Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
2017–2040 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664 · MRH
Storz Instrument Co.
Ophthalmic · 86d
Cleared Oct 10, 1997
CBALK-1000 BLADE
K972727 · HNO
Howard Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 03, 1997
LASEREX LP1532 PHOTOCOAGULATOR
K972514 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 88d
Cleared Oct 03, 1997
EYE SPHERE, CONFORMERS
K972661 · HPZ
Gulden Ophthalmics
Ophthalmic · 79d
Cleared Oct 03, 1997
INNOVATOME MICROKERATOME
K973294 · HNO
Innovative Optics, Inc.
Ophthalmic · 31d
Cleared Oct 01, 1997
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
K972506 · HJM
Infinitech, Inc.
Ophthalmic · 90d
Cleared Sep 30, 1997
CATARACTSCREENER CT - S
K972440 · HKI
Neitz Instruments Company, Ltd.
Ophthalmic · 92d
Cleared Sep 30, 1997
ML-DISPOSABLE PAK
K972522 · MSR
Med-Logics, Inc.
Ophthalmic · 85d
Cleared Sep 30, 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · HOZ
Deroyal Industries, Inc.
Ophthalmic · 74d
Cleared Sep 30, 1997
SUNGLASSES (NON-PRESCRIPTION)
K973407 · HQY
Pacific Optical Co. , Ltd.
Ophthalmic · 21d
Cleared Sep 30, 1997
SUNGLASSES
K973490 · HQY
Tong Yang Optical Co.
Ophthalmic · 15d
Cleared Sep 19, 1997
DIGI-INJECTOR
K971067 · MRH
Medical Instrument Development...
Ophthalmic · 179d
Cleared Sep 17, 1997
SUNGLASSES
K972850 · HQY
Indoptica, S.A.
Ophthalmic · 47d
Cleared Sep 17, 1997
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
K973016 · HQY
Optimaxx Intl.
Ophthalmic · 35d
Cleared Sep 09, 1997
PUNCTUAL OCCLUDER
K972523 · LZU
Odyssey Medical, Inc.
Ophthalmic · 64d
Cleared Aug 26, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 8d
Cleared Aug 25, 1997
RUFF WORK EYEGEAR
K972717 · HQY
Ruff House, Inc.
Ophthalmic · 35d
Cleared Aug 22, 1997
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K972443 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 53d
Cleared Aug 20, 1997
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS
K972303 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 62d
Cleared Aug 14, 1997
CONFOSCAN
K971953 · HJO
Tomey Corporation USA
Ophthalmic · 78d
Cleared Aug 08, 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 38d
Cleared Aug 06, 1997
ENDOVIEW SPPHIRE LENS SET
K971853 · HJK
American Medical Devices, Inc.
Ophthalmic · 78d
Cleared Aug 01, 1997
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
K971950 · HQF
Infinitech, Inc.
Ophthalmic · 65d
Cleared Jul 31, 1997
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT...
K963512 · HQD
Benz Research and Development Corp.
Ophthalmic · 335d