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Nanotherapeutics

Also registered as Nanotherapeutics, Inc.

Country not established

Devices
4
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Nanotherapeutics makes

Nanotherapeutics develops demineralized bone matrix (DBM) products, including NANOFUSE DBM and ORIGEN DBM with bioactive glass, designed for bone grafting and regenerative applications in orthopedic and spinal surgeries.

These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Nanofuse Dbm Ref K120279

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

  • Origen Dbm With Bioactive Glass, Nanofuse Dbm Ref K110976

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

  • Nanofuse Dbm Ref K142104

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

  • Origen Dbm With Bioactive Glass Ref K062459

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

FDA recalls2

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

FDA recall records list 2 recalls initiated by Nanotherapeutics, initiated on 2011-03-10. By recorded status: 2 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

    • 10 Mar 2011 Z-0346-2012 Unclassified (pre-2012) Terminated On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011 Distribution: Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA. Submission number: K110976
    • 10 Mar 2011 Z-0347-2012 Unclassified (pre-2012) Terminated On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011 Distribution: Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA. Submission number: K110976

Frequently asked questions

How many devices does Nanotherapeutics have in the registry?

The registry currently lists 4 devices for Nanotherapeutics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nanotherapeutics's devices?

Among its 4 most recently registered devices, Nanotherapeutics has devices listed in FDA 510(k) (4 devices).

What risk classes do Nanotherapeutics's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Nanotherapeutics's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Nanotherapeutics?

FDA recall records list 2 recalls initiated by Nanotherapeutics, the most recent initiated on 10 Mar 2011. 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 Nanotherapeutics in the registry?

The most recently registered devices listed for Nanotherapeutics include NANOFUSE DBM, ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM and ORIGEN DBM WITH BIOACTIVE GLASS.

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