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
1873–1896 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 04, 1998
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · KYB
Staar Surgical Co.
Ophthalmic · 87d
Cleared Dec 02, 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · HNO
Barron Precision Instruments, LLC
Ophthalmic · 72d
Cleared Nov 25, 1998
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K983150 · LPN
Allergan, Inc.
Ophthalmic · 77d
Cleared Nov 25, 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT...
K983278 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 69d
Cleared Nov 25, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · MRC
Ciba Vision Corporation
Ophthalmic · 65d
Cleared Nov 18, 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 15d
Cleared Nov 17, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K982168 · LPN
Ciba Vision Corporation
Ophthalmic · 151d
Cleared Nov 13, 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES...
K983021 · LPL
Metrosoft, Inc.
Ophthalmic · 74d
Cleared Nov 06, 1998
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL...
K982110 · LPL
Optech, Inc.
Ophthalmic · 143d
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