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
2905–2928 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 11, 1994
EYEGLASS FRAMES (PLASTIC)
K940411 · HQZ
Value Line Optical Services, Inc.
Ophthalmic · 74d
Cleared Apr 11, 1994
E.M.A.
K940612 · HQY
European Manufacturers Agency, Inc.
Ophthalmic · 56d
Cleared Apr 11, 1994
NONE-GENERIC
K940726 · HQY
Jay-Y Enterprises Co., Inc.
Ophthalmic · 52d
Cleared Apr 11, 1994
NON-PRESCRIPTION SUNGLASSES
K940806 · HQY
Top Fashion Optical & Sunglasses
Ophthalmic · 48d
Cleared Apr 11, 1994
WENZHOU IMPORT/EXPORT CORP. NON-PRESCRIPT SUNGLASSES
K940828 · HQY
Rainbow Merchandise, Inc.
Ophthalmic · 48d
Cleared Apr 11, 1994
REWINNER ENT CO. LTD. NON-PRESCRIPTION SUNGLASSES
K940830 · HQY
Rainbow Merchandise, Inc.
Ophthalmic · 48d
Cleared Apr 11, 1994
DAY SUN INDUSTRIAL CORP
K940944 · HQY
Day Sun Industrial Corp.
Ophthalmic · 42d
Cleared Apr 11, 1994
RIO EYEWEAR, PANAMA JACK ENVIRONMENT OPTICS, AND PARADISE RESORT EYEWEAR
K940956 · HQY
Rio Eyewear Group, Inc.
Ophthalmic · 41d
Cleared Apr 07, 1994
AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
K930320 · KYB
Allergan Medical Optics
Ophthalmic · 440d
Cleared Apr 06, 1994
PHACO NEEDLES 1000-R & 1000-O NEEDLES
K923630 · HQC
O.R. Specialties, Inc.
Ophthalmic · 624d
Cleared Apr 06, 1994
DAELIM CORP. EYE WEAR MODEL
K932612 · HQZ
Daelim Corp.
Ophthalmic · 313d
Cleared Apr 06, 1994
NON-PRESCRIPTION SUNGLASSES
K934461 · HQY
Good Bond Industrial Corp.
Ophthalmic · 208d
Cleared Apr 06, 1994
MTI PHOTOSCREENER
K934880 · MMF
Medical Technology and Innovations, Inc.
Ophthalmic · 176d
Cleared Apr 06, 1994
JIN CHANG SUNGLASSES
K935700 · HQY
Jin Chang Enterprise Co., Ltd.
Ophthalmic · 127d
Cleared Apr 06, 1994
SUNGLASSES
K935734 · HQY
Esparkle International Co., Ltd.
Ophthalmic · 126d
Cleared Apr 06, 1994
SPECTACLE FRAMES
K935845 · HQZ
New Star Corp.
Ophthalmic · 119d
Cleared Apr 06, 1994
SPECTACLE FRAMES AND SUNGLASSES
K935974 · HQY
Pan Oceanic Eyewear
Ophthalmic · 114d
Cleared Apr 06, 1994
SPECTACLE FRAME
K940326 · HQZ
D'Tochi, Inc.
Ophthalmic · 72d
Cleared Apr 06, 1994
TALKING RAP SHADES
K940420 · HQY
Hilco Corp.
Ophthalmic · 68d
Cleared Apr 06, 1994
SPECTACLE FRAMES
K940560 · HQZ
Optical Xpressions, Ltd.
Ophthalmic · 58d
Cleared Apr 06, 1994
E.M.A.
K940614 · HQZ
European Manufacturers Agency, Inc.
Ophthalmic · 51d
Cleared Apr 06, 1994
SUNGLASSES (NON-PRESCRIPTION)
K940778 · HQY
Hwa Meei Optical Co., Ltd.
Ophthalmic · 43d
Cleared Apr 01, 1994
SUNGLASSES
K935099 · HQY
Taiwan Tong AI Co., Ltd.
Ophthalmic · 161d
Cleared Apr 01, 1994
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
K935302 · HKS
Ocular Instruments, Inc.
Ophthalmic · 150d