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
1465–1488 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 01, 2002
STEPHENS DISPOSABLE FORCEPS
K022835 · HNR
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
K022836 · HNC
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SCISSORS
K022840 · HNF
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE HOOKS
K022842 · HNQ
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
GAYHEART CORNEAL EXCISION DEVICE
K022843 · HRH
Stephens Instruments
Ophthalmic · 66d
Cleared Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
K021635 · LPN
Ciba Vision Corporation
Ophthalmic · 164d
Cleared Oct 21, 2002
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
K023245 · NJJ
Paradigm Medical Industries, Inc.
Ophthalmic · 21d
Cleared Oct 18, 2002
SMART PLUG, MODEL 500
K022043 · LZU
Medennium, Inc.
Ophthalmic · 116d
Cleared Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
K023092 · HMY
Becton, Dickinson & CO
Ophthalmic · 30d
Cleared Oct 18, 2002
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K023249 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 18d
Cleared Oct 16, 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · LZU
Moist Medical, Inc.
Ophthalmic · 126d
Cleared Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · HMY
Becton, Dickinson & CO
Ophthalmic · 69d
Cleared Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
K013805 · HKX
Kowa Optimed, Inc.
Ophthalmic · 330d
Cleared Oct 11, 2002
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS...
K021752 · HQD
Lucid Korea Co., Ltd.
Ophthalmic · 136d
Cleared Oct 11, 2002
TGDC-01 PRA
K021937 · HKX
Truevision Instruments
Ophthalmic · 121d
Cleared Oct 11, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
K022716 · HNO
Med-Logics, Inc.
Ophthalmic · 57d
Cleared Oct 11, 2002
CONTACT LASER & DIAGNOSTIC LENSES
K023221 · HJK
Volk Optical, Inc.
Ophthalmic · 14d
Cleared Oct 07, 2002
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
K022373 · NJH
Cantor & Nissel , Ltd.
Ophthalmic · 77d
Cleared Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · HNO
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Sep 27, 2002
M2 SINGLE USE MICROKERTOME
K022560 · HMY
Moria SA
Ophthalmic · 56d
Cleared Sep 26, 2002
MICRORUPTER V
K023045 · LXS
Meridian AG
Ophthalmic · 14d
Cleared Sep 24, 2002
ICASE
K021248 · LRX
Ikeeps, Inc.
Ophthalmic · 158d
Cleared Sep 24, 2002
LUNEAU 3 MIRROR LENS
K022413 · HJK
Luneau SA
Ophthalmic · 62d
Cleared Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · HQD
Contamac, Ltd.
Ophthalmic · 87d