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
1585–1608 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007,...
K011115 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 20d
Cleared Apr 27, 2001
HANSATOME MICROKERATOME
K010260 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Apr 27, 2001
MED-LOGICS DISPOSABLE ALK TUBING
K010353 · KYG
Med-Logics, Inc.
Ophthalmic · 80d
Cleared Apr 13, 2001
PRESCOTT'S SURGICAL SPEAR
K003842 · HOZ
Prescott'S, Inc.
Ophthalmic · 122d
Cleared Apr 12, 2001
VISTAKON (METHAFILCON A) CONTACT LENSES
K010507 · LPL
Vistakon
Ophthalmic · 50d
Cleared Apr 11, 2001
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR...
K010114 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 85d
Cleared Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · LPN
Ciba Vision Corporation
Ophthalmic · 152d
Cleared Mar 26, 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC)...
K010256 · LPL
Opti-Centre Laboratories
Ophthalmic · 56d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES...
K010636 · MVN
Ciba Vision Corporation
Ophthalmic · 18d