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
1777–1800 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 18, 1999
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
K992692 · LPL
Benz Research and Development Corp.
Ophthalmic · 68d
Cleared Oct 07, 1999
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
K992028 · LPN
Allergan, Inc.
Ophthalmic · 113d
Cleared Oct 04, 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
K992466 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 73d
Cleared Oct 01, 1999
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · LYL
Purilens, Inc.
Ophthalmic · 113d
Cleared Sep 24, 1999
MICROKERATOME, MODEL MK-2000
K990900 · HNO
Nidek, Inc.
Ophthalmic · 190d
Cleared Sep 24, 1999
VISINE FOR CONTACTS
K991620 · LPN
Pfizer, Inc.
Ophthalmic · 136d
Cleared Sep 24, 1999
MILLENIUM MICROKERATOME, MODEL IMD-001
K992687 · HMY
Industrial & Medical Design, Inc.
Ophthalmic · 45d
Cleared Sep 16, 1999
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
K984573 · LPN
Alcon Laboratories
Ophthalmic · 267d
Cleared Sep 14, 1999
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT...
K991125 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Aug 27, 1999
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
K991995 · MZD
Softchrome, Inc.
Ophthalmic · 74d
Cleared Aug 26, 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY...
K992589 · LPL
Opti-Centre Laboratories
Ophthalmic · 24d
Cleared Aug 18, 1999
DAILIES (NELFILCON A) ONE-DAY
K992446 · MVN
Ciba Vision Johns Creek Mfg.
Ophthalmic · 27d
Cleared Aug 18, 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT...
K992500 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 23d
Cleared Aug 16, 1999
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
K992339 · LPL
Colorsoft Laboratories Corp.
Ophthalmic · 34d
Cleared Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · MXK
Nidek, Inc.
Ophthalmic · 113d
Cleared Jul 16, 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · LPN
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Jul 13, 1999
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872 · LXP
Ophthalmic Consultants, Inc.
Ophthalmic · 119d
Cleared Jul 13, 1999
AHMED GLAUCOMA VALVE IMPLANT
K991072 · KYF
New World Medical, Inc.
Ophthalmic · 104d
Cleared Jul 08, 1999
FCI CRAWFORD PROBE INTUBATION SETS
K991238 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 87d
Cleared Jul 07, 1999
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES...
K984090 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 233d
Cleared Jul 07, 1999
OCUSYSTEM ART ADVANTAGE, MODEL 995
K991852 · HQC
Surgical Design Corp.
Ophthalmic · 36d
Cleared Jul 07, 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
K992054 · LPL
Adventures IN Color Technology, Ltd.
Ophthalmic · 20d
Cleared Jun 29, 1999
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX...
K991780 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d
Cleared Jun 29, 1999
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
K991781 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d