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
1609–1632 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · LPL
Vistakon
Ophthalmic · 51d
Cleared Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K010223 · LPL
American Contact Lens, Inc.
Ophthalmic · 51d
Cleared Mar 12, 2001
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
K010082 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 61d
Cleared Mar 12, 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY...
K010126 · LPL
Cl-Tinters
Ophthalmic · 55d
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ
Nidek Co., Ltd.
Ophthalmic · 140d
Cleared Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594 · HMY
Moria, Inc.
Ophthalmic · 108d
Cleared Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · HNO
Oasis Medical, Inc.
Ophthalmic · 87d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826 · MVN
Ciba Vision Corporation
Ophthalmic · 87d
Cleared Mar 08, 2001
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT...
K003861 · LPL
Benz Research and Development Corp.
Ophthalmic · 85d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · MUW
Paragon Vision Sciences
Ophthalmic · 47d
Cleared Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
K002515 · HNO
Med-Logics, Inc.
Ophthalmic · 191d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · MML
Iop, Inc.
Ophthalmic · 87d
Cleared Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · LPN
Allergan, Inc.
Ophthalmic · 127d
Cleared Feb 21, 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K003789 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 75d
Cleared Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT...
K003996 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 21, 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B)...
K004000 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 16, 2001
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
K003932 · HQD
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933 · MUW
Polymer Technology
Ophthalmic · 58d
Cleared Feb 13, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K001585 · LPL
American Biocurve, Inc.
Ophthalmic · 267d
Cleared Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · HQC
Allergan, Inc.
Ophthalmic · 81d
Cleared Feb 13, 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES...
K003833 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 64d
Cleared Feb 12, 2001
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY...
K003526 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 88d
Cleared Feb 08, 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K003512 · HQC
A.R.C. Laser AG
Ophthalmic · 86d
Cleared Feb 08, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
K003586 · MVN
Ciba-Geigy Corp.
Ophthalmic · 80d