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
2113–2136 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 31, 1997
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
K964555 · MPA
Vitrotec, Inc.
Ophthalmic · 138d
Cleared Mar 31, 1997
ACRYPAK FOLDER
K965185 · KYB
Alcon Laboratories
Ophthalmic · 97d
Cleared Mar 31, 1997
ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY
K970268 · MSG
Alexander Mfg. Co.
Ophthalmic · 67d
Cleared Mar 31, 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377 · HNO
Plancon Instruments
Ophthalmic · 56d
Cleared Mar 31, 1997
STYLE EYES OPTICS
K970744 · HQY
Anti-Ray, Inc.
Ophthalmic · 31d
Cleared Mar 26, 1997
ORBSHOT KERATOMETER
K964891 · MMQ
Orbtek, Inc.
Ophthalmic · 110d
Cleared Mar 25, 1997
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · LPL
Menicon U.S.A., Inc.
Ophthalmic · 82d
Cleared Mar 25, 1997
HEDGES CORNEAL WETTING PAK
K970161 · KYG
Hedges Cwp, Inc.
Ophthalmic · 70d
Cleared Mar 25, 1997
VICTORY EYEWEAR CO
K970538 · HQY
Victory Eyewear Co., Ltd.
Ophthalmic · 41d
Cleared Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728 · HLI
Mira, Inc.
Ophthalmic · 706d
Cleared Mar 19, 1997
AARON VAC 2
K952558 · HKP
Aaron Medical Industries
Ophthalmic · 656d
Cleared Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
K965125 · HQY
California Design Studio, Inc.
Ophthalmic · 86d
Cleared Mar 19, 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · LPL
Biomed Devices Corp.
Ophthalmic · 29d
Cleared Mar 17, 1997
DGH MODEL 9000
K965127 · HQC
Dgh Technology, Inc.
Ophthalmic · 84d
Cleared Mar 11, 1997
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K963001 · LPL
Permeable Technologies, Inc.
Ophthalmic · 221d
Cleared Mar 11, 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 95d
Cleared Mar 11, 1997
LIFESTYLE BREAK THRU (POLYMACON)
K965012 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 85d
Cleared Mar 11, 1997
ROCCOBAROCCO & PRO-DYNAMIX
K965170 · HQY
Michelangelo, Inc.
Ophthalmic · 77d
Cleared Mar 07, 1997
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC)...
K964528 · LPL
Benz Research and Development Corp.
Ophthalmic · 115d
Cleared Mar 04, 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · HOZ
Shippert Medical Technologies Corp.
Ophthalmic · 90d
Cleared Mar 04, 1997
JAMES ALEX SUNGLASSES
K970101 · HQY
D&K Stores, Inc.
Ophthalmic · 50d
Cleared Mar 03, 1997
CANON TX-10 TONOMETER
K963079 · HKX
Canon USA, Inc.
Ophthalmic · 208d
Cleared Feb 26, 1997
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
K964018 · HQC
Michael Reynard, M.D.
Ophthalmic · 142d
Cleared Feb 25, 1997
SUNGLASSES (NON-PRESCRIPTION)
K964943 · HQY
Micron Eyewear Manufactory Co., Ltd.
Ophthalmic · 77d