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
3097–3120 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 01, 1993
MARCHON/MARCOLIN EYEGLASSES
K933733 · HQZ
Marchon Eyewear, Inc.
Ophthalmic · 60d
Cleared Sep 20, 1993
SUNGLASSES
K925428 · HQY
Dallas Handbag Co.
Ophthalmic · 328d
Cleared Sep 20, 1993
NON-PRESCRIPTION SUNGLASSES
K926096 · HQY
Lunettes Bondet
Ophthalmic · 292d
Cleared Sep 20, 1993
SPECTACLE FRAMES
K930435 · HOI
Venis DI A. Vendrame
Ophthalmic · 237d
Cleared Sep 20, 1993
SUNGLASSES
K931504 · HQY
The B & F System, Inc.
Ophthalmic · 179d
Cleared Sep 20, 1993
SPIRIT SHIELD
K931718 · HQY
Eaton Medical Corp.
Ophthalmic · 167d
Cleared Sep 20, 1993
ROLLENS POST-MYDRIATIC SUNGLASS
K932646 · HQY
Rollens Professional Products, Inc.
Ophthalmic · 110d
Cleared Sep 20, 1993
FRAMES, SPECTACLES
K932772 · HQZ
Optical Designs and Sourcing, Inc.
Ophthalmic · 104d
Cleared Sep 20, 1993
FRAMES, SPECTACLES
K932773 · HQZ
Diaco, Inc.
Ophthalmic · 104d
Cleared Sep 20, 1993
NON-PRESCRIPTION SUGLASSES
K932814 · HQY
Sun Style Intl. Corp.
Ophthalmic · 103d
Cleared Sep 20, 1993
SUNGLASSES
K932939 · HQY
Soft-Ray Optical Corp.
Ophthalmic · 96d
Cleared Sep 20, 1993
SUNGLASSES
K932940 · HQY
Sun and Young Sunglasses Co., Ltd.
Ophthalmic · 96d
Cleared Sep 20, 1993
SUNGLASSES
K932941 · HQY
Rayman Speco Co., Ltd.
Ophthalmic · 96d
Cleared Sep 20, 1993
SUNGLASSES
K933074 · HQZ
P.T. Sun and Young Indonesia Sunglasses
Ophthalmic · 89d
Cleared Sep 20, 1993
EYEGLASS FRAMES
K933254 · HQY
Sam Chung Optical Co., Ltd.
Ophthalmic · 80d
Cleared Sep 20, 1993
STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN
K933423 · HQZ
Thunder Industries, Inc.
Ophthalmic · 69d
Cleared Sep 20, 1993
STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN
K933424 · HQZ
Zyloware Corp.
Ophthalmic · 69d
Cleared Sep 20, 1993
MULTIPLE
K933616 · HQY
Greg and Greg, Inc.
Ophthalmic · 63d
Cleared Sep 20, 1993
MARCHON/MARCOLIN SUNGLASSES
K933734 · HQY
Marchon Eyewear, Inc.
Ophthalmic · 49d
Cleared Sep 20, 1993
SPECTACLE FRAME
K933874 · HQZ
Designer Frames
Ophthalmic · 45d
Cleared Sep 09, 1993
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · HJO
Carl Zeiss, Inc.
Ophthalmic · 304d
Cleared Sep 09, 1993
STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
K926512 · HQC
Storz
Ophthalmic · 253d
Cleared Sep 09, 1993
SPECTACLE FRAME
K932802 · HQZ
Insight Optical Mfg. Co. of Florida,...
Ophthalmic · 92d
Cleared Sep 09, 1993
NEW STAR, TAE HAN OPTICAL
K932999 · HQZ
J.B. Eyewear, Inc.
Ophthalmic · 83d