Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
2185–2208 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 19, 1996
VARIOUS SUNGLASSES (NON-PRESCRIPTION)
K963890 · HQY
Italian Eyewear, Inc.
Ophthalmic · 54d
Cleared Nov 19, 1996
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
K963955 · HQY
Bert & Joe'S, Inc.
Ophthalmic · 48d
Cleared Nov 19, 1996
FLYWAY
K963968 · HQY
Look Style, S.R.L.
Ophthalmic · 47d
Cleared Nov 05, 1996
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
K960287 · HQC
Nidek, Inc.
Ophthalmic · 288d
Cleared Oct 28, 1996
RETINAL DETACHMENT IMPLANTS
K963219 · HQX
Fci Ophthalmics, Inc.
Ophthalmic · 73d
Cleared Oct 22, 1996
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
K963333 · HKI
Karl Storz Imaging, Inc.
Ophthalmic · 60d
Cleared Oct 18, 1996
C.O.L.D.A.
K963630 · HQY
C.O.L.D.A. S.N.C.
Ophthalmic · 37d
Cleared Oct 09, 1996
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · HQD
Menicon Co, Ltd.
Ophthalmic · 140d
Cleared Oct 02, 1996
PHACOSCOPE
K960811 · HQC
Saint John'S Plaza Medical Group
Ophthalmic · 218d
Cleared Oct 01, 1996
PRECISION UV (VASURFILCON A)
K961299 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 180d
Cleared Oct 01, 1996
FLEXLENS
K961943 · LPL
Flexlens, Inc.
Ophthalmic · 134d
Cleared Oct 01, 1996
FLEXLENS(METHAFILCON A)
K962000 · LPL
Flexlens, Inc.
Ophthalmic · 132d
Cleared Oct 01, 1996
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
K962804 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 75d
Cleared Oct 01, 1996
RURASOFT 2 FRESHLOOK COLORS
K962957 · LPL
Wesley Jessen Corp.
Ophthalmic · 63d
Cleared Sep 20, 1996
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE...
K960024 · HQC
Storz Instrument Co.
Ophthalmic · 262d
Cleared Sep 19, 1996
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
K962402 · HQC
Allergan, Inc.
Ophthalmic · 90d
Cleared Sep 18, 1996
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061 · HQE
Storz Instrument Co.
Ophthalmic · 258d
Cleared Sep 18, 1996
RYDER LACRIMAL INTUBATIONSET
K962151 · OKS
Ryder Intl. Corp.
Ophthalmic · 106d
Cleared Sep 05, 1996
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K962710 · LPL
Gelflex Laboratories
Ophthalmic · 87d
Cleared Sep 05, 1996
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
K962711 · LPL
Gelflex Laboratories
Ophthalmic · 87d
Cleared Aug 29, 1996
STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
K960003 · HQC
Storz Instrument Co.
Ophthalmic · 240d
Cleared Aug 29, 1996
D.O.R.C. MICRODIATHERMY SYSTEM
K962135 · HQO
Dutch Ophthalmic USA, Inc.
Ophthalmic · 87d
Cleared Aug 28, 1996
OCULIGHT GL
K960971 · HQF
Iriderm Div.
Ophthalmic · 170d
Cleared Aug 27, 1996
AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY...
K962934 · HQD
Airperm, Inc.
Ophthalmic · 29d