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
3313–3336 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 11, 1992
SUNGLASSES (NON-PRESCRIPTION)
K920165 · HQY
Blair Corporation
Ophthalmic · 28d
Cleared Feb 07, 1992
LASER FLARE METER
K913852 · HJO
Kowa Optimed, Inc.
Ophthalmic · 164d
Cleared Feb 05, 1992
WETTING SOLUTION FOR HARD CONTACT LENSES
K914483 · LPN
Optopics Laboratories Corp.
Ophthalmic · 120d
Cleared Feb 05, 1992
IRRIGATOR/ASPIRATOR PROBE
K915074 · HMX
Biomedical Dynamics, Inc.
Ophthalmic · 89d
Cleared Jan 31, 1992
INSTRUMENT WIPE AND CORNEAL SHIELD
K912576 · HOY
Katena Products, Inc.
Ophthalmic · 233d
Cleared Jan 31, 1992
GOLDLENS(TM)
K913239 · HLZ
Doran Instruments, Inc.
Ophthalmic · 193d
Cleared Jan 30, 1992
DWYER EYE SYSTEMS ASPIRATION UNIT
K913261 · HQE
Spectracare, Inc.
Ophthalmic · 191d
Cleared Jan 27, 1992
CHIROFLEX II LENS MICROSERT(TM)
K914311 · HQL
Chiron Ophthalmics
Ophthalmic · 123d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314 · HKI
Candela Laser Corp.
Ophthalmic · 182d
Cleared Jan 23, 1992
GRIESHABER AIR/FLUID TUBING SET
K914587 · KYG
Grieshaber & Co.
Ophthalmic · 99d
Cleared Jan 23, 1992
FRIEDMANN ANALYSER 3
K914896 · HOK
Clement Clarke, Inc.
Ophthalmic · 84d
Cleared Jan 21, 1992
DOHLMAN DOANE KERATOPROTHESIS
K915062 · HQM
Mackeen Consultants, Ltd.
Ophthalmic · 74d
Cleared Jan 17, 1992
SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES
K914766 · HQY
Sun Sight Glasses Co., Ltd.
Ophthalmic · 87d
Cleared Jan 13, 1992
OPTI-LENS(TM) CONTACT LENS CASE
K915082 · LRX
Ryder Intl. Corp.
Ophthalmic · 62d
Cleared Jan 06, 1992
MOSSIMO OPTIC EYEWEAR
K912509 · HQY
Mossimo, Inc.
Ophthalmic · 214d
Cleared Jan 06, 1992
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
K914484 · HLI
Hgm Medical Laser Systems, Inc.
Ophthalmic · 90d
Cleared Dec 31, 1991
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
K914407 · HQY
Promedex, Inc.
Ophthalmic · 90d
Cleared Dec 31, 1991
SPECTACLE FRAMES
K914413 · HQZ
Mikado Ca.
Ophthalmic · 89d
Cleared Dec 31, 1991
PYRAMID SUNGLASSES/READING GLASSES
K914425 · HQY
Pyramid
Ophthalmic · 89d
Cleared Dec 30, 1991
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)
K912740 · HLQ
Visionary Systems, Inc.
Ophthalmic · 192d
Cleared Dec 30, 1991
FRAMES (SPECTACLES) VARIOUS TYPES
K914614 · HQZ
Match Optical Co.
Ophthalmic · 74d
Cleared Dec 27, 1991
PHACO TIP
K914229 · HQC
Tri-Star Ophthalmic
Ophthalmic · 98d
Cleared Dec 27, 1991
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
K915118 · HQC
Ipax, Inc.
Ophthalmic · 44d
Cleared Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384 · HQE
Nidek, Inc.
Ophthalmic · 210d