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Sonogage, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sonogage, Inc. makes

Sonogage, Inc. manufactures the CORNEO-GAGE TWO, a device designed for corneal topography and pachymetry measurements, enabling precise assessment of corneal thickness and curvature.

The CORNEO-GAGE TWO is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance process. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Corneo-Gage Two Ref K852862

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Sonogage, Inc., initiated on 2013-08-09. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2013

    • 9 Aug 2013 Z-2202-2013 Class II Terminated During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. Distribution: Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM,…
      Full distribution text Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.

Frequently asked questions

How many devices does Sonogage, Inc. have in the registry?

The registry currently lists 1 device for Sonogage, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sonogage, Inc.'s devices?

Among its 1 most recently registered device, Sonogage, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Sonogage, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Sonogage, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sonogage, Inc.?

FDA recall records list 1 recall initiated by Sonogage, Inc., the most recent initiated on 9 Aug 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sonogage, Inc. in the registry?

The most recently registered devices listed for Sonogage, Inc. include CORNEO-GAGE TWO.

Generated automatically from registry data and not verified by a human reviewer.