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
1321–1344 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 18, 2004
SELF RETAINING BICANALICULUS INTUBATION SET
K041869 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 132d
Cleared Nov 16, 2004
HYDROGEL CANALICULAR PLUG
K040912 · LZU
Partners IN Biomaterials, Inc.
Ophthalmic · 222d
Cleared Nov 16, 2004
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · HNO
Biovision AG
Ophthalmic · 105d
Cleared Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · LPL
CooperVision, Inc.
Ophthalmic · 35d
Cleared Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367 · HKI
Topcon Corp.
Ophthalmic · 165d
Cleared Nov 03, 2004
AQUIFY LENS COMFORT DROPS
K042176 · LPN
Ciba Vision Corporation
Ophthalmic · 84d
Cleared Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · LPN
Ciba Vision Corporation
Ophthalmic · 511d
Cleared Oct 28, 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
K042275 · LPL
Vistakon
Ophthalmic · 66d
Cleared Oct 28, 2004
CENTURION SES EPIKERATOME
K042810 · HNO
Norwood Abbey , Ltd.
Ophthalmic · 16d
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