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
4489–4512 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 19, 1984
EPISCLERAL VENOUS PRESSURE
K843354 · HKX
Eyetech, LLC
Ophthalmic · 84d
Cleared Nov 08, 1984
EZ EYE DROP AID
K841896
Buckman Co., Inc.
Ophthalmic · 185d
Cleared Nov 08, 1984
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
K843966 · HQB
American Medical Optics
Ophthalmic · 28d
Cleared Nov 06, 1984
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
K843345
Mira, Inc.
Ophthalmic · 71d
Cleared Nov 06, 1984
ARGON LASER PHOTOCOAGULATOR SYS
K843965 · HQF
American Medical Optics
Ophthalmic · 26d
Cleared Nov 05, 1984
AMER. EDWARDS LAB FLEXISCOPE
K842410 · HRK
American Edwards Laboratories
Ophthalmic · 139d
Cleared Oct 05, 1984
CATAREX VITRECUTTER I/A DISPOS. CUT
K840063 · HQC
Calliope Corp.
Ophthalmic · 270d
Cleared Oct 05, 1984
CATAREX/ULTRASONICS KIT
K840181 · HQC
Calliope Corp.
Ophthalmic · 262d
Cleared Oct 05, 1984
CORNEAL LIGHT SHIELD
K840834 · HOY
Gabl, Inc.
Ophthalmic · 224d
Cleared Oct 05, 1984
AMER. SURGICAL CORP. EXTRA PLUS PAK
K841738 · HQE
American Surgical Co., Inc.
Ophthalmic · 161d
Cleared Oct 05, 1984
CANON AUTOREF R-10
K841861 · HKO
Canon USA, Inc.
Ophthalmic · 154d
Cleared Oct 05, 1984
MICROSCOPE MITTS SUPPORT TRAY COVER
K842859 · HJO
Chiron Vision Corp.
Ophthalmic · 74d
Cleared Oct 05, 1984
NIDEK DIGITAL KERATOMETER
K842892 · HQL
Nidek, Inc.
Ophthalmic · 74d
Cleared Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
K843021 · HKI
Canon USA, Inc.
Ophthalmic · 65d
Cleared Oct 05, 1984
VISION TESTER
K843042 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 64d
Cleared Oct 05, 1984
RING SUPPORTED TREPHINE FOR CORNEA TRANS
K843048 · HRH
Precision Instruments, Inc.
Ophthalmic · 63d
Cleared Oct 05, 1984
TRIA LENS SET
K843095 · HPC
Optek Medico Co., Ltd.
Ophthalmic · 59d
Cleared Oct 05, 1984
FRAME SPECTACLE
K843123 · HQZ
Vision Industries Corp.
Ophthalmic · 58d
Cleared Oct 05, 1984
VISITEC FLIERINGA-LEGRAND FIXATION RING
K843195 · HMH
Visitec Co.
Ophthalmic · 52d
Cleared Oct 05, 1984
VISITEC EYE SPECULUM
K843196 · HNC
Visitec Co.
Ophthalmic · 52d
Cleared Oct 05, 1984
CILCO DIAMOND KNIFE
K843447 · HNN
Cilco, Inc.
Ophthalmic · 30d
Cleared Oct 05, 1984
CONCEPT FIBER OPTIC CANALICULUS INTUBA
K843491 · HNL
Concept, Inc.
Ophthalmic · 29d
Cleared Oct 01, 1984
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG
K842197 · HQE
American Medical Optics
Ophthalmic · 119d
Cleared Oct 01, 1984
AMER. MEDICAL OPTICS DIGITAL KERATO-
K842504 · HQL
American Medical Optics
Ophthalmic · 97d