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Xoft, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
6
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Xoft, Inc. makes

Xoft, Inc. manufactures electronic brachytherapy devices, including applicators for targeted radiation therapy. Their portfolio includes balloon applicators (e.g., the AXXENT BALLOON APPLICATOR), vaginal applicators, surface applicators, and specialized shielding devices like the FLEXISHIELD MINI. These products are designed for localized radiation treatment in clinical settings such as oncology.

The company’s devices fall under Class II regulatory classification in the US, requiring 510(k) clearance through the FDA. Their products are listed in the FDA’s 510(k) database, reflecting their authorization for commercial distribution. The manufacturer is based in the United States.

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

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Xoft, Inc., initiated on 2011-02-03. 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.

  • 2011

    • 3 Feb 2011 Z-1865-2011 Unclassified (pre-2012) Terminated Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy. Distribution: Nationwide Distribution including AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI. Submission number: K090417

Frequently asked questions

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

The registry currently lists 6 devices for Xoft, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Xoft, Inc.'s devices?

Among its 6 most recently registered devices, Xoft, Inc. has devices listed in FDA 510(k) (6 devices).

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

Among its 6 most recently registered devices, the classes recorded for Xoft, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Xoft, Inc.?

FDA recall records list 1 recall initiated by Xoft, Inc., the most recent initiated on 2011-02-03. 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 Xoft, Inc. in the registry?

The most recently registered devices listed for Xoft, Inc. include AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E, AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM, AXXENT VAGINAL APPLICATOR and AXXENT FLEXISHIELD MINI.

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