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
1585–1608 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 13, 2001
OSMED TISSUE EXPANDER
K010852 · NFM
Iop, Inc.
Ophthalmic · 145d
Cleared Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
K010454 · HQD
Progressive Optical Research , Ltd.
Ophthalmic · 167d
Cleared Jul 27, 2001
HYDRO2, HS-75
K011914 · HQD
Innovision, Inc.
Ophthalmic · 38d
Cleared Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED...
K011718 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 51d
Cleared Jul 17, 2001
TORIC LITE LENS
K011256 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 84d
Cleared Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · MRC
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 67d
Cleared Jul 09, 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT...
K001962 · LPL
Bescon Co., Ltd.
Ophthalmic · 377d
Cleared Jul 09, 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS...
K002099 · LPL
Bescon Co., Ltd.
Ophthalmic · 363d
Cleared Jul 09, 2001
EASY CONTROL MICRO INSERTER, MODEL ON385
K011498 · NCE
Ophtec USA, Inc.
Ophthalmic · 55d
Cleared Jul 02, 2001
PROVIEW EYE PRESSURE MONITOR
K011199 · HKY
Bausch & Lomb, Inc.
Ophthalmic · 74d
Cleared Jul 02, 2001
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
K011740 · MML
Meddev Corp.
Ophthalmic · 27d
Cleared Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998 · HKX
Langham Ophthalmic Technologies
Ophthalmic · 85d
Cleared Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · HOZ
Medtronic Xomed, Inc.
Ophthalmic · 68d
Cleared Jun 26, 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011542 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 39d
Cleared Jun 22, 2001
ML BLADE, MODEL ML7030
K010872 · HNO
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
K010902 · HPZ
Porex Surgical, Inc.
Ophthalmic · 85d
Cleared Jun 19, 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND...
K011577 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 28d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011234 · LPL
American Biocurve, Inc.
Ophthalmic · 51d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011316 · LPL
American Contact Lens, Inc.
Ophthalmic · 44d
Cleared Jun 01, 2001
ISCREEN VISION SCREENER
K010315 · HKI
Iscreen, LLC
Ophthalmic · 119d
Cleared May 23, 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K004049 · LPL
Optech, Inc.
Ophthalmic · 145d
Cleared May 23, 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011089 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
K003442 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 179d
Cleared May 02, 2001
WEISS RETINAL CANNULA
K010305 · HMX
Micron Surgical, Inc.
Ophthalmic · 90d