HQZ
E.B. Brown Opticians
Ophthalmic · 378d
Cleared Feb 16, 1994
SUNGLASSES
K930659 · HQY
Kai Tai Optical Mfg. Co. , Ltd.
Ophthalmic · 372d
Cleared Feb 16, 1994
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH...
K934320 · HQR
Mentor O & O, Inc.
Ophthalmic · 166d
Cleared Feb 16, 1994
I/V POLE
K935226 · KYG
Optical Micro Systems, Inc.
Ophthalmic · 107d
Cleared Feb 16, 1994
SPECTACLE FRAMES
K935605 · HQZ
Sovereign Eyewear, Inc.
Ophthalmic · 89d
Cleared Feb 16, 1994
SUNGLASS FRAME
K935678 · HQY
Australian Optical Co., Inc.
Ophthalmic · 82d
Cleared Feb 16, 1994
OPTICAL FRAMES AND/OR SUNGLASSES
K935729 · HQZ
Ivo Eyewear, Inc.
Ophthalmic · 77d
Cleared Feb 16, 1994
MULTIPLE -SPECTACLE FRAMES/SUNGLASSES
K935798 · HQZ
Tae Kyung Optical Co., Inc.
Ophthalmic · 76d
Cleared Feb 16, 1994
SPECTACLE FRAME
K935918 · HQZ
Kenmark Optical Co., Inc.
Ophthalmic · 69d
Cleared Feb 16, 1994
SUNGLASSES
K935919 · HQG
Ja-Ru, Inc.
Ophthalmic · 70d
Cleared Feb 16, 1994
OPTICAL FRAME COLLECTION NO. 2
K935954 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 65d
Cleared Feb 09, 1994
SUNGLASSES
K934277 · HQY
Rainbow Optics, Inc.
Ophthalmic · 162d
Cleared Feb 07, 1994
INTERTIP INFUSION SET
K934204 · HQE
Oasis Medical, Inc.
Ophthalmic · 161d
Cleared Jan 25, 1994
GLASSES MOLASSES
K930174 · HQZ
Arthur F. Kozakowski, Jr.
Ophthalmic · 377d
Cleared Jan 25, 1994
TALIA LASER SLIT
K930518 · HJO
Talia Technology , Ltd.
Ophthalmic · 358d
Cleared Jan 25, 1994
AOD4000 DISPOSABLE PAK
K931357 · HQC
American Optical Corp.
Ophthalmic · 314d
Cleared Jan 25, 1994
APEX OPTICAL IND. CO., EYE WEA MODELS
K932821 · HQZ
Apex Optical Ind. Co.
Ophthalmic · 230d
Cleared Jan 25, 1994
SPECTACLE FRAMES AND SUNGLASSES
K933189 · HQY
Eastern Breeze Intl. Co.
Ophthalmic · 209d
Cleared Jan 25, 1994
SUNGLASSES
K933223 · HQY
Rally Accessories, Inc.
Ophthalmic · 208d