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
2713–2736 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 04, 1994
SPECTACLE FRAME
K943085 · HQZ
Winntics Optical Industry Co. , Ltd.
Ophthalmic · 37d
Cleared Aug 04, 1994
ORVIS DRIVING GLASSES
K943161 · HQY
The Orvis Co., Inc.
Ophthalmic · 34d
Cleared Aug 04, 1994
CIBA VISION(R) CONTACT LENS CASE
K943183 · LRX
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Aug 04, 1994
EVERYTHING KIDS
K943328 · HQY
Jcc Co., Inc.
Ophthalmic · 23d
Cleared Aug 02, 1994
SUNGLASSES
K941540 · HQY
Tonview International Co., Ltd.
Ophthalmic · 125d
Cleared Aug 02, 1994
SUNGLASSES
K941929 · HQY
Top Champ, Inc.
Ophthalmic · 104d
Cleared Aug 02, 1994
ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS
K942951 · HQY
The Orvis Co., Inc.
Ophthalmic · 40d
Cleared Aug 02, 1994
SPECTACLE FRAME
K943083 · HQZ
Pimex Co., Ltd.
Ophthalmic · 35d
Cleared Aug 02, 1994
SPECTACLE FRAME
K943086 · HQZ
Radiant Spectacles Manufacturers
Ophthalmic · 35d
Cleared Aug 02, 1994
ORVIS POLARIZED BI-FOCALS
K943131 · HQY
The Orvis Co., Inc.
Ophthalmic · 34d
Cleared Aug 02, 1994
OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX
K943236 · HQZ
Optiline Imports and Trade, Inc.
Ophthalmic · 27d
Cleared Aug 02, 1994
SPECTACLE FRAMES
K943442 · HQZ
Sunny Union Industrial Co., Ltd.
Ophthalmic · 15d
Cleared Aug 02, 1994
SUNGLASSES
K943443 · HQY
Sunny Union Industrial Co., Ltd.
Ophthalmic · 15d
Cleared Jul 28, 1994
ESSTECH PS ASPHERIC
K942186 · LPL
Szabocsik and Assoc.
Ophthalmic · 85d
Cleared Jul 28, 1994
ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K942187 · LPL
Szabocsik and Assoc.
Ophthalmic · 85d
Cleared Jul 28, 1994
H55 HYDROPHILIC CONTACT LENS
K942214 · LPL
Martin S. Knopf Assoc., Inc.
Ophthalmic · 83d
Cleared Jul 28, 1994
HIGH PERFORMANCE TIPS
K943102 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 29d
Cleared Jul 27, 1994
OPTICAL FRAMES AND SUNGLASSES
K926564 · HQY
Solstar Produktions GmbH
Ophthalmic · 573d
Cleared Jul 27, 1994
MICRODRIVE
K934600 · HQE
Medical Instrument Development...
Ophthalmic · 306d
Cleared Jul 27, 1994
GLADIATOR
K942932 · HQY
Gladiator Sports
Ophthalmic · 35d
Cleared Jul 27, 1994
EASSUN HI-TECH OPTICS
K943202 · HQY
Ultimate Concepts, Inc.
Ophthalmic · 22d
Cleared Jul 27, 1994
MS-30 AUTOMATIC PERIMETER
K943234 · HPT
Marco Ophthalmic, Inc.
Ophthalmic · 21d
Cleared Jul 25, 1994
OPTICOM M600
K932258 · HPT
Clement Clarke, Inc.
Ophthalmic · 441d
Cleared Jul 25, 1994
MARS SUNGLASSES
K932484 · HQY
Mars Promotional Services, Inc.
Ophthalmic · 427d