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
1417–1440 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 06, 2003
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR...
K030842 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 81d
Cleared Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · HKI
Canon USA, Inc.
Ophthalmic · 10d
Cleared May 30, 2003
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON...
K030593 · LPL
X-Cel Contacts, A Walman Co.
Ophthalmic · 94d
Cleared May 22, 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · HQC
Phacor Inc., A Santen Company
Ophthalmic · 17d
Cleared May 14, 2003
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT,...
K030748 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 65d
Cleared May 09, 2003
OPAQUE HERRICK LACRIMAL PLUG
K030300 · LZU
Lacrimedics, Inc.
Ophthalmic · 100d
Cleared May 06, 2003
RTA MODEL D RETINAL THICKNESS ANALYZER
K031312 · HLI
Talia Technology , Ltd.
Ophthalmic · 12d
Cleared May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 130d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 80d
Cleared Apr 25, 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K030353 · OKS
Eagle Vision, Inc.
Ophthalmic · 81d
Cleared Apr 24, 2003
APPLANATION TONOMETER
K023676 · HKX
Optilasa, S.L.
Ophthalmic · 174d
Cleared Apr 17, 2003
VELOCITY ADVANTAGE
K023939 · HQE
Visioncare Devices, Inc.
Ophthalmic · 142d
Cleared Apr 17, 2003
OPHTEC ENCLAVATION NEEDLE
K030471 · HNQ
Ophtec, USA
Ophthalmic · 64d
Cleared Apr 04, 2003
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K030092 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 84d
Cleared Apr 04, 2003
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K030548 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 43d
Cleared Apr 02, 2003
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH...
K030167 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 76d
Cleared Apr 01, 2003
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT
K030027 · LPL
Gelflex Laboratories
Ophthalmic · 88d
Cleared Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
K030350 · KYF
Optonol, Ltd.
Ophthalmic · 38d
Cleared Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · MRC
Ciba Vision Corporation
Ophthalmic · 136d
Cleared Feb 26, 2003
SCLERAL PLUGS, 19 AND 20 GAUGE
K022186 · LXP
Microvision, Inc.
Ophthalmic · 236d
Cleared Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023987 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023989 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · HJK
Fci Ophthalmics, Inc.
Ophthalmic · 51d
Cleared Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
K023643 · MTZ
Macropore Biosurgery, Inc.
Ophthalmic · 114d