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
2425–2448 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 05, 1995
HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM...
K952261 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 51d
Cleared Jun 30, 1995
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
K952165 · HQD
Rand Scientific Corp.
Ophthalmic · 88d
Cleared Jun 26, 1995
OPTI PADS
K950940 · LYL
Karlen Mfg., Inc.
Ophthalmic · 119d
Cleared Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 105d
Cleared Jun 26, 1995
BOSTON CONTACT LENS CASE
K951552 · LRX
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Jun 26, 1995
SUNGLASSES
K951815 · HQY
Fung Won Optical Mfg. Co.
Ophthalmic · 91d
Cleared Jun 26, 1995
ROBERT B. SCOTT PLASTIC ARTIFICAL
K952538 · HQH
Robert B. Scott Ocularists of...
Ophthalmic · 26d
Cleared Jun 20, 1995
BOBES TONOMETER
K945446 · HKY
Bobes S.A.
Ophthalmic · 225d
Cleared Jun 15, 1995
NEITZ SLIT LAMP SL-H2
K951341 · HJO
Neitz Instruments Company, Ltd.
Ophthalmic · 83d
Cleared Jun 15, 1995
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
K951462 · HQC
Allergan Medical Optics
Ophthalmic · 77d
Cleared Jun 14, 1995
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
K950077 · MMQ
Par Vision Systems Corp.
Ophthalmic · 155d
Cleared Jun 14, 1995
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
K952259 · HQC
Storz Instrument Co.
Ophthalmic · 30d
Cleared Jun 08, 1995
FIBER HEAD LIGHT FH-300
K951337 · HPQ
Neitz Instruments Company, Ltd.
Ophthalmic · 76d
Cleared Jun 07, 1995
NON-MYDRIATIC RETINAL CAMERA
K941234 · HKI
Canon USA, Inc.
Ophthalmic · 449d
Cleared Jun 07, 1995
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · HJM
Peregrine Surgical , Ltd.
Ophthalmic · 120d
Cleared Jun 06, 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · HLI
Welch Allyn, Inc.
Ophthalmic · 81d
Cleared Jun 06, 1995
FAIRY WORLD INC
K951992 · HQY
Fairy World, Inc.
Ophthalmic · 39d
Cleared Jun 02, 1995
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · HQC
Storz Instrument Co.
Ophthalmic · 142d
Cleared Jun 02, 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · KYB
Chiron Vision Corp.
Ophthalmic · 72d
Cleared May 30, 1995
CUSTOM ARTIFICIAL HUMAN EYES
K945270 · HQH
Daniel T Acosta
Ophthalmic · 214d
Cleared May 30, 1995
DIGITAL RETINOSCOPIC PHOTOMETER
K951179 · HKO
Kudi Kalu, Inc.
Ophthalmic · 75d
Cleared May 26, 1995
SPECTACLE SUN GLASSES
K940324 · HQY
Occhiali, International Eyewear
Ophthalmic · 487d
Cleared May 26, 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · HQC
American Optical Corp.
Ophthalmic · 88d
Cleared May 24, 1995
SUNBLOCKER SUNGLASSES
K950807 · HQY
Blublocker Corp.
Ophthalmic · 91d