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
817–840 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · HKI
Topcon Corp.
Ophthalmic · 94d
Cleared Apr 30, 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 221d
Cleared Apr 23, 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K123973 · LPL
Pegavision Corporation
Ophthalmic · 118d
Cleared Apr 15, 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
K123888 · MSS
Aaren Scientific, Inc.
Ophthalmic · 118d
Cleared Apr 12, 2013
IOLMASTER 500
K122418 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared Apr 03, 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · LRX
The Lagado Corp.
Ophthalmic · 57d
Cleared Apr 02, 2013
EXCELSIOR
K130453 · NFJ
Eyekor, LLC
Ophthalmic · 39d
Cleared Mar 29, 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON...
K123484 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 136d
Cleared Mar 27, 2013
TBD
K123859 · OOE
Lensar, Inc.
Ophthalmic · 103d
Cleared Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS...
K122220 · LPL
Soflex Limited
Ophthalmic · 237d
Cleared Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 158d
Cleared Mar 14, 2013
NIDEK RS-3000
K121622 · OBO
Nidek Co., Ltd.
Ophthalmic · 286d
Cleared Mar 05, 2013
CALLISTO EYE
K123464 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 116d
Cleared Feb 26, 2013
HEINE OMEGA 500
K123316 · HLI
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 124d
Cleared Feb 22, 2013
OPTOS OCT/SLO MICROPERIMETER
K121043 · OBO
Optos Plc.
Ophthalmic · 323d
Cleared Feb 22, 2013
MYVISIONTRACK(TM)
K121738 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 254d
Cleared Feb 21, 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT...
K123994 · LPL
Ciba Vision Corporation
Ophthalmic · 57d
Cleared Feb 15, 2013
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS...
K122315 · LPL
Oculus Private Limited
Ophthalmic · 198d
Cleared Feb 08, 2013
VICTUS FEMTOSECOND LASER PLATFORM
K122386 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 186d
Cleared Feb 06, 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K123460 · HKI
Topcon Medical Systems, Inc.
Ophthalmic · 89d
Cleared Jan 31, 2013
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
K112880 · MYC
Freedom Meditech, Inc.
Ophthalmic · 489d
Cleared Jan 31, 2013
DURETTE OCULAR IMPLANT
K123764 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 55d
Cleared Jan 18, 2013
IVUE WITH NORMATIVE DATABASE
K121739 · HLI
Optovue, Inc.
Ophthalmic · 219d