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
1825–1848 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 02, 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
K990749 · HOZ
X-Tech Medical, LLC
Ophthalmic · 25d
Cleared Mar 31, 1999
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR...
K990264 · HQD
Metro Optics of Austin, Inc.
Ophthalmic · 63d
Cleared Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
K990075 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 78d
Cleared Mar 29, 1999
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
K983225 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 196d
Cleared Mar 29, 1999
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY...
K983496 · LPL
Opti-Centre Laboratories
Ophthalmic · 175d
Cleared Mar 26, 1999
DIGISCOPE OPHTHALMIC CAMERA
K990205 · HKI
Eye Tel Imaging, Inc.
Ophthalmic · 64d
Cleared Mar 25, 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · HKX
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Mar 15, 1999
TETRAFILCON A
K990606 · LPL
CooperVision, Inc.
Ophthalmic · 20d
Cleared Mar 05, 1999
ORBSCAN
K984443 · MXK
Technolas Perfect Vision GmbH
Ophthalmic · 81d
Cleared Mar 03, 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K983797 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 126d
Cleared Feb 18, 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
K983160 · LPL
Hydron , Ltd.
Ophthalmic · 162d
Cleared Feb 16, 1999
THE FREMSTAD RING
K982599 · HOZ
Ophthalmic Solutions, LLC
Ophthalmic · 204d
Cleared Feb 16, 1999
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K984143 · HQC
Fibra Sonics, Inc.
Ophthalmic · 90d
Cleared Feb 16, 1999
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
K984523 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 57d
Cleared Feb 11, 1999
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K983836 · MRC
Polymer Technology Div. Wilmington...
Ophthalmic · 104d
Cleared Feb 11, 1999
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · LPN
Lobob Laboratories, Inc.
Ophthalmic · 36d
Cleared Feb 03, 1999
EDI VERIS SYSTEM
K983983 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 86d
Cleared Feb 03, 1999
PANORAMIC200 OPTHALMOSCOPE
K983999 · HLI
Optos Plc.
Ophthalmic · 86d
Cleared Jan 29, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K982947 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 161d
Cleared Jan 26, 1999
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
K983912 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 84d
Cleared Jan 25, 1999
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
K984273 · MVN
Ciba Vision Corporation
Ophthalmic · 56d
Cleared Jan 21, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
K984046 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 70d
Cleared Jan 21, 1999
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K984259 · LPL
Cl-Tinters
Ophthalmic · 52d
Cleared Jan 20, 1999
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR...
K982997 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 146d