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
2137–2160 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 25, 1997
NON-PRESCRIPTION SUNGLASSES
K965021 · HQY
Victory Eyewear Co., Ltd.
Ophthalmic · 71d
Cleared Feb 21, 1997
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K964751 · HQF
Ceram Optec, Inc.
Ophthalmic · 87d
Cleared Feb 20, 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · LPL
Sunsoft Corp.
Ophthalmic · 90d
Cleared Feb 18, 1997
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · KYF
Pharmacia Iovision, Inc.
Ophthalmic · 447d
Cleared Feb 03, 1997
RTA RETINAL THICKNESS ANALYZER
K964137 · HLI
Talia Technology , Ltd.
Ophthalmic · 111d
Cleared Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743 · HQE
Storz Instrument Co.
Ophthalmic · 69d
Cleared Jan 30, 1997
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
K963764 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 133d
Cleared Jan 30, 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
K964612 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 73d
Cleared Jan 29, 1997
EAGLE EYES
K964366 · HQY
Mech-Tronic Precision Mfg., Ltd.
Ophthalmic · 89d
Cleared Jan 29, 1997
SUNGLASSES
K964564 · HQY
Micron Metal & Plastic Manufactory Co.
Ophthalmic · 76d
Cleared Jan 29, 1997
SENNA
K964744 · HQY
Trans-America Enterprises Corp.
Ophthalmic · 64d
Cleared Jan 22, 1997
LC-250 INFRARED LIGHT COAGULATOR
K964380 · HQB
Nk-Optik America
Ophthalmic · 79d
Cleared Jan 10, 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · HQY
I C Optics, Ltd.
Ophthalmic · 63d
Cleared Jan 09, 1997
AMOILS EPITHELIAL SCRUBBER
K962989 · HOG
S. Percy Amoils
Ophthalmic · 161d
Cleared Jan 09, 1997
EYECHEK
K964290 · HLQ
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 73d
Cleared Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338 · HKM
Rudolf Riester GmbH & Co. KG
Ophthalmic · 70d
Cleared Dec 23, 1996
CORNEAL TOPOGRAPHER 200
K963762 · MMQ
Eclipse Ventures
Ophthalmic · 95d
Cleared Dec 20, 1996
VITLITE (TR7700)
K963417 · MPA
Escalon Trek Medical
Ophthalmic · 112d
Cleared Dec 20, 1996
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K963837 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 87d
Cleared Dec 20, 1996
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
K964222 · LYL
Paladin Medical, Inc.
Ophthalmic · 59d
Cleared Dec 20, 1996
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 59d
Cleared Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT...
K962185 · LPL
CooperVision, Inc.
Ophthalmic · 194d
Cleared Dec 17, 1996
EYE FIXATION SPECULUM
K964289 · HNC
Eyefix, Inc.
Ophthalmic · 50d
Cleared Dec 17, 1996
PLASTIC SUNGLASSES
K964316 · HQY
Medical Reports Exchange, Inc.
Ophthalmic · 49d