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
2017–2040 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Jul 31, 1997
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT...
K963744 · HQD
Benz Research and Development Corp.
Ophthalmic · 317d
Cleared Jul 31, 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC,...
K971832 · HOZ
M-Pact Worldwide Management Corp.
Ophthalmic · 73d
Cleared Jul 31, 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · HQY
Lbi U.S.A.
Ophthalmic · 20d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671 · HLI
Heidelberg Engineering
Ophthalmic · 83d
Cleared Jul 29, 1997
VISTA UNIVERSAL HANDPIECE
K972252 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
P3 UNIVERSAL PHACO HANDPIECE
K972253 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 25, 1997
D'ARC EYE CARE SUNGLASSES
K972490 · HQY
M & R Dist.
Ophthalmic · 23d
Cleared Jul 21, 1997
MOMO DESIGN OR MOMO
K972416 · HQY
Momo U.S.A., Inc.
Ophthalmic · 24d
Cleared Jul 15, 1997
CONFOCAL MICROSCOPE
K970414 · HJO
Con-S , Ltd.
Ophthalmic · 173d