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
4657–4680 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 19, 1983
CATAREX DIAP. EXTRACAPSULAR CATARACT
K832446 · HQE
Calliope Corp.
Ophthalmic · 86d
Cleared Oct 19, 1983
OCUTOME PARATUBING SET
K832938
Vxtra Corp.
Ophthalmic · 47d
Cleared Oct 19, 1983
SCIENTRONICS 10K EYE MAGNET
K832950 · HPO
Scientific Manufacturer
Ophthalmic · 49d
Cleared Oct 19, 1983
VXTRA OCUTOME KIT
K832980 · HQC
Vxtra Corp.
Ophthalmic · 47d
Cleared Oct 04, 1983
SIAS IRRIGATION/ASPIRATION SYSTEM
K832413 · HQC
Clark Pool & Assoc.
Ophthalmic · 75d
Cleared Oct 04, 1983
SENSITIVE EYES
K832706 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Oct 04, 1983
ELECATH HEPARIN COATED THERMAL DILUTION
K832787 · KYG
Electro-Catheter Corp.
Ophthalmic · 49d
Cleared Oct 04, 1983
I-GLIDE IOL IMPLANTATION AID
K832939 · KYB
I For M, Inc.
Ophthalmic · 35d
Cleared Oct 04, 1983
EPA AUTOMATED INFUSION POLE
K832997 · HQC
Miami Eye Technology, Inc.
Ophthalmic · 32d
Cleared Sep 29, 1983
DISPOSABLE VITRECTOMY HANDPIECE
K832235 · HQE
Innovative Surgical Products, Inc.
Ophthalmic · 80d
Cleared Sep 29, 1983
OCUCARE FREEDOM PACK
K832559 · HQC
Ocular Innovations, Inc.
Ophthalmic · 59d
Cleared Sep 29, 1983
MILLER/NADLER GLARE TESTER
K832762 · HLX
Titmus Optical, Inc.
Ophthalmic · 44d
Cleared Sep 29, 1983
AUTOMATIC TANGENT SCREEN 50
K832800 · HOO
CooperVision, Inc.
Ophthalmic · 42d
Cleared Sep 29, 1983
HARD CONTACT LENS CLEANER
K832810 · HPX
Blairex Laboratories, Inc.
Ophthalmic · 42d
Cleared Sep 29, 1983
RUBY KNIVES FOR OPHTH. SURGERY
K832844 · HNN
Keeler Instruments, Inc.
Ophthalmic · 38d
Cleared Sep 29, 1983
ABBOTT GLOBE HOLDER
K832911 · HJO
Miami Eye Technology, Inc.
Ophthalmic · 31d
Cleared Sep 20, 1983
SCLERAL BUCKLING IMPLANTS DIF/TYPES
K832481 · HQX
Storz Instrument Co.
Ophthalmic · 56d
Cleared Sep 12, 1983
ENVISION G21 I/A ENPAK
K832423 · HQC
Envision, Inc.
Ophthalmic · 52d
Cleared Sep 12, 1983
ENVISION G31 P.E. PAK
K832424 · HQC
Envision, Inc.
Ophthalmic · 52d
Cleared Sep 12, 1983
DISCO SUNGLASSES/HEADBAND SUNGLASSES
K832564 · HQY
E-Tay Industrial Co. , Ltd.
Ophthalmic · 41d
Cleared Aug 31, 1983
LEADING EDGE OPHTHALMIC KNIFE
K831975 · HNN
Surgidev Corp.
Ophthalmic · 72d
Cleared Aug 16, 1983
MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
K831773 · HQJ
Bcd Products, Inc.
Ophthalmic · 75d
Cleared Aug 16, 1983
LENSOMETER
K832085
CooperVision, Inc.
Ophthalmic · 49d
Cleared Aug 16, 1983
DIGILAB 350 THE KRAKAU PERIMETER
K832175 · HPT
Bio-Rad
Ophthalmic · 41d