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
2065–2088 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 26, 1997
SPECTACLE FRAMES (NON-PRESCRIPTION)
K972246 · HQY
Alimar Trading, Inc.
Ophthalmic · 10d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · MPA
Ophthalmic Technologies, Inc.
Ophthalmic · 49d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · MPA
American Medical Devices, Inc.
Ophthalmic · 106d
Cleared Jun 24, 1997
CEBE
K971644 · HQY
Suunto USA
Ophthalmic · 50d
Cleared Jun 24, 1997
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K971685 · HKI
Tomey Corporation USA
Ophthalmic · 48d
Cleared Jun 24, 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014 · HQY
Tamfort, Ltd.
Ophthalmic · 25d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194 · HQY
Riviera Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · MML
Ipax, Inc.
Ophthalmic · 78d
Cleared Jun 17, 1997
BLOOD FLOW ANALYZER
K970887 · HKY
Paradigm Medical Industries, Inc.
Ophthalmic · 98d
Cleared Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · HQC
Storz Instrument Co.
Ophthalmic · 60d
Cleared Jun 13, 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · HQY
W.J. Byrnes & Co. of Los Angeles, Inc.
Ophthalmic · 80d
Cleared Jun 13, 1997
AMO DIPLOMAX/OPSYS CONSOLE
K971186 · HQC
Allergan, Inc.
Ophthalmic · 73d
Cleared Jun 13, 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · HQY
Niko Sunglasses Corp.
Ophthalmic · 38d
Cleared Jun 13, 1997
OPTIM-EYES 450
K971875 · HQY
Taylor/Fox Enterprises, LLC
Ophthalmic · 24d
Cleared Jun 09, 1997
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005 · MPA
Synergetics, Inc.
Ophthalmic · 275d
Cleared Jun 09, 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · HQC
Visioncare Devices, Inc.
Ophthalmic · 77d
Cleared Jun 05, 1997
GLARE WARE
K970816 · HQY
Ergovision, Inc.
Ophthalmic · 91d
Cleared Jun 04, 1997
DUQIAO
K971551 · HQY
Duqiao Glasses (Group) Co. , Ltd.
Ophthalmic · 37d
Cleared May 29, 1997
PATHFINDER SUNGLASSES
K971495 · HQY
Coil
Ophthalmic · 35d
Cleared May 28, 1997
KASHA VISUAL FIELD SYSTEM
K971156 · HPT
Kasha Software, Inc.
Ophthalmic · 61d
Cleared May 22, 1997
ML DISPOSABLE ALK TUBING
K971173 · KYG
Med-Logics, Inc.
Ophthalmic · 52d
Cleared May 21, 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K971049 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 61d
Cleared May 21, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K971164 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 51d
Cleared May 20, 1997
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
K964702 · MMQ
Euclid Systems Corp.
Ophthalmic · 176d