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
1657–1680 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 31, 2000
RIGID GAS PERMEABLE CONTACT LENS
K002025 · HQD
Polymer Technology
Ophthalmic · 120d
Cleared Oct 31, 2000
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · MSS
Pharmacia & Upjohn Co.
Ophthalmic · 75d
Cleared Oct 23, 2000
THERMAL CAUTERY UNIT, MODEL 150
K002341 · HQO
Geiger Medical Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 23, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · LPN
Alcon Universal, Ltd.
Ophthalmic · 63d
Cleared Oct 20, 2000
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
K002547 · HQP
Starion Instruments
Ophthalmic · 64d
Cleared Oct 20, 2000
VISIJET HYDROKERATOME, MODEL 50
K991124 · MYD
Visijet, Inc.
Ophthalmic · 567d
Cleared Oct 20, 2000
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
K994320 · NCZ
Cantor & Silver , Ltd.
Ophthalmic · 303d
Cleared Oct 18, 2000
SMARTLENS
K002510 · HKX
Odc Ophthalmic Development Co. AG
Ophthalmic · 64d
Cleared Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB...
K002849 · HNO
Surgical Specialties Corp
Ophthalmic · 35d
Cleared Oct 17, 2000
INSIGHT 4000 ENDOSCOPE
K000252 · MPA
Insight Instruments Mfg., Inc.
Ophthalmic · 264d
Cleared Oct 17, 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · LPL
Unilens Corp., USA
Ophthalmic · 71d
Cleared Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 36d
Cleared Oct 12, 2000
CARRIAZO BARRAQUER II MICROKERATOME
K002191 · HMY
Moria, Inc.
Ophthalmic · 84d
Cleared Oct 10, 2000
MENICON PROGENT REMOVER
K002140 · MRC
Menicon Co, Ltd.
Ophthalmic · 85d
Cleared Oct 04, 2000
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
K001125 · NCE
Geuder GmbH
Ophthalmic · 180d
Cleared Oct 02, 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464 · HNO
Oasis
Ophthalmic · 145d
Cleared Sep 25, 2000
LIPIDURE REWETTING DROPS
K000975 · MRC
Nof Corp.
Ophthalmic · 182d
Cleared Sep 21, 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176 · HNO
Oasis Medical, Inc.
Ophthalmic · 163d
Cleared Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
K994340 · HLI
Hai Laboratories, Inc.
Ophthalmic · 272d
Cleared Sep 19, 2000
OCCU-FLO PUNCTUM PLUGS
K001768 · LZU
U.S. Iol, Inc.
Ophthalmic · 99d
Cleared Sep 13, 2000
METHAFILCON A
K002625 · LPL
CooperVision, Inc.
Ophthalmic · 21d
Cleared Sep 13, 2000
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
K002647 · LPL
Marietta Contact Lens Service
Ophthalmic · 20d
Cleared Sep 12, 2000
REFRACTIVE SURGERY BLADES
K001806 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 89d
Cleared Sep 12, 2000
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K002044 · HLJ
Magna Fortis Corporation
Ophthalmic · 69d