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
3433–3456 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 14, 1991
EYE SEE INSTRUMENT
K905237 · HPN
King Tool, Inc.
Ophthalmic · 90d
Cleared Feb 13, 1991
PRIMARY MANUFACTURER SUNGLASSES
K903065 · HQY
Mao Lin Ent.
Ophthalmic · 219d
Cleared Feb 13, 1991
CHILDREN SUNGLASSES
K910141 · HQY
Consolidated Stores Intl. Corp.
Ophthalmic · 30d
Cleared Feb 11, 1991
BAERVELDT GLAUCOMA IMPLANT
K905129 · KYF
Wright Medical Corp.
Ophthalmic · 89d
Cleared Feb 11, 1991
CENTAURI
K905141 · HQF
Pfizer Laser Systems
Ophthalmic · 88d
Cleared Feb 05, 1991
SUNGLASSES
K905041 · HQY
Eskco, Inc.
Ophthalmic · 90d
Cleared Jan 28, 1991
I/A VITROPHAGE MODEL YPR 2001
K904909 · HQE
Visioncare Devices, Inc.
Ophthalmic · 89d
Cleared Jan 28, 1991
FUNKY SUNGLASS
K904981 · HQY
Monogram International,Inc.
Ophthalmic · 87d
Cleared Jan 28, 1991
NMR-K FUNDUS LASER LENS
K910231 · HJK
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Jan 23, 1991
JMB TRADING COMPANY SUNGLASSES
K904161 · HQY
Jmb Trading Co.
Ophthalmic · 134d
Cleared Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · HNO
Storz Instrument Co.
Ophthalmic · 89d
Cleared Jan 18, 1991
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
K904828 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Dec 26, 1990
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
K904612 · HQC
Medical Technical Products
Ophthalmic · 76d
Cleared Dec 21, 1990
THE VISONIC DOME(TM)
K902306 · LYL
Vista Vision
Ophthalmic · 213d
Cleared Dec 21, 1990
CHIROFLEX FORCEPS
K903575 · KYB
Chiron Ophthalmics
Ophthalmic · 135d
Cleared Dec 18, 1990
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
K903421 · HQF
Top Con
Ophthalmic · 140d
Cleared Dec 13, 1990
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
K901605 · LXS
Phoenix Laser Systems, Inc.
Ophthalmic · 252d
Cleared Dec 07, 1990
CHILDRENS SUNGLASSES
K902225 · HQY
Jasco Products Co., Inc.
Ophthalmic · 204d
Cleared Dec 05, 1990
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
K904151 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 89d
Cleared Dec 05, 1990
SITE PHACOEMULSIFICATION HANDPIECE
K904183 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 84d
Cleared Nov 21, 1990
SITE DIAPHRAGM CASSETTE
K904186 · KYG
Site Microsurgical Systems, Inc.
Ophthalmic · 70d
Cleared Nov 21, 1990
NONPRESCRIPTION SUNGLASSES
K904281 · HQY
Jennie G. Sales Co., Inc.
Ophthalmic · 65d
Cleared Nov 19, 1990
OPHTHASONIC A/P III
K903666 · HPY
Teknar, Inc.
Ophthalmic · 97d
Cleared Nov 05, 1990
SOLARSHIELDS ENCORE
K903487 · HQY
Dioptics
Ophthalmic · 97d