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
937–960 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 08, 2011
RTVUE CAM WITH CORNEAL POWER UPGRADE
K111505 · OBO
Optovue, Inc.
Ophthalmic · 100d
Cleared Aug 30, 2011
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
K110129 · HJO
Rightmedical Products, LLC
Ophthalmic · 224d
Cleared Aug 19, 2011
P200T
K111628 · MYC
Optos Plc.
Ophthalmic · 70d
Cleared Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
K111108 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 113d
Cleared Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY...
K110261 · LPL
Soflex Limited
Ophthalmic · 181d
Cleared Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · HQB
Nidek Co., Ltd.
Ophthalmic · 57d
Cleared Jul 14, 2011
CARA
K110869 · NFJ
Diagnos, Inc.
Ophthalmic · 107d
Cleared Jul 14, 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT...
K111856 · LRX
Apothecary Products, Inc.
Ophthalmic · 15d
Cleared Jul 08, 2011
RHA2020
K111531 · HLI
Annidis Health Systems Corp.
Ophthalmic · 36d
Cleared Jun 29, 2011
ASICO SOFTIP INJECTOR SYSTEM
K103495 · MSS
Asico, LLC
Ophthalmic · 212d
Cleared Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · LPL
CooperVision, Inc.
Ophthalmic · 167d
Not Cleared Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · ORZ
Tearscience, Inc.
Ophthalmic · 323d
Cleared Jun 23, 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412 · HKI
Eyequick.Llc
Ophthalmic · 303d
Cleared Jun 03, 2011
ISTAND
K103266 · HLI
Optovue, Inc.
Ophthalmic · 211d
Cleared Jun 01, 2011
UNIT, PHACOFRAGMENTATION
K103023 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 232d
Cleared May 23, 2011
SLIT LAMP SL-2G
K110489 · HJO
Topcon Medical Systems, Inc.
Ophthalmic · 90d
Cleared May 20, 2011
CLEARCUT S SAFETY KNIFE
K110166 · HNN
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
K110006 · NFJ
Ophthalmic Imaging Systems
Ophthalmic · 135d
Cleared May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986 · HKI
Optomed OY
Ophthalmic · 38d
Cleared May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
K110528 · FSR
Integra LifeSciences Corporation
Ophthalmic · 76d
Cleared May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · LPN
Alcon Research, Ltd.
Ophthalmic · 222d
Cleared Apr 28, 2011
ONE DAY FLAT PACK
K102895 · LPL
Menicon Co, Ltd.
Ophthalmic · 210d
Cleared Apr 26, 2011
NOVAKONE SPHERICAL AND TORIC LENSES
K102557 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 231d
Cleared Apr 20, 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859 · HKI
Clarity Medical Systems
Ophthalmic · 202d