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
3337–3360 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 24, 1991
LULMITEX NEONATAL TRANSILLUMINATOR
K912747 · HJN
Lumitex, Inc.
Ophthalmic · 186d
Cleared Dec 23, 1991
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · HLI
Carl Zeiss, Inc.
Ophthalmic · 194d
Cleared Dec 18, 1991
SOFTRANS INJECTOR
K913626 · HQL
Staar Surgical Co.
Ophthalmic · 125d
Cleared Dec 17, 1991
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
K912902 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 168d
Cleared Dec 16, 1991
TANDEM SCANNING MICROSCOPE
K912514 · HJO
Tandem Scanning Corp.
Ophthalmic · 193d
Cleared Dec 16, 1991
FRAMES (SPECTACLES)
K914239 · HQZ
Jane Fui Optical Co., Ltd.
Ophthalmic · 89d
Cleared Dec 09, 1991
POLLY'S CUTTER J-225
K914038 · HQE
O.R. Specialties, Inc.
Ophthalmic · 90d
Cleared Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
K914051 · HJK
Ocular Instruments, Inc.
Ophthalmic · 90d
Cleared Dec 04, 1991
DROLITE(TM) LIGHT SOURCE
K913273 · HJM
Vision Medical, Inc.
Ophthalmic · 134d
Cleared Dec 04, 1991
OPHTHALMIC STAND
K913961 · HMF
Luneau Ophtalmologie SA
Ophthalmic · 90d
Cleared Nov 27, 1991
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
K913929 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 85d
Cleared Nov 13, 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K914117 · HJK
Ocular Instruments, Inc.
Ophthalmic · 61d
Cleared Nov 13, 1991
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
K914529 · MOE
Oasis Medical, Inc.
Ophthalmic · 33d
Cleared Nov 07, 1991
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
K911734 · KYD
Northland Cataract & Eye Care Clinic
Ophthalmic · 204d
Cleared Nov 05, 1991
AUTOMATIC CORNEAL SHAPER
K913697 · HNO
Hansa Research & Development, Inc.
Ophthalmic · 78d
Cleared Nov 05, 1991
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
K913837 · HQE
Vision Medical, Inc.
Ophthalmic · 71d
Cleared Oct 25, 1991
SCOPTOPIC SENSITIVITY TEST-1[SST-1]
K914163 · HLX
Lkc Technologies, Inc.
Ophthalmic · 38d
Cleared Oct 25, 1991
KPE 230 AM
K914172 · HQC
Ipax, Inc.
Ophthalmic · 60d
Cleared Oct 25, 1991
KPE 220 TS, NONSTERILE
K914221 · HQE
Ipax, Inc.
Ophthalmic · 63d
Cleared Oct 23, 1991
PROFESSIONAL INDIRECT OPHTHALMOSCOPE
K912397 · HLI
Clement Clarke, Inc.
Ophthalmic · 148d
Cleared Oct 23, 1991
MULTI-VIEW BIFOCALS
K913081 · HPX
Camp Contact Lenses
Ophthalmic · 107d
Cleared Oct 23, 1991
ANOMALOSCOPE QUADRANT TEST-6
K913962 · HIW
Lkc Technologies, Inc.
Ophthalmic · 48d
Cleared Oct 21, 1991
LOOK VISCODISSECTOR
K913530 · HQC
Look, Inc.
Ophthalmic · 74d
Cleared Oct 21, 1991
DR. DEAN EDELL SOLARBLOC SUNGLASSES
K913640 · HQY
Cable Car Sunglasses
Ophthalmic · 68d