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
1225–1248 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 11, 2006
RS-1000 ZOOM SLITLAMP WITH OPTION
K060869 · HJO
Rightmedical Products, LLC
Ophthalmic · 42d
Cleared May 09, 2006
ALPHASPHERE ORBITAL IMPLANT
K053298 · HPZ
Hydron Pty Limited
Ophthalmic · 165d
Cleared May 02, 2006
EAGLEVISION GELLANSERTS, MODEL REF 0040
K053333 · LZU
Eagle Vision, Inc.
Ophthalmic · 152d
Cleared Apr 14, 2006
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
K060533 · MSS
Lenstec, Inc.
Ophthalmic · 45d
Cleared Apr 07, 2006
THE AMO OPHTHALMIC SURGICAL SYSTEM
K060366 · HQC
Advanced Medical Optics, Inc.
Ophthalmic · 53d
Cleared Apr 06, 2006
TONOMETER DIATON
K060780 · HKX
Ryazan State Instruments
Ophthalmic · 15d
Cleared Mar 23, 2006
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K052891 · HNO
Hawken Industries
Ophthalmic · 161d
Cleared Mar 17, 2006
EYEPORT VISION TRAINING SYSTEM
K051684 · NXR
Exercise Your Eyes, Inc.
Ophthalmic · 267d
Cleared Mar 17, 2006
PANORAMIC, MODEL 200MA
K060424 · MYC
Optos Plc.
Ophthalmic · 28d
Cleared Mar 15, 2006
SURGISIS OCULAR GRAFT
K053622 · NXM
Iop, Inc.
Ophthalmic · 77d
Cleared Mar 15, 2006
SYNERGEYES PS HYBRID CONTACT LENS
K060102 · HQD
Synergeyes, Inc.
Ophthalmic · 61d
Cleared Mar 10, 2006
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR...
K051477 · LPL
Mi Gwang Contact Lens Co., Ltd.
Ophthalmic · 280d
Cleared Mar 03, 2006
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · HKY
Medtronic Xomed, Inc.
Ophthalmic · 84d
Cleared Mar 03, 2006
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
K053475 · HMR
Refractec, Inc.
Ophthalmic · 79d
Cleared Feb 10, 2006
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS...
K052983 · HQD
Paragon Vision Sciences
Ophthalmic · 109d
Cleared Jan 30, 2006
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON...
K053124 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 84d
Cleared Jan 30, 2006
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
K053176 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 77d
Cleared Jan 24, 2006
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K053044 · HKI
Opto Global, Inc.
Ophthalmic · 88d
Cleared Jan 19, 2006
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
K052651 · MSS
Rayner Surgical, Inc.
Ophthalmic · 115d
Cleared Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935 · MXK
Heidelberg Engineering
Ophthalmic · 86d
Cleared Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · HLJ
Precision Optics Corp.
Ophthalmic · 32d
Cleared Dec 15, 2005
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
K052606 · LPL
Marietta Vision
Ophthalmic · 84d
Cleared Dec 09, 2005
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
K050933 · NCR
Medisurg , Ltd.
Ophthalmic · 239d
Cleared Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · LPL
CooperVision, Inc.
Ophthalmic · 81d