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
1393–1416 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Jul 14, 2003
INJECTOR
K023737 · MSS
Anton Meyer & Co. , Ltd.
Ophthalmic · 249d
Cleared Jul 03, 2003
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
K031193 · LPN
Alcon, Inc.
Ophthalmic · 78d
Cleared Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · HNO
Oasis Medical, Inc.
Ophthalmic · 133d
Cleared Jun 17, 2003
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
K030891 · HNO
Surgistar, Inc.
Ophthalmic · 88d
Cleared Jun 17, 2003
VMATE MODEL VMM1000
K030948 · HQE
Howard Instruments, Inc.
Ophthalmic · 83d
Cleared Jun 12, 2003
CONTACT LENS STORAGE CASE
K030987 · LRX
Pelican Products
Ophthalmic · 76d