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
1609–1632 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · LPL
Vistakon
Ophthalmic · 51d
Cleared Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K010223 · LPL
American Contact Lens, Inc.
Ophthalmic · 51d
Cleared Mar 12, 2001
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
K010082 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 61d
Cleared Mar 12, 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY...
K010126 · LPL
Cl-Tinters
Ophthalmic · 55d
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ
Nidek Co., Ltd.
Ophthalmic · 140d
Cleared Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594 · HMY
Moria, Inc.
Ophthalmic · 108d
Cleared Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · HNO
Oasis Medical, Inc.
Ophthalmic · 87d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826 · MVN
Ciba Vision Corporation
Ophthalmic · 87d
Cleared Mar 08, 2001
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT...
K003861 · LPL
Benz Research and Development Corp.
Ophthalmic · 85d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · MUW
Paragon Vision Sciences
Ophthalmic · 47d
Cleared Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
K002515 · HNO
Med-Logics, Inc.
Ophthalmic · 191d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · MML
Iop, Inc.
Ophthalmic · 87d
Cleared Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · LPN
Allergan, Inc.
Ophthalmic · 127d
Cleared Feb 21, 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K003789 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 75d
Cleared Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT...
K003996 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d