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
1633–1656 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
K003143 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 62d
Cleared Dec 08, 2000
PAFLUFOCON C AND E DAILY CONTACT LENS
K002845 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Nov 29, 2000
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K002986 · HQC
A.R.C. Laser AG
Ophthalmic · 65d
Cleared Nov 21, 2000
O-PERM 30
K002703 · HQD
Optical Polymer Research, Inc.
Ophthalmic · 83d
Cleared Nov 21, 2000
SPECIALTY TINT SOFT CONTACT LENS
K003079 · LPL
Specialty Tint
Ophthalmic · 49d
Cleared Nov 21, 2000
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · LPN
Allergan, Inc.
Ophthalmic · 48d
Cleared Nov 08, 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K002812 · HQC
Michael Reynard, M.D.
Ophthalmic · 61d
Cleared Nov 08, 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B)...
K002966 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 47d
Cleared Nov 02, 2000
RETINADX
K003236 · HKI
Regulatory Associates, Inc.
Ophthalmic · 16d