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
1873–1896 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 06, 1998
OCU-GUARD AND OCU-GUARD SUPPLE
K983581 · HQX
Bio-Vascular, Inc.
Ophthalmic · 24d
Cleared Nov 03, 1998
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Oct 23, 1998
WINSTATION RETINAL IMAGER
K982689 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 81d
Cleared Oct 21, 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS...
K983053 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 50d
Cleared Sep 18, 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K980816 · HQX
Fci Ophthalmics, Inc.
Ophthalmic · 199d
Cleared Sep 11, 1998
FOAM TIP INJECTOR
K980696 · MSS
Staar Surgical Co.
Ophthalmic · 200d
Cleared Sep 02, 1998
SOFT (HYDROPHILIC) CONTACT LENSES
K982774 · LPL
Cl-Tinters
Ophthalmic · 26d
Cleared Sep 01, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND...
K981168 · LPN
Allergan, Inc.
Ophthalmic · 153d
Cleared Sep 01, 1998
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K982904 · LPL
Les Laboratoires Blanchard
Ophthalmic · 14d
Cleared Aug 25, 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742 · HNO
Moria, Inc.
Ophthalmic · 99d
Cleared Aug 25, 1998
THE WAVE DIGITAL PHACO SYSTEM
K981989 · HQC
Circuit Tree
Ophthalmic · 81d
Cleared Aug 14, 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535 · HKI
Marcher Enterprises, Ltd.
Ophthalmic · 255d
Cleared Aug 14, 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · HNO
Hawken Industries
Ophthalmic · 136d
Cleared Aug 14, 1998
BC 900 SLIT LAMP
K982057 · HJO
Haag-Streit AG
Ophthalmic · 64d
Cleared Aug 05, 1998
S2LO
K981640 · HLI
Odyssey Optical Systems, LLC
Ophthalmic · 89d
Cleared Aug 04, 1998
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
K980197 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 196d
Cleared Aug 04, 1998
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
K981907 · MRH
Peregrine Surgical , Ltd.
Ophthalmic · 64d
Cleared Jul 24, 1998
LIQUID ENZYME ID 90133
K981561 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jul 24, 1998
CARRIAZO BARRAQUER MICROKERATOME
K981741 · HMY
Moria, Inc.
Ophthalmic · 67d
Cleared Jul 23, 1998
ML MICROKERATOME
K981071 · HNO
Med-Logics, Inc.
Ophthalmic · 121d
Cleared Jul 22, 1998
REFRACTEC MCS-100
K980522 · HQR
Refractec, Inc.
Ophthalmic · 162d
Cleared Jul 15, 1998
OCULOSTAT
K981235 · HNC
Laser Center Dev. Corp.
Ophthalmic · 103d
Cleared Jul 09, 1998
TITANIUM PEG SYSTEM
K980822 · MQU
Fci Ophthalmics, Inc.
Ophthalmic · 128d
Cleared Jul 09, 1998
SURGIN KIT
K980849 · MSR
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 154d