Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
1465–1488 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 13, 2002
HA ORBITAL IMPLANT
K021643 · HPZ
Laboratoire Villanova
Ophthalmic · 207d
Cleared Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
K023077 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 85d
Cleared Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K023732 · LPL
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Nov 26, 2002
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
K023530 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 36d
Cleared Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
K023816 · HKX
Canon, Inc.-Utsunomiya Optical...
Ophthalmic · 11d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ
Nidek, Inc.
Ophthalmic · 377d
Cleared Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · LYL
Ciba Vision Corporation
Ophthalmic · 98d
Cleared Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K022982 · HNO
Med-Logics, Inc.
Ophthalmic · 67d
Cleared Nov 07, 2002
FUNDUS AUTOIMAGER
K020888 · HKI
Visual Pathways, Inc.
Ophthalmic · 234d
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