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
1057–1080 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
K082880 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K082883 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
SUPRA 577.Y LASER
K091581 · HQF
Quantel Medical
Ophthalmic · 14d
Cleared Jun 09, 2009
EPIPHANY INJECTION SYSTEM
K090161 · MSS
Staar Surgical Co.
Ophthalmic · 138d
Cleared Jun 04, 2009
FLOW CONTROLLER
K090938 · LZU
Odyssey Medical, Inc.
Ophthalmic · 62d
Cleared May 20, 2009
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K083921 · HQD
Synergeyes, Inc.
Ophthalmic · 140d
Cleared May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K090078 · NXM
Iop, Inc.
Ophthalmic · 116d
Cleared May 06, 2009
MATCHEDFLICKER
K090266 · NFJ
Eyeic Corporation
Ophthalmic · 92d
Cleared May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES,...
K083291 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 179d
Cleared Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · LPL
Ciba Vision Corporation
Ophthalmic · 165d
Cleared Mar 25, 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K081946 · HQF
Quantel Medical
Ophthalmic · 260d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Mar 23, 2009
HOYA IS INJECTOR SYSTEM
K081346 · MSS
Hoya Surgical Optics, Inc.
Ophthalmic · 313d
Cleared Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · HKI
Canon, Inc.
Ophthalmic · 30d
Cleared Mar 13, 2009
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K083316 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 123d
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