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
1993–2016 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 20, 1997
FLEXLENS, FLEXLENS TORIC
K973192 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 87d
Cleared Nov 20, 1997
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · LPL
Martin Dalsing
Ophthalmic · 59d
Cleared Nov 20, 1997
VENNETO
K974045 · HQY
Amsure Sports, Inc.
Ophthalmic · 27d
Cleared Nov 18, 1997
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
K973293 · MPA
Vaughan Weeks
Ophthalmic · 77d
Cleared Nov 18, 1997
SUNGLASSES
K973934 · HQY
Elegance Optical Manufactory, Ltd.
Ophthalmic · 34d
Cleared Nov 14, 1997
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
K973290 · MPA
Vaughan Weeks
Ophthalmic · 73d
Cleared Nov 13, 1997
EYE SYS VISTA
K973756 · HLQ
Eyesys Technologies, Inc.
Ophthalmic · 42d
Cleared Nov 07, 1997
D.O.R.C. SOLUX LIGHT SOURCE
K973757 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 36d
Cleared Nov 04, 1997
NIDEK HANDY
K973218 · HKI
Nidek, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1997
RODENSTOCK LASER SLITLAMP
K973220 · HQF
G. Rodenstock Instrumente GmbH
Ophthalmic · 69d
Cleared Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · HKI
Nidek, Inc.
Ophthalmic · 47d
Cleared Oct 24, 1997
HANSATOME MICROKERATOME
K972808 · HNO
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Oct 16, 1997
MOA BONE / M-SPHERE
K972143 · HPZ
Iop, Inc.
Ophthalmic · 132d
Cleared Oct 16, 1997
SUNGLASSES
K973526 · HQY
Pyramid Handbags, Inc.
Ophthalmic · 28d
Cleared Oct 15, 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN...
K972807 · LPL
Benz Research and Development Corp.
Ophthalmic · 79d
Cleared Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664 · MRH
Storz Instrument Co.
Ophthalmic · 86d
Cleared Oct 10, 1997
CBALK-1000 BLADE
K972727 · HNO
Howard Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 03, 1997
LASEREX LP1532 PHOTOCOAGULATOR
K972514 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 88d
Cleared Oct 03, 1997
EYE SPHERE, CONFORMERS
K972661 · HPZ
Gulden Ophthalmics
Ophthalmic · 79d
Cleared Oct 03, 1997
INNOVATOME MICROKERATOME
K973294 · HNO
Innovative Optics, Inc.
Ophthalmic · 31d
Cleared Oct 01, 1997
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
K972506 · HJM
Infinitech, Inc.
Ophthalmic · 90d
Cleared Sep 30, 1997
CATARACTSCREENER CT - S
K972440 · HKI
Neitz Instruments Company, Ltd.
Ophthalmic · 92d
Cleared Sep 30, 1997
ML-DISPOSABLE PAK
K972522 · MSR
Med-Logics, Inc.
Ophthalmic · 85d
Cleared Sep 30, 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · HOZ
Deroyal Industries, Inc.
Ophthalmic · 74d