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
841–864 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 11, 2013
ICAM FUNDUS CAMERA
K122572 · HKI
Optovue, Inc.
Ophthalmic · 141d
Cleared Jan 02, 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K122273 · MRC
Menicon Co, Ltd.
Ophthalmic · 156d
Cleared Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481 · HKI
Tearscience, Inc.
Ophthalmic · 139d
Cleared Dec 21, 2012
CENTURION VISION SYSTEM
K121555 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 210d
Cleared Dec 20, 2012
PANOPTIC
K121405 · HKI
Welch Allyn, Inc.
Ophthalmic · 224d
Cleared Dec 20, 2012
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS,...
K122575 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Dec 17, 2012
LACRIFAST
K120886 · OKS
Hiroyasu Higuchi
Ophthalmic · 269d
Cleared Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K122213 · LPL
Soflex Limited
Ophthalmic · 140d
Cleared Dec 12, 2012
LENSX LASER SYSTEM
K123120 · OOE
Alcon Lensx, Inc.
Ophthalmic · 70d
Cleared Dec 03, 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K122829 · HQC
Lensar, Inc.
Ophthalmic · 77d
Cleared Nov 26, 2012
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904 · LRX
Reliance Design & Manufacture Corp.
Ophthalmic · 245d
Cleared Nov 13, 2012
PASCAL LASER INDIRECT OPHTHALMOSCOPE
K123056 · HQF
Topcon Medical Laser Systems, Inc....
Ophthalmic · 43d
Cleared Nov 08, 2012
CORVIS ST
K113066 · HKX
Oculus Optikgerate GmbH
Ophthalmic · 388d
Cleared Nov 08, 2012
DCS LACRIMAL STENT
K113316 · OKS
Dcs Surgical, Inc.
Ophthalmic · 365d
Cleared Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 39d
Cleared Oct 26, 2012
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
K121201 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 190d
Cleared Oct 25, 2012
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT,...
K121993 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 111d
Cleared Oct 19, 2012
LACRICATH LACRIMAL DUCT CATHETER
K113867 · OKS
Quest Medical, Inc.
Ophthalmic · 294d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d
Cleared Oct 05, 2012
CVUE ADVANCED HYDRA VUE
K121652 · LPL
Unilens Corp., USA
Ophthalmic · 122d
Cleared Oct 03, 2012
EK DELIVERY DEVICE
K121579 · OTZ
Tdak Medical, Inc.
Ophthalmic · 126d
Cleared Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
K113852 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 274d
Cleared Sep 28, 2012
DIGITAL EYE-FUNDUS CAMERA
K120982 · HKI
Medimaging Integrated Solutions, Inc....
Ophthalmic · 179d
Cleared Sep 18, 2012
ISIGHT
K121519 · LPL
C&E GP Specialists, Inc.
Ophthalmic · 119d