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
4441–4464 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 02, 1985
SKIASCOPIC RACKS
K844364 · HMH
Luneau Laboratories
Ophthalmic · 50d
Cleared Jan 02, 1985
COLOR VISION TESTERS
K844365 · HIT
Luneau Laboratories
Ophthalmic · 50d
Cleared Dec 27, 1984
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · HQC
Chiron Vision Corp.
Ophthalmic · 27d
Cleared Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
K844761 · HOY
Medical Instrument Development...
Ophthalmic · 17d
Cleared Dec 19, 1984
MVS XII
K842793 · HQE
Medical Instrument Development...
Ophthalmic · 155d
Cleared Dec 19, 1984
INFUSION ASPIRATION VITRECTOMY SYS
K843391 · HQE
Medical Instrument Development...
Ophthalmic · 112d
Cleared Dec 19, 1984
CANON AUTO KERATOMETER K-1
K844054 · HLI
Canon USA, Inc.
Ophthalmic · 62d
Cleared Dec 18, 1984
LANDERS-FOULKS TEMP. KERATOPROSTHESIS
K842856 · MLP
Ocular Instruments, Inc.
Ophthalmic · 151d
Cleared Dec 13, 1984
LASERSPEC
K841430
Clement Clarke, Inc.
Ophthalmic · 251d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES, CUSTOM
K842187 · HQG
Pavuna , Ltd.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE-LENS, SPECTACLES, CUSTOM
K842188 · HQE
Gold Cadillac Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES CUSTOM
K842189 · HQG
Hanmy Optical Industrial Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
COOPERVISION SYSTEM VI
K842945 · HQC
CooperVision, Inc.
Ophthalmic · 139d
Cleared Dec 11, 1984
WOODLYN CLASSIC CATARACT ACUITY TEST
K843812 · HLI
Woodlyn, Inc.
Ophthalmic · 74d
Cleared Dec 11, 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · HQC
American Medical Optics
Ophthalmic · 48d
Cleared Dec 11, 1984
OPHTHALMIC CHAIR
K844362 · HMF
Luneau Laboratories
Ophthalmic · 28d
Cleared Dec 11, 1984
O.M.S. GUILLOTINE CUTTER
K844374 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 28d
Cleared Dec 11, 1984
OMS SCISSORS
K844510 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 21d
Cleared Dec 11, 1984
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · HNN
Codman & Shurtleff, Inc.
Ophthalmic · 20d
Cleared Dec 11, 1984
SPECTABLE FRAME MAGNIFYING BRILLETTE
K844657 · HOJ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 11, 1984
SPECTABLE FRAME - PRODESIGN SUN CLUB
K844658 · HQZ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 05, 1984
OPHTHALMIC STAND
K844363 · HMF
Luneau Laboratories
Ophthalmic · 22d