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
1201–1224 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 06, 2006
CRYOMATIC
K062412 · HRN
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Nov 01, 2006
KOWA VX-10I
K062021 · HKI
Kowa Co. , Ltd.
Ophthalmic · 107d
Cleared Nov 01, 2006
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · HQD
Contamac, Ltd.
Ophthalmic · 63d
Cleared Nov 01, 2006
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED...
K062614 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 57d
Cleared Oct 31, 2006
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
K063191 · OBO
Heidelberg Engineering
Ophthalmic · 11d
Cleared Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
K062295 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 74d
Cleared Oct 13, 2006
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895 · MPA
Dutch Ophthalmic Research Center...
Ophthalmic · 16d
Cleared Oct 06, 2006
RTVUE
K062552 · OBO
Optovue, Inc.
Ophthalmic · 37d
Cleared Sep 28, 2006
MP-1 MICROPERIMETER
K061768 · HKI
Nidek Technologies Srl
Ophthalmic · 97d
Cleared Sep 27, 2006
MOLTENO3
K062252 · KYF
Iop, Inc.
Ophthalmic · 55d
Cleared Sep 27, 2006
KOWA NONMYD ALPHA-D
K062356 · HKI
Kowa Co. , Ltd.
Ophthalmic · 44d
Cleared Sep 18, 2006
AHMED GLAUCOMA VALVE, MODEL M4
K060644 · KYF
New World Medical, Inc.
Ophthalmic · 192d
Cleared Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 13d
Cleared Aug 23, 2006
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
K061674 · HLI
Talia Technology , Ltd.
Ophthalmic · 70d
Cleared Aug 15, 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
K062259 · MPA
Iscience Surgical
Ophthalmic · 11d
Cleared Aug 08, 2006
ORBITAL TISSUE EXPANDER (OTE)
K060151 · NFM
Innovia, LLC
Ophthalmic · 200d
Cleared Aug 07, 2006
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
K061404 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 80d
Cleared Jul 11, 2006
SNUG PLUG PUNCTUM PLUG
K061398 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 53d
Cleared Jun 28, 2006
JSZ MULTIACTION GP CONTACT LENS SOLUTION
K060924 · LPN
Szabocsik and Associates
Ophthalmic · 85d
Cleared Jun 22, 2006
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
K061120 · HQD
Synergeyes, Inc.
Ophthalmic · 62d
Cleared Jun 22, 2006
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K061157 · MVN
Bausch & Lomb
Ophthalmic · 57d
Cleared Jun 21, 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K061024 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 69d
Cleared Jun 09, 2006
KOWA KT-800
K053444 · HKX
Kowa Co. , Ltd.
Ophthalmic · 182d
Cleared May 31, 2006
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · LPN
Lapis Lazuli, NV
Ophthalmic · 394d