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
1009–1032 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 02, 2010
ENHANCED ULTRA VIT PROBE
K093305 · MLZ
Alcon Research, Ltd.
Ophthalmic · 162d
Cleared Mar 19, 2010
SLIT LAMP BO 900, BQ 900, BP900
K100202 · HJO
Haag-Streit AG
Ophthalmic · 53d
Cleared Mar 18, 2010
DIGITAL RETINAL CAMERA CX-1
K092565 · HKI
Canon Components, Inc.
Ophthalmic · 210d
Cleared Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · HPT
Carl Zeiss Meditec, Inc.
Ophthalmic · 150d
Cleared Mar 11, 2010
SAVIEW 58 UV
K092852 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 176d
Cleared Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · MRC
Menicon Co, Ltd.
Ophthalmic · 526d
Cleared Mar 09, 2010
PSL CLASSIC SLIT LAMP
K100500 · HJO
Keeler Instruments, Inc.
Ophthalmic · 15d
Cleared Mar 04, 2010
AQUALASE CAPSULE WASH TIP
K093210 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 142d
Cleared Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · HKI
Topcon Corp.
Ophthalmic · 18d
Cleared Jan 28, 2010
ATLANTIS SLIT LAMP
K093021 · HJO
Us Opthalmic, LLC
Ophthalmic · 121d
Cleared Jan 19, 2010
KEELER APPLANATION TONOMETER
K093445 · HKY
Keeler, Ltd.
Ophthalmic · 90d
Cleared Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · LPL
CooperVision, Inc.
Ophthalmic · 244d
Cleared Dec 23, 2009
FORESEE HOME
K091579 · HPT
Notal Vision , Ltd.
Ophthalmic · 204d
Cleared Dec 18, 2009
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS,...
K090806 · LPL
Safilens, S.R.L.
Ophthalmic · 268d
Cleared Dec 18, 2009
LED LAMP OR OTHER
K092883 · HJO
Intravista Medical Systems, Inc.
Ophthalmic · 91d
Cleared Dec 11, 2009
LENSX 550 LASER SYSTEM
K092647 · OOE
Lensx Lasers, Inc.
Ophthalmic · 106d
Cleared Dec 04, 2009
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K091507 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 197d
Cleared Dec 03, 2009
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K093639 · HJO
Huvitz Co., Ltd.
Ophthalmic · 9d
Cleared Nov 25, 2009
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K090326 · HKI
Clarity Medical Systems
Ophthalmic · 289d
Cleared Nov 25, 2009
GDXPRO
K093521 · MYC
Carl Zeiss Meditec, Inc.
Ophthalmic · 12d
Cleared Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
K083757 · LYL
Bausch & Lomb, Inc.
Ophthalmic · 336d
Cleared Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 104d
Cleared Oct 27, 2009
NAVILAS LASER SYSTEM
K091064 · HQF
Od-Os GmbH
Ophthalmic · 196d
Cleared Oct 27, 2009
FLUID ISOLATION DEVICE
K091915 · HQC
Lenstec, Inc.
Ophthalmic · 119d