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
4105–4128 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 24, 1986
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · HQF
CooperVision, Inc.
Ophthalmic · 48d
Cleared Sep 24, 1986
-OM WEST 2000 GNATUS CHAIR
K863008 · HME
Sds Dental, Inc.
Ophthalmic · 47d
Cleared Sep 24, 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · HKX
Bio-Rad
Ophthalmic · 35d
Cleared Sep 24, 1986
KASEY EYE SHIELD
K863474 · HOY
Kasey Enterprises, Inc.
Ophthalmic · 15d
Cleared Sep 17, 1986
3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
K863129 · LYX
3M Company
Ophthalmic · 33d
Cleared Sep 08, 1986
US PLUS-PAK(R) SURGICAL SYSTEM
K863209 · HQC
Ipax, Inc.
Ophthalmic · 19d
Cleared Sep 03, 1986
SENSORY 6
K862338 · HPG
Brytech, Inc.
Ophthalmic · 75d
Cleared Sep 03, 1986
AQUALUX LENS CASE
K862811 · HPX
Safeway Products, Inc.
Ophthalmic · 41d
Cleared Sep 03, 1986
OPM SLIT LAMP MODEL P-1 & MODEL P-3
K863048 · HJO
Optek Medico Co., Ltd.
Ophthalmic · 22d
Cleared Sep 03, 1986
EVE COLLECTION (EYEGLASS FRAME)
K863125 · HQZ
Precision Lens Crafters
Ophthalmic · 19d
Cleared Sep 03, 1986
EYE BARRIER
K863182 · HQZ
O.R. Concepts, Inc.
Ophthalmic · 15d
Cleared Sep 03, 1986
COMPUTON(R)
K863200 · HKX
Optical Radiation Corp.
Ophthalmic · 15d
Cleared Aug 25, 1986
CORNEAL MODELING SYSTEM
K862379 · HJO
Computed Anatomy, Inc.
Ophthalmic · 62d
Cleared Aug 21, 1986
KEELER DUAL LIGHTSOURCE
K861746 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
KEELER FIBEROPTIC HEADLAMP
K861747 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
K862188 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 73d
Cleared Aug 21, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Aug 21, 1986
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692 · HKS
Ocular Instruments, Inc.
Ophthalmic · 37d
Cleared Aug 21, 1986
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713 · HKS
Ocular Instruments, Inc.
Ophthalmic · 36d
Cleared Aug 21, 1986
SOLARSHIELDS
K862719 · HQY
Dioptics
Ophthalmic · 35d
Cleared Aug 21, 1986
HOSKINS NYLON SUTURE LASER LENS
K862728 · HJK
Ocular Instruments, Inc.
Ophthalmic · 34d
Cleared Aug 21, 1986
ABRAHAM YAG LASER LENS
K862868 · HJK
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
PETRUS SINGLE MIRROR LASER LENS
K862869 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 16d