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
1633–1656 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Feb 07, 2001
BIO-EYE II ORBITAL IMPLANT
K003338 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 105d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · HLI
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Jan 22, 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A...
K003042 · LPL
Joe B. Goldberg, O.D.
Ophthalmic · 115d
Cleared Jan 06, 2001
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT...
K003136 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 92d
Cleared Jan 05, 2001
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
K003031 · LPN
Alpha Vista, Inc.
Ophthalmic · 99d
Cleared Jan 05, 2001
MONARCH II IOL DELIVERY SYSTEM
K003768 · MSS
Alcon Research, Ltd.
Ophthalmic · 30d
Cleared Jan 04, 2001
PHACOGARD
K002932 · HQC
Syntec, Inc.
Ophthalmic · 106d
Cleared Dec 27, 2000
PHACOFRAGMENTATION SYSTEM MEGATRON
K002031 · HQC
Asclepion-Meditec AG
Ophthalmic · 177d
Cleared Dec 22, 2000
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL...
K003036 · KYG
Retinalabs.Com
Ophthalmic · 84d
Cleared Dec 22, 2000
PEDIATRIC INGESTASCAN
K003305 · HPM
Adams Electronics, Inc.
Ophthalmic · 63d
Cleared Dec 18, 2000
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · HKI
Escalon Medical Corp.
Ophthalmic · 90d
Cleared Dec 15, 2000
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K003161 · LPL
Les Laboratoires Blanchard
Ophthalmic · 66d
Cleared Dec 15, 2000
RYTHMIC AND RYTHMIC UV
K003170 · LPL
Essilor Intl.
Ophthalmic · 66d
Cleared Dec 13, 2000
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K003071 · LPL
Ciba Vision Corporation
Ophthalmic · 72d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · HKX
Xomed, Inc.
Ophthalmic · 126d