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
1081–1104 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 12, 2009
ORBITAL RECONSTRUCTIVE IMPLANT II
K083342 · HPZ
Evera Medical, Inc.
Ophthalmic · 120d
Cleared Feb 27, 2009
EYE SPHERES
K082850 · HPZ
Product and Educational Services, LLC
Ophthalmic · 151d
Cleared Feb 27, 2009
IMAG, IPOD, EZ-FIND AND ISLIDE
K090362 · LRX
Voguestrap
Ophthalmic · 14d
Cleared Feb 12, 2009
INFINITI VISION SYSTEM WITH OZIL IP
K082845 · HQC
Alcon Research, Ltd.
Ophthalmic · 139d
Cleared Jan 30, 2009
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
K083771 · HKI
Clarity Medical Systems
Ophthalmic · 43d
Cleared Jan 27, 2009
HDS HI 1.54
K082799 · HQD
Paragon Vision Sciences
Ophthalmic · 126d
Cleared Jan 22, 2009
IMAGE STORAGE SYSTEM, MODEL KSS-400
K081797 · NFJ
Konan Medical, Inc.
Ophthalmic · 211d
Cleared Jan 16, 2009
EPIVISION SL SYSTEM
K072102 · HNO
Gebauer Medizintechnik GmbH
Ophthalmic · 535d
Cleared Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
K083387 · HKI
Kowa Co. , Ltd.
Ophthalmic · 60d
Cleared CT Jan 13, 2009
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF...
K072971 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 449d
Cleared Jan 05, 2009
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
K081877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 187d
Cleared Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K082473 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 131d
Cleared Dec 17, 2008
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT...
K080794 · LPL
Polyvue Distribution, Inc.
Ophthalmic · 272d
Cleared Dec 15, 2008
CENEFOM PVA SURGICAL SPEAR
K082460 · HOZ
Longtek Scientific Co., Ltd.
Ophthalmic · 111d
Cleared Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
K073087 · HKX
Tomey Corporation
Ophthalmic · 383d
Cleared Nov 14, 2008
SPECTRAL OCT/SLO
K080460 · OBO
Opko Health, Inc.
Ophthalmic · 268d
Cleared Nov 05, 2008
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K081858 · HKI
Clarity Medical Systems
Ophthalmic · 127d
Cleared Oct 23, 2008
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
K081382 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 160d
Cleared Oct 21, 2008
KOWA NONMYD ALPHA-DIII
K082767 · HKI
Kowa Co. , Ltd.
Ophthalmic · 29d
Cleared Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 14d
Cleared Oct 15, 2008
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
K080632 · MVN
Clearlab SG Pte, Ltd.
Ophthalmic · 224d
Cleared Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT...
K081178 · HQD
Contamac, Ltd.
Ophthalmic · 167d
Cleared Oct 08, 2008
VITRECTOMY CUTTER AND ACCESSORIES
K081681 · MLZ
Advanced Medical Optics, Inc.
Ophthalmic · 113d
Cleared Oct 02, 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K081545 · MSS
Advanced Medical Optics, Inc.
Ophthalmic · 122d