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
3361–3384 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 15, 1991
COLLAGEN SHIELD FOR ACUTE CARE
K913148 · MOE
Vitaphore Corp.
Ophthalmic · 91d
Cleared Oct 15, 1991
NIDEK MODEL NT-1000
K913189 · HKX
Nidek, Inc.
Ophthalmic · 89d
Cleared Oct 15, 1991
DUCAL SIDE SHIELD SUNGLASS
K913745 · HQY
Ducal Trading Corp.
Ophthalmic · 62d
Cleared Oct 10, 1991
TURBOTRON 20/20
K902920 · LYL
Prestige Manufacturing Snd Bhd
Ophthalmic · 464d
Cleared Oct 09, 1991
CCI VIDEOKERATOSCOPE/COMPARATOR
K913022 · HLQ
Cci
Ophthalmic · 92d
Cleared Oct 09, 1991
GLAUCOMA-SCOPE
K913118 · HLI
Ophthalmic Imaging Systems
Ophthalmic · 86d
Cleared Oct 02, 1991
EYE BUBBLE
K912367 · HOY
Aaron Medical Industries
Ophthalmic · 126d
Cleared Oct 02, 1991
UNIDIRECTIONAL OCCLUDER
K913230 · HOY
Welch Allyn, Inc.
Ophthalmic · 72d
Cleared Oct 02, 1991
THE PAN.OPTX SPORTGLASS
K913388 · HQY
Panoptx, Inc.
Ophthalmic · 65d
Cleared Sep 27, 1991
HEIDELBERG RETINA TOMOGRAPH
K912891 · HLI
Heidelberg Engineering
Ophthalmic · 88d
Cleared Sep 25, 1991
DESERT SHIELD SUNGLASSES
K912863 · HQY
Command Marketing Corp.
Ophthalmic · 89d
Cleared Aug 30, 1991
ARTIFICIAL SCLERAL SHELL
K904961 · HQT
Midwest Eye Laboratories, Inc.
Ophthalmic · 298d
Cleared Aug 30, 1991
EYE ARTIFICIAL CUSTOM
K904962 · HQH
Midwest Eye Laboratories, Inc.
Ophthalmic · 298d
Cleared Aug 28, 1991
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
K912739 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 68d
Cleared Aug 28, 1991
FRAMES (EYE GLASSES)
K913046 · HQZ
Jiuh Chyi Ent. Co., Ltd.
Ophthalmic · 50d
Cleared Aug 22, 1991
VENETO COLLECTION
K912034 · HQZ
Atlantic Optical Co., Inc.
Ophthalmic · 106d
Cleared Aug 21, 1991
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
K910828 · MLP
Ocular Instruments, Inc.
Ophthalmic · 175d
Cleared Aug 21, 1991
STAR*SHADES(TM) SUNGLASSES
K912608 · HQY
Nalpac , Ltd.
Ophthalmic · 70d
Cleared Aug 12, 1991
PMT METAL LOCATOR, MODEL 3630-1
K911886 · HPM
Pmt Corp.
Ophthalmic · 105d
Cleared Aug 09, 1991
TBD KERATOSCOPE
K912130 · HLQ
Alcon Laboratories
Ophthalmic · 87d
Cleared Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K912253 · HQE
Ocular Instruments, Inc.
Ophthalmic · 78d
Cleared Aug 07, 1991
LANDERS NOTCHED VITRECTOMY LENS RING
K912268 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Aug 07, 1991
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
K912269 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Jul 26, 1991
PLASTIC OVERLAYS
K911374 · HKW
National Reading Service
Ophthalmic · 120d