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
2593–2616 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 22, 1994
TOMEY EM-1000 SPECULAR MICROSCOPE
K944910 · HJO
Tomey Corporation USA
Ophthalmic · 48d
Cleared Nov 22, 1994
AXIOM, SUNFAST
K944915 · HQY
Axiom Ent. Co., Ltd.
Ophthalmic · 47d
Cleared Nov 22, 1994
NON-PRESCRIPTION SUNGLASSES
K944996 · HQY
La Kinglong Intl., Inc.
Ophthalmic · 40d
Cleared Nov 22, 1994
BRIGHTEN
K945036 · HQY
New Daley Intl. Trading Co.
Ophthalmic · 40d
Cleared Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
K945122 · HQY
Aristar Inc. U.S.A.
Ophthalmic · 34d
Cleared Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
K945123 · HQZ
Aristar Inc. U.S.A.
Ophthalmic · 34d
Cleared Nov 22, 1994
RED DRAGON CORPORATION
K945249 · HQY
J C Intl., Inc.
Ophthalmic · 25d
Cleared Nov 22, 1994
SPECTACLE FRAME
K945323 · HQZ
M.Y. Vision Corp.
Ophthalmic · 21d
Cleared Nov 22, 1994
SPECTACLE FRAMES OR EYEGLASS FRAMES
K945340 · HQZ
Mi Mun Corp.
Ophthalmic · 21d
Cleared Nov 22, 1994
MAKROLON 2405 GOGGLES (LIGHT AND DARK)
K945346 · HOY
Universal Massage & Tanning, Inc.
Ophthalmic · 20d
Cleared Nov 22, 1994
FRAME, SPECTACLE
K945450 · HQZ
Kookje Apis Industrial Co.
Ophthalmic · 19d
Cleared Nov 17, 1994
LENSCHEK
K944022 · HLM
Leica, Inc.
Ophthalmic · 92d
Cleared Nov 15, 1994
OPTICAL FRAMES AND SUNGLASSES
K944526 · HQY
Aprilia Eyewear S.P.A.
Ophthalmic · 61d
Cleared Nov 15, 1994
SUNGLASSES AND SPECTACLE FRAMES
K944644 · HQY
Hung Wai Metal Manufactory
Ophthalmic · 55d
Cleared Nov 14, 1994
RETINA FLOWMETER
K943955 · HLI
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
RETINA TOMOGRAPH AND FLOWMETER
K943956 · HLI
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
RETINA ANGIOGRAPH
K944261 · HLI
Heidelberg Engineering
Ophthalmic · 74d
Cleared Nov 14, 1994
ROYAL PLASTIC SUNGLASSES
K944341 · HQY
Royal Plastic Sarl
Ophthalmic · 69d
Cleared Nov 14, 1994
NIL
K944641 · HQZ
Max-Vision (H.K.)Limited
Ophthalmic · 54d
Cleared Nov 10, 1994
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
K931072 · HJM
Hgm, Inc.
Ophthalmic · 618d
Cleared Nov 10, 1994
KODI OPTICAL CO., LTD. SUNGLASSES
K944484 · HQY
Kodi Optical Co. , Ltd.
Ophthalmic · 58d
Cleared Nov 10, 1994
SUNGLASSES
K945001 · HQY
Long Sheng Optical Co., Ltd.
Ophthalmic · 28d
Cleared Nov 08, 1994
MANDELKORN SUTURE LYSIS LENS
K933976 · HJK
Ocular Instruments, Inc.
Ophthalmic · 452d
Cleared Oct 31, 1994
RITCH NYLON SUTURE LASER LENS
K933264 · HJK
Ocular Instruments, Inc.
Ophthalmic · 482d