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
985–1008 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · HKX
Keeler Instruments, Inc.
Ophthalmic · 415d
Cleared Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · HLJ
American Diagnostic Corp.
Ophthalmic · 374d
Cleared Nov 17, 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071 · HKI
Fundus Photo, LLC
Ophthalmic · 413d
Cleared Nov 12, 2010
CONSTELLATION VISION SYSTEM
K101285 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 189d
Cleared Nov 03, 2010
IOLMASTER 500
K101182 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 190d
Cleared Oct 29, 2010
DIGITAL RETINAL CAMERA
K102013 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 105d
Cleared Oct 28, 2010
METRO SOFT
K100244 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 274d
Cleared Oct 28, 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · LPL
X-Cel Contacts, Inc.
Ophthalmic · 253d
Cleared Oct 28, 2010
CVUE ADVANCED DEFINITIVE
K100456 · LPL
Unilens Corp., USA
Ophthalmic · 253d
Cleared Oct 27, 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · HKI
Centervue S.P.A.
Ophthalmic · 107d
Cleared Oct 18, 2010
LENSX LASER SYSTEM
K101626 · OOE
Lensx Lasers, Inc.
Ophthalmic · 131d
Cleared Oct 01, 2010
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA,...
K101223 · OBO
Heidelberg Engineering
Ophthalmic · 151d
Cleared Sep 30, 2010
P200MAAF
K102492 · MYC
Optos Plc.
Ophthalmic · 30d
Cleared Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · LPN
Abbott Medical Optics, Inc.
Ophthalmic · 334d
Cleared Sep 15, 2010
RTVUE MODEL RTVUE 100
K101505 · HLI
Optovue, Inc.
Ophthalmic · 106d
Cleared Sep 14, 2010
INTELLIWAVE3
K100221 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 231d
Cleared Sep 10, 2010
STERILE SALINE SOLUTION
K093367 · LPN
Cachet Pharmaceuticals Pvt. , Ltd.
Ophthalmic · 316d
Cleared Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 97d
Cleared Aug 09, 2010
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
K101122 · LPL
Benz Research and Development Corp.
Ophthalmic · 110d
Cleared Aug 09, 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K101134 · MSS
Medicel AG
Ophthalmic · 109d
Cleared Jul 16, 2010
MEDIWORKS SLIT LAMP
K100439 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 149d
Cleared Jul 15, 2010
OPTOS LIMITED PANORAMIC 200CAF
K100644 · MYC
Optos Plc.
Ophthalmic · 132d
Cleared Jul 08, 2010
VISUMAX LASER KERATOME
K100253 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 161d
Cleared Jun 25, 2010
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP...
K091327 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 416d