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
1177–1200 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 19, 2007
ORBITAL RECONSTRUCTIVE IMPLANT
K070130 · HPZ
Becker & Associates Consulting, Inc.
Ophthalmic · 93d
Cleared Apr 13, 2007
STARION UNIVERSAL POWER SUPPLY
K070871 · HQO
Starion Instruments
Ophthalmic · 15d
Cleared Mar 27, 2007
MONARCH III IOL DELIVERY SYSTEM
K063155 · KYB
Alcon Manufacturing, Ltd.
Ophthalmic · 161d
Cleared Mar 27, 2007
MODIFICATION TO: OCU-FILM TIP COVER
K070534 · HKY
Reichert, Inc.
Ophthalmic · 29d
Cleared Mar 19, 2007
REPROCESSED PHACOEMULSIFICATION TIPS
K060648 · NKX
Alliance Medical Corp.
Ophthalmic · 371d
Cleared Mar 13, 2007
ELLEX SLIT LAMP, MODEL 30XL
K063352 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 127d
Cleared Mar 12, 2007
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B)...
K070308 · LPL
X-Cel Contacts
Ophthalmic · 39d
Cleared Mar 09, 2007
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
K062659 · HQP
Kirwan Surgical Products, Inc.
Ophthalmic · 183d
Cleared Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694 · KYB
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Feb 08, 2007
EUSOL-C
K063617 · LYX
Al.Chi.Mi.A
Ophthalmic · 65d
Cleared Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
K063378 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 79d
Cleared Jan 23, 2007
CF-1
K063717 · HKI
Canon, Inc.
Ophthalmic · 40d
Cleared Dec 20, 2006
XCEL 255 SLIT LAMP
K063750 · HJO
Reichert, Inc.
Ophthalmic · 1d
Cleared Dec 19, 2006
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 46d
Cleared Dec 18, 2006
KOWA SL-15
K063640 · HJO
Kowa Co. , Ltd.
Ophthalmic · 11d
Cleared Dec 13, 2006
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
K062612 · MSS
Rayner Surgical, Inc.
Ophthalmic · 99d
Cleared Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
K063343 · HLI
Bioptigen, Inc.
Ophthalmic · 37d
Cleared Dec 07, 2006
LUXVISION SLIT LAMP
K063416 · HJO
Us Ophthalmic, LLC
Ophthalmic · 24d
Cleared Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · MVN
CooperVision, Inc.
Ophthalmic · 135d
Cleared Nov 17, 2006
RETINAL FUNCTIONAL IMAGER (RFI)
K062416 · HKI
Optical Imaging , Ltd.
Ophthalmic · 92d
Cleared Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
K062074 · HQF
Iridex Corp
Ophthalmic · 116d
Cleared Nov 14, 2006
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC...
K062262 · LPL
Ciba Vision Corporation
Ophthalmic · 102d
Cleared Nov 08, 2006
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K062930 · NCF
Alcon Research, Ltd.
Ophthalmic · 41d
Cleared Nov 07, 2006
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D,...
K052599 · HLJ
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 412d