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
2545–2568 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 18, 1995
STERISEAL OPHTHALMIC CANNULA
K943932 · HMX
Pharma-Plast, Ltd.
Ophthalmic · 159d
Cleared Jan 17, 1995
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K945172 · HQX
Visitec Co.
Ophthalmic · 88d
Cleared Jan 17, 1995
RI-SCOPE S OTOSCOPE
K945640 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 62d
Cleared Jan 17, 1995
SUNGLASSES
K945920 · HQY
Glendale Protective Technologies, Inc.
Ophthalmic · 43d
Cleared Jan 17, 1995
EYEWEAR/SPECTACLES
K945925 · HQY
Kovision Mfg., Ltd.
Ophthalmic · 43d
Cleared Jan 17, 1995
PROWAY
K946132 · HQY
Union Industrial Co., Ltd.
Ophthalmic · 32d
Cleared Jan 17, 1995
EYE COOLER
K946231 · HQY
Direct Import Marketing Co.
Ophthalmic · 26d
Cleared Jan 17, 1995
SUNGLASSES
K946256 · HQY
Chanel, Inc.
Ophthalmic · 25d
Cleared Jan 13, 1995
KOLBERG OPHTHALMIC CONFORMER
K945110 · HQN
Kolberg Ocular Products, Inc.
Ophthalmic · 87d
Cleared Jan 12, 1995
HEINE LAMBDA 100
K944156 · HOX
Heine USA , Ltd.
Ophthalmic · 139d
Cleared Jan 12, 1995
POWERR RANGERS SUNGLASSES
K945917 · HQY
Dollar Land Stores, Inc.
Ophthalmic · 38d
Cleared Jan 12, 1995
SUNGLASSES
K945988 · HQY
R.J. Standard Corp.
Ophthalmic · 35d
Cleared Jan 09, 1995
SUNGLASSES
K944568 · HQY
Great Field Industries Co., Ltd.
Ophthalmic · 112d
Cleared Jan 09, 1995
POWER RANGERS SUNGLASSES
K945823 · HQY
Avon Products, Inc.
Ophthalmic · 41d
Cleared Jan 05, 1995
PECTACLE FRAMES AND/OR SUNGLASSES
K945147 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 77d
Cleared Jan 05, 1995
VETTA LIGHTWEIGHT CYCLING EYEWEAR
K945683 · HQY
Shaw, Pittman, Potts & Trowbridge
Ophthalmic · 45d
Cleared Jan 05, 1995
SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES
K945735 · HQY
Shu Gie Industrial Co., Ltd.
Ophthalmic · 43d
Cleared Jan 05, 1995
SUNGLASSES
K945817 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
SUNGLASSES
K945818 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
SUNGLASSES
K945819 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
BUNNY SUNGLASSES
K945840 · HQY
Tony (U.S.A.), Inc.
Ophthalmic · 36d
Cleared Jan 03, 1995
SILICONE PUNCTAL PLUG
K945906 · LZU
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Dec 28, 1994
HORIZON 55 BI-CON
K945365 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 56d
Cleared Dec 22, 1994
ARCTIC PREMIER SERIES
K944700 · HOY
Sungold Eyewear, Inc.
Ophthalmic · 90d