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
2761–2784 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 15, 1994
SEIKO EYEGLASS FRAME
K942513 · HQZ
Seiko Optical Products of America, Inc.
Ophthalmic · 50d
Cleared Jul 15, 1994
SURGI-WIPE
K942642 · HOZ
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 42d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K942783 · HQY
Sunpoint Import Co., Inc.
Ophthalmic · 31d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K925596 · HQY
European & Foreign Imports, Inc.
Ophthalmic · 614d
Cleared Jul 12, 1994
CHEN-HERSIN SUNGLASSES
K940488 · HQY
Chen Hersin Ent.
Ophthalmic · 158d
Cleared Jul 12, 1994
AUTO REFF-30
K940516 · HKO
Canon, Inc.
Ophthalmic · 158d
Cleared Jul 12, 1994
CHEN SHUENG ENTERPRISE CO.
K940625 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
CLEVER OPTICAL INDUSTRIES LTD
K940626 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
WENZHOU IMPORT AND EXPORT CORP
K940627 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
JIHN MEI OPTICAL CO.
K940628 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
YEOU NAN SUNGLASSES CO
K940629 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
SUNGLASSES
K940924 · HQY
Sunny Sunglasses
Ophthalmic · 134d
Cleared Jul 12, 1994
WESTERN TRADING CO
K941047 · HQY
Eva Optiks, Inc.
Ophthalmic · 127d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES
K941053 · HQY
Hsin Chen Intl. Co., Ltd.
Ophthalmic · 131d
Cleared Jul 12, 1994
EYECOTECH CORP
K941414 · HQZ
Eyecotech Corp.
Ophthalmic · 111d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K941441 · HQY
Sun-Set Enterprise Co. , Ltd.
Ophthalmic · 110d
Cleared Jul 12, 1994
SUNGLASSES
K941538 · HQY
Solar Sunglasses Corp.
Ophthalmic · 104d
Cleared Jul 12, 1994
SUNGLASSES/VARIOUS COLLECTIONS
K941555 · HQY
Atlantic Optical Co., Inc.
Ophthalmic · 103d
Cleared Jul 12, 1994
PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
K942348 · HQZ
Oliver Peoples, Inc.
Ophthalmic · 56d
Cleared Jul 12, 1994
FRAME, SPECTACLE
K942463 · HQZ
Erica Optical Co.
Ophthalmic · 49d
Cleared Jul 12, 1994
SUNGLASSES TOKYO BAY
K942500 · HQY
Tokyo Bay, Inc.
Ophthalmic · 49d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K942588 · HQY
Pro Axess
Ophthalmic · 41d
Cleared Jul 12, 1994
SCHOOL MASCOT EYEWEAR
K942652 · HQY
School Mascot Eyewear, Inc.
Ophthalmic · 39d
Cleared Jul 08, 1994
SUNGLASSES
K941910 · HQY
The Orvis Co., Inc.
Ophthalmic · 80d