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
2953–2976 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 22, 1994
AORP4000 REUSABLE PAK
K931358 · HQC
American Optical Corp.
Ophthalmic · 342d
Cleared Feb 22, 1994
SUNGLASSES
K931497 · HQY
Wain Lin Trading Corp.
Ophthalmic · 323d
Cleared Feb 22, 1994
SUNGLASSES
K931512 · HQY
Alpina U.S.A. Eyewear, Inc.
Ophthalmic · 333d
Cleared Feb 22, 1994
ELECTROCAUTERY SYSTEM MODEL 1980
K933079 · HQP
Pmt Corp.
Ophthalmic · 244d
Cleared Feb 22, 1994
LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE
K933633 · HJG
Gracefully Yours, Inc.
Ophthalmic · 210d
Cleared Feb 22, 1994
SUNGLASSES
K933819 · HQY
California Bazar
Ophthalmic · 202d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K934466 · HQZ
Airess, Inc.
Ophthalmic · 165d
Cleared Feb 22, 1994
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · HKI
Canon USA, Inc.
Ophthalmic · 147d
Cleared Feb 22, 1994
SUNGLASSES (NON-PRESCRIPTION)
K935114 · HQY
Promising Enterprise CO , Ltd.
Ophthalmic · 120d
Cleared Feb 22, 1994
NON-PRESCRIPTION SUNGLASSES
K935764 · HQY
Airess, Inc.
Ophthalmic · 165d
Cleared Feb 22, 1994
SPLASHMASTER PRESCRIPTION EYEWEAR
K935903 · HQY
Cabot Safety Corp.
Ophthalmic · 74d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K935968 · HQZ
Sae Biang Optical Co.
Ophthalmic · 71d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K935969 · HQY
Tae Kyung Optical Co., Inc.
Ophthalmic · 71d
Cleared Feb 22, 1994
R&D BATTERIES # 5615, 5234, 5097
K935988 · HLI
R & D Batteries, Inc.
Ophthalmic · 70d
Cleared Feb 22, 1994
OPTICAL FRAMES
K936004 · HQZ
Europa Continental, Inc.
Ophthalmic · 69d
Cleared Feb 22, 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018 · HLJ
R & D Batteries, Inc.
Ophthalmic · 68d
Cleared Feb 22, 1994
SUNGLASSES
K936033 · HQY
Tung Fang Mei Shieh Co., Ltd.
Ophthalmic · 67d
Cleared Feb 22, 1994
R & D BATTERIES
K936104 · HLJ
R & D Batteries, Inc.
Ophthalmic · 62d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K936146 · HQY
Franel Optical
Ophthalmic · 57d
Cleared Feb 22, 1994
ELITE COLLECTION
K936149 · HQZ
Omega Group, Inc.
Ophthalmic · 57d
Cleared Feb 22, 1994
EYEGLASS FRAMES
K936217 · HQZ
Ocean Optical Co., Inc.
Ophthalmic · 56d
Cleared Feb 22, 1994
SEE MONSTERS SUNGLASSES
K936218 · HQY
Doppler, Inc.
Ophthalmic · 57d
Cleared Feb 22, 1994
EYEGLASS FRAME
K940113 · HQZ
Wan Wing Optical Co.
Ophthalmic · 43d
Cleared Feb 22, 1994
PRESTIGE FRAMES
K940201 · HQZ
Eye Think Eyewear
Ophthalmic · 40d