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
1441–1464 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 02, 2003
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH...
K030167 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 76d
Cleared Apr 01, 2003
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT
K030027 · LPL
Gelflex Laboratories
Ophthalmic · 88d
Cleared Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
K030350 · KYF
Optonol, Ltd.
Ophthalmic · 38d
Cleared Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · MRC
Ciba Vision Corporation
Ophthalmic · 136d
Cleared Feb 26, 2003
SCLERAL PLUGS, 19 AND 20 GAUGE
K022186 · LXP
Microvision, Inc.
Ophthalmic · 236d
Cleared Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023987 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023989 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · HJK
Fci Ophthalmics, Inc.
Ophthalmic · 51d
Cleared Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
K023643 · MTZ
Macropore Biosurgery, Inc.
Ophthalmic · 114d
Cleared Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · HKY
Luneau SA
Ophthalmic · 94d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Contamac, Ltd.
Ophthalmic · 70d
Cleared Feb 12, 2003
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A)...
K024164 · HQD
Metro Optics, Inc.
Ophthalmic · 57d
Cleared Feb 05, 2003
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT...
K024003 · LPL
Gelflex
Ophthalmic · 63d
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750 · MML
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
K030179 · NKX
Surgical Instruments Service and...
Ophthalmic · 7d
Cleared Jan 22, 2003
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K024177 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 35d
Cleared Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT...
K023791 · LPL
Softfocal Company, Inc.
Ophthalmic · 58d
Cleared Jan 08, 2003
MICROVISION SCLERAL BUCKLING COMPONENTS
K023481 · HQX
Microvision, Inc.
Ophthalmic · 83d
Cleared Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723 · KYB
Mastel Precision, Inc.
Ophthalmic · 132d
Cleared Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K023349 · LPL
Contamac, Ltd.
Ophthalmic · 78d
Cleared Dec 23, 2002
MP-1 MICRO PERIMETER
K023719 · HKI
Nidek Technologies Srl
Ophthalmic · 48d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · HQF
Quantel Medical
Ophthalmic · 90d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482 · HNO
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
K021699 · LYL
Autolens, Inc.
Ophthalmic · 208d