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
2473–2496 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 07, 1995
MENICON SP VIAL
K950878 · LRX
Hyman, Phelps & McNamara, P.C.
Ophthalmic · 38d
Cleared Apr 07, 1995
ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K951180 · LPL
Szabocsik and Assoc.
Ophthalmic · 22d
Cleared Apr 07, 1995
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
K951338 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 14d
Cleared Apr 04, 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · HLI
Welch Allyn, Inc.
Ophthalmic · 60d
Cleared Apr 04, 1995
SUNGLASSES
K951209 · HQY
Mainland Wholesale
Ophthalmic · 18d
Cleared Mar 28, 1995
SPECTACLE FRAME
K944313 · HQZ
Sun Hing Optical Manufactory , Ltd.
Ophthalmic · 211d
Cleared Mar 28, 1995
MULTIPLE
K950083 · HQY
Commonwealth Optical Manufactory , Ltd.
Ophthalmic · 77d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-1
K950789 · HKL
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3
K950791 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3A
K950792 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
SPOT RETINOSCOPE RX-3SP
K950793 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RC
K950794 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RP
K950795 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K950797 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 22, 1995
IVALON OPHTHALMIC SPONGE
K946016 · HOZ
Ivalon
Ophthalmic · 103d
Cleared Mar 22, 1995
CUSTOM OCULAR PROSTHESIS
K946226 · HQH
Frank Tanaka, Ocularist, Inc.
Ophthalmic · 90d
Cleared Mar 22, 1995
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · HQC
Storz Instrument Co.
Ophthalmic · 90d
Cleared Mar 22, 1995
STREAK RETINOSCOPE RX-2
K950790 · HKL
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Mar 22, 1995
HALOGEN DIAGNOSTIC SET BX A - 12345
K950796 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Mar 22, 1995
CHAMP INTERNATIONAL CORP.
K950922 · HQY
Champ International Corp.
Ophthalmic · 21d
Cleared Mar 22, 1995
XCEL SLIT LAMP
K951054 · HJO
Leica, Inc.
Ophthalmic · 15d
Cleared Mar 22, 1995
SUNGLASSES
K951080 · HQY
Taiwan Georgia Corp.
Ophthalmic · 13d
Cleared Mar 21, 1995
HORIZON 55 BI-CON TORIC
K950818 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 26d
Cleared Mar 14, 1995
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K944994 · HQC
Chiron Vision Corp.
Ophthalmic · 153d