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
1393–1416 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 04, 2003
THERATEARS CONTACT LENS COMFORT DROPS
K032481 · LPN
Advanced Vision Research, Inc.
Ophthalmic · 84d
Cleared Nov 04, 2003
COLIBRI DISPOSABLE VITRECTOMY CUTTER
K033390 · HQE
Microworld Medical Instruments, Inc.
Ophthalmic · 12d
Cleared Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978 · HNO
Ciba Vision Corporation
Ophthalmic · 26d
Cleared Oct 16, 2003
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
K032340 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 79d
Cleared Oct 10, 2003
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
K030910 · LPN
Clued UP Limited
Ophthalmic · 200d
Cleared Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 300d
Cleared Sep 25, 2003
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · MXK
Haag-Streit Holding AG
Ophthalmic · 232d
Cleared Sep 25, 2003
BLINK CL LUBRICANT EYE DROPS
K032030 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 86d
Cleared Sep 23, 2003
EYESOPEN TONOMETER
K032769 · HKY
Eye-Deas, LLC
Ophthalmic · 15d
Cleared Sep 17, 2003
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
K023758 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 313d
Cleared Sep 16, 2003
PENTACAM SCHEIMPFLUG CAMERA
K030719 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 193d
Cleared Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · LPN
Ciba Vision Corporation
Ophthalmic · 205d
Cleared Aug 29, 2003
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B)...
K032256 · LPL
No 7 Contact Lens Laboratory , Ltd.
Ophthalmic · 38d
Cleared Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K031665 · HQF
Iridex Corp
Ophthalmic · 90d
Cleared Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · HNO
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Aug 22, 2003
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
K023400 · HPZ
Fci Ophthalmics, Inc.
Ophthalmic · 317d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735 · HNO
Ciba Vision Corporation
Ophthalmic · 78d
Cleared Aug 20, 2003
PERFECT CAPSULE
K030957 · HQC
Milvella Pty. , Ltd.
Ophthalmic · 146d
Cleared Aug 14, 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · LPN
Ciba Vision Corporation
Ophthalmic · 50d
Cleared Aug 11, 2003
LED HEADLIGHT
K031548 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
SOLID STATE LAMP [LED] HEADLIGHT
K031549 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 01, 2003
SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT...
K031532 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 78d
Cleared Jul 30, 2003
SAUFLON MULTIPURPOSE SOLUTION - NO RUB
K030278 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 184d
Cleared Jul 18, 2003
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS
K031477 · LPL
Ocular Sciences, Inc.
Ophthalmic · 70d