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
1057–1080 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 07, 2009
KOWAGENESIS-DF
K091098 · HKI
Kowa Co. , Ltd.
Ophthalmic · 113d
Cleared Jul 28, 2009
NAVIJECT SUB2-1P, MODEL: LP604430
K092023 · MSS
Medicel AG
Ophthalmic · 22d
Cleared Jul 27, 2009
ACCUPEN
K083377 · HKX
Accutome Ultrasound, Inc.
Ophthalmic · 255d
Cleared Jul 09, 2009
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K082871 · MSS
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 283d
Cleared CT Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · LPN
Allergan, Inc.
Ophthalmic · 199d
Cleared Jul 02, 2009
KOWA VX-10 A
K091683 · HKI
Kowa Co. , Ltd.
Ophthalmic · 22d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115 · HKI
Topcon Corp.
Ophthalmic · 160d
Cleared Jun 16, 2009
STATIC VESSEL ANALYZER
K082196 · HKI
Imedos GmbH
Ophthalmic · 316d
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K082879 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
K082880 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K082883 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
SUPRA 577.Y LASER
K091581 · HQF
Quantel Medical
Ophthalmic · 14d
Cleared Jun 09, 2009
EPIPHANY INJECTION SYSTEM
K090161 · MSS
Staar Surgical Co.
Ophthalmic · 138d
Cleared Jun 04, 2009
FLOW CONTROLLER
K090938 · LZU
Odyssey Medical, Inc.
Ophthalmic · 62d
Cleared May 20, 2009
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K083921 · HQD
Synergeyes, Inc.
Ophthalmic · 140d
Cleared May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K090078 · NXM
Iop, Inc.
Ophthalmic · 116d
Cleared May 06, 2009
MATCHEDFLICKER
K090266 · NFJ
Eyeic Corporation
Ophthalmic · 92d
Cleared May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES,...
K083291 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 179d
Cleared Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · LPL
Ciba Vision Corporation
Ophthalmic · 165d
Cleared Mar 25, 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K081946 · HQF
Quantel Medical
Ophthalmic · 260d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Mar 23, 2009
HOYA IS INJECTOR SYSTEM
K081346 · MSS
Hoya Surgical Optics, Inc.
Ophthalmic · 313d
Cleared Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · HKI
Canon, Inc.
Ophthalmic · 30d
Cleared Mar 13, 2009
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K083316 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 123d