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
2185–2208 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Aug 26, 1996
LIGHT COMMANDER
K960767 · FCT
Scieran Technologies, Inc.
Ophthalmic · 182d
Cleared Aug 26, 1996
HORIZON/WESTHIN 55-G
K962121 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 87d
Cleared Aug 26, 1996
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
K962279 · HQY
Jane Fui Optical Co., Ltd.
Ophthalmic · 74d
Cleared Aug 26, 1996
RAVEN EYE, INC.- EYE WEAR
K962940 · HQY
Raven Eye, Inc.
Ophthalmic · 28d
Cleared Aug 26, 1996
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
K963083 · HQY
Piazza Optical Corp.
Ophthalmic · 18d
Cleared Aug 26, 1996
RAVEN EYE- EYE WEAR (SUNGLASSES)
K963284 · HQY
Raven Eye, Inc.
Ophthalmic · 28d
Cleared Aug 23, 1996
BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
K961103 · LPL
Benz Research and Development Corp.
Ophthalmic · 156d
Cleared Aug 23, 1996
STORZ D4600 AIR EXCHANGE LINE PACK
K962131 · HQC
Storz Instrument Co.
Ophthalmic · 81d
Cleared Aug 23, 1996
SUNQUEST INTERNATIONAL
K963059 · HQY
Sunquest Intl., Inc.
Ophthalmic · 21d