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
4201–4224 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 04, 1986
SUPERLITE PENLIGHT
K861028
Keta Corp.
Ophthalmic · 17d
Cleared Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
K861063 · HLQ
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Mar 31, 1986
SIMMONS SHELL
K855105 · HQT
Mira, Inc.
Ophthalmic · 98d
Cleared Mar 31, 1986
OPTHALMIC SURGICAL INSTRUMENTS
K860744 · HMX
Tridak Division of Indicon, Inc.
Ophthalmic · 32d
Cleared Mar 31, 1986
SPECTACLES FRAME
K860954 · HQZ
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
SPECTACLES LENS
K860955 · HQG
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
RARE EARTH INTRA-OCULAR MAGNET
K860960 · HPN
Ameritek, Inc.
Ophthalmic · 18d
Cleared Mar 31, 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · KYG
Ameritek, Inc.
Ophthalmic · 13d
Cleared Mar 28, 1986
SAPPHIRE BLADE SURGICAL KNIFE
K860852 · HNN
Med-Tech Develoment Corp.
Ophthalmic · 21d
Cleared Mar 25, 1986
BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
K860648 · HRH
Precision Instruments, Inc.
Ophthalmic · 33d
Cleared Mar 21, 1986
MAZZOCCO/FRENCHIK FOLDER
K860148 · KYB
Staar Surgical Co.
Ophthalmic · 65d
Cleared Mar 21, 1986
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)
K860358 · HQF
Hgm, Inc.
Ophthalmic · 50d
Cleared Mar 11, 1986
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
K853808 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 11, 1986
DAILY HARD CONTACT LENS CLEANER
K853809 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 05, 1986
INTRAOCULAR FORCEPS & SCISSORS
K854869 · HNR
Mira, Inc.
Ophthalmic · 91d
Cleared Mar 05, 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · HNN
Storz Instrument Co.
Ophthalmic · 78d
Cleared Mar 05, 1986
SYSTEMS PLUS
K860014 · HQE
United Surgical Corp.
Ophthalmic · 61d
Cleared Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Feb 27, 1986
DIGILAB CAMBRIDGE PERIMETER
K860115 · HOO
Bio-Rad
Ophthalmic · 45d
Cleared Feb 19, 1986
UVASORB-400
K854442 · HPX
Optatint, Inc.
Ophthalmic · 106d
Cleared Feb 19, 1986
INTRAOCULAR ELECTROMAGNET
K854870 · HPO
Mira, Inc.
Ophthalmic · 77d
Cleared Feb 18, 1986
MONOPOLAR INJECTION NEEDLE ELECTRODE
K854793 · HLW
Oculinum, Inc.
Ophthalmic · 75d