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
2689–2712 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 05, 1994
VISARD FRAMES
K942478 · HQZ
Iris Optical, Inc.
Ophthalmic · 72d
Cleared Aug 05, 1994
NOVALENS/NOVAWET PERCEPTION AND VANGUARD
K942533 · HQD
Ocutec Corporation, Inc.
Ophthalmic · 70d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
K942711 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
K942712 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
K942713 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
K942714 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
K942715 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
K942717 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K942719 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
K942720 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K942721 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
SUNGLASSES
K942754 · HQY
Kimball Corp.
Ophthalmic · 56d
Cleared Aug 05, 1994
OPTHALMIC WIPE
K942897 · HQZ
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 46d
Cleared Aug 05, 1994
SPECTACLE FRAMES
K943198 · HQZ
Lunettes Folomi S.A.
Ophthalmic · 31d
Cleared Aug 05, 1994
N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO
K943265 · HQZ
The First Optical Manufactory , Ltd.
Ophthalmic · 29d
Cleared Aug 05, 1994
SPOMA INTERNATIONAL CORPORATION
K943352 · HQY
Spoma Intl. Corp.
Ophthalmic · 24d
Cleared Aug 05, 1994
WINK EYEWEAR
K943507 · HQZ
Wink Optical, Inc.
Ophthalmic · 16d
Cleared Aug 04, 1994
SPECTACLE FRAMES, SUNGLASSES
K936125 · HQY
Eyedesigns Corp.
Ophthalmic · 224d
Cleared Aug 04, 1994
MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
K940088 · HQC
Medical Technical Products
Ophthalmic · 209d
Cleared Aug 04, 1994
SUNGLASSES
K940561 · HQY
Hibiscus Ind. Co. , Ltd.
Ophthalmic · 178d
Cleared Aug 04, 1994
SUNGLASSES
K941148 · HQY
Metal Dream S.R.L.
Ophthalmic · 147d
Cleared Aug 04, 1994
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · HLI
Keeler Instruments, Inc.
Ophthalmic · 94d
Cleared Aug 04, 1994
PERSOL, MOSCLHINO, AND GERALD GENTA
K942845 · HQZ
Persol America, Inc.
Ophthalmic · 49d
Cleared Aug 04, 1994
SPECTACLE FRAME
K943082 · HQZ
Daewon Optical Co.
Ophthalmic · 37d