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
1321–1344 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 26, 2004
COOPER PROSTHETIC
K042435 · LPL
CooperVision, Inc.
Ophthalmic · 48d
Cleared Oct 19, 2004
COMPLETE BLINK-N-CLEAN LENS DROPS
K040839 · MRC
Advanced Medical Optics, Inc.
Ophthalmic · 202d
Cleared Oct 13, 2004
MB 105 MILLENNIUM BLADES
K041110 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 168d
Cleared Oct 13, 2004
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · MXK
Heidelberg Engineering
Ophthalmic · 9d
Cleared Oct 08, 2004
THE FUGO BLADE FOR GLAUCOMA
K041019 · NCR
Medisurg , Ltd.
Ophthalmic · 171d
Cleared Oct 07, 2004
PANORAMIC 200A
K042001 · HLI
Optos Plc.
Ophthalmic · 73d
Cleared Oct 06, 2004
LASEREX, MODEL LP4532
K041598 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 114d
Cleared Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K040209 · HQF
Iridex Corp
Ophthalmic · 234d
Cleared Sep 16, 2004
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND...
K033599 · HQD
The Lagado Corp.
Ophthalmic · 307d
Cleared Sep 15, 2004
EPITOME SYSTEM
K041206 · HNO
Gebauer Medizintechnik GmbH
Ophthalmic · 131d
Cleared Sep 15, 2004
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
K042242 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 27d
Cleared Sep 02, 2004
PATHFINDER
K031788 · MXK
Massie Research Laboratories, Inc.
Ophthalmic · 450d
Cleared Aug 30, 2004
CARRIAZO PENDULAR
K032910 · HNO
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 343d
Cleared Aug 16, 2004
PHACO CHOP NEEDLES
K041998 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 21d
Cleared Jul 30, 2004
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR...
K033655 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 252d
Cleared Jul 30, 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
K041700 · LPL
Cantor & Nissel , Ltd.
Ophthalmic · 38d
Cleared Jul 23, 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · MXK
Bausch & Lomb
Ophthalmic · 106d
Cleared Jul 23, 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jul 16, 2004
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · HPZ
Porex Surgical, Inc.
Ophthalmic · 107d
Cleared Jul 13, 2004
INTELIPORT OCCLUDING DEVICE
K040231 · LZU
Alcon, Inc.
Ophthalmic · 162d
Cleared Jul 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
K041608 · LPL
Unilens Corp., USA
Ophthalmic · 22d
Cleared Jul 02, 2004
VARILUX VISIONPRINT SYSTEM (VPS)
K033949 · HLL
Essilor Intl.
Ophthalmic · 196d
Cleared Jun 23, 2004
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · HKI
Canon, Inc.
Ophthalmic · 14d
Cleared Jun 22, 2004
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
K041108 · MPA
Iscience Surgical Corporation
Ophthalmic · 55d