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Endosound, Inc.

United StatesFDA applicant, unverified

Endosound, Inc. is a medical device manufacturer, with 20 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.

Devices
20

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 18
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 19
  • FDA Class I 1
Identifiers
  • DUNS 111281644

What Endosound, Inc. makes

Endosound, Inc. manufactures disposable ultrasound kits for endoscopic procedures, including reusable transducer modules and extension connectors for flexible endoscopic ultrasound imaging. Their portfolio also includes software for ultrasound imaging systems, mechanical leak testers for invasive medical devices, and endoscopic ultrasound-specific accessories like band applicators and adhesive bands. These products are designed to integrate with general-purpose ultrasound systems and enhance imaging during minimally invasive procedures.

The company’s devices are classified under FDA regulations as Class I and Class II, with some authorised through the 510(k) pathway and others listed under the Unique Device Identifier (UDI) system. Products are intended for use in the United States, where they comply with applicable medical device standards and reporting requirements. No additional regulatory bodies or international listings are referenced in the provided data.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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Company details

DUNS number
111281644
Phone
(971) 231-4791

Frequently asked questions

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

The registry currently lists 20 devices for Endosound, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Endosound, Inc.'s devices?

Among its 20 most recently registered devices, Endosound, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 20 most recently registered devices, the classes recorded for Endosound, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Endosound, Inc. include EndoSound® Biopsy Port Adapter 5054, EndoSound® Biopsy Port Adapter (5 pack) 5064, EndoSound® EVS Probe 5101 and EndoSound® EVS SideBeam 5103.

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