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
745–768 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI...
K133740 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 86d
Cleared 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
Cleared Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K132534 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 185d
Cleared Feb 14, 2014
STELLARIS VISION ENHANCEMENT SYSTEM
K133242 · HQC
Bausch & Lomb
Ophthalmic · 116d
Cleared Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930 · LRX
Ningbo Lishunda Electronics Co., Ltd.
Ophthalmic · 314d
Cleared Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · LPL
Ciba Vision Corporation
Ophthalmic · 104d
Cleared Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
K131958 · MSS
Bausch & Lomb
Ophthalmic · 196d
Cleared Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
K133146 · MSS
Bausch & Lomb
Ophthalmic · 78d
Cleared Dec 27, 2013
EASY-LOAD LENS DELIVERY SYSTEM
K132481 · MSS
Bausch & Lomb
Ophthalmic · 141d
Cleared Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · HRN
Keeler, Ltd.
Ophthalmic · 188d