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Axion USA LLC

United Statesfrom the FDA registration address FDA establishment FEI 3027329006

Axion USA LLC is a medical device manufacturer, with 23 devices listed in EUDAMED and FDA GUDID (FDA Class II and I) as of 12 Nov 2026.

Devices
23
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • EUDAMED 23
  • FDA GUDID 23

A device listed in two registries counts in both.

Device classes
  • FDA Class II 14
  • FDA Class I 9
Identifiers
  • FDA FEI 3027329006

Catalogue23

Newest first, rows 1-23 of 23

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  • Axion 20139

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 327006

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 328008

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20114

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 20122

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 327010

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 327009

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 328006

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20035

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 327004

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20062

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 20027

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 328007

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20063

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 20140

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 20064

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 1023

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Axion 20015

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 327007

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20045

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 328010

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Axion 20222

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Axion 20127

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

Rows 1-23 of 23

Company details

FDA FEI number
3027329006
Address
120 Raskulinecz Rd, Carteret, NJ, 07008

Frequently asked questions

How many devices does AXION USA LLC have in the registry?

The registry currently lists 23 devices for AXION USA LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list AXION USA LLC's devices?

Among its 23 most recently registered devices, AXION USA LLC has devices listed in EUDAMED (23 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do AXION USA LLC's devices fall under?

Among its 23 most recently registered devices, the classes recorded for AXION USA LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from AXION USA LLC in the registry?

The most recently registered devices listed for AXION USA LLC include Axion 20139, Axion 327006, Axion 328008 and Axion 20114.

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

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.