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
745–768 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 05, 2014
ALADDIN
K131567 · HJO
Visia Imaging S.R.L.
Ophthalmic · 371d
Cleared Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · LZU
Lacrimedics, Inc.
Ophthalmic · 148d
Cleared May 28, 2014
RAYSERT PLUS INJECTOR
K141091 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared May 09, 2014
YZ3 PORTABLE SLIT LAMP
K131711 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 332d
Cleared Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
K140368 · HKS
Sensor Medical Technology, LLC
Ophthalmic · 74d
Cleared Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042 · HOY
X6d, Ltd.
Ophthalmic · 300d
Cleared Apr 23, 2014
ACCUTIP COVER
K132549 · HKY
Accutome, Inc.
Ophthalmic · 252d
Cleared Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · HLI
Centervue S.P.A.
Ophthalmic · 133d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039 · MYC
Optos Plc.
Ophthalmic · 101d
Cleared Mar 27, 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED...
K132002 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 269d
Cleared Mar 26, 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · HLI
Amico Diagnostic Incorporated
Ophthalmic · 272d
Cleared Mar 21, 2014
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K133735 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Mar 19, 2014
CIRRUS PHOTO
K133217 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 152d
Cleared Mar 19, 2014
IVUE 500
K133892 · HLI
Optovue, Inc.
Ophthalmic · 89d
Cleared Mar 12, 2014
STELLARIS PC VISION ENHANCEMENT SYSTEM
K133486 · HQC
Bausch & Lomb
Ophthalmic · 119d
Cleared Mar 11, 2014
KOWA SL-17
K133755 · HJO
Kowa Co. , Ltd.
Ophthalmic · 92d
Cleared Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
K131959 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 253d
Cleared Mar 05, 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR,...
K132714 · LPL
Vision Science Co., Ltd.
Ophthalmic · 187d
Cleared CT Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI...
K133740 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 86d
Cleared CT Mar 04, 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
K133472 · LPL
Souflon Pharmaceuticals, Ltd.
Ophthalmic · 112d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Feb 21, 2014
POLAROID CONTACTSPOD
K131783 · LRX
Viopti, Ltd.
Ophthalmic · 249d
Cleared Feb 21, 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · HKY
Keeler Limited
Ophthalmic · 123d
Cleared Feb 19, 2014
RS-3000 ADVANCE
K132323 · OBO
Nidek Co., Ltd.
Ophthalmic · 209d