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Soma Access Systems, LLC

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Soma Access Systems, LLC makes

Soma Access Systems, LLC manufactures the EXACTTRACK Procedure Kit, a medical device designed for precise tracking and monitoring during surgical or procedural interventions.

The EXACTTRACK Procedure Kit is classified as a Class II device under FDA regulations and is 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.

Catalogue1

Newest first, rows 1-1 of 1

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 Soma Access Systems, LLC, initiated on 2014-03-24. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. 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.

  • 2014

    • 24 Mar 2014 Z-0215-2015 Class II Terminated There is a possibility the sterile packaging may fail before the expiration date specified on the package. Distribution: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ,…
      Full distribution text Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.
      Submission number: K113680

Frequently asked questions

How many devices does Soma Access Systems, LLC have in the registry?

The registry currently lists 1 device for Soma Access Systems, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Soma Access Systems, LLC's devices?

Among its 1 most recently registered device, Soma Access Systems, LLC has devices listed in FDA 510(k) (1 device).

What risk classes do Soma Access Systems, LLC's devices fall under?

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

Are there FDA recall records for Soma Access Systems, LLC?

FDA recall records list 1 recall initiated by Soma Access Systems, LLC, the most recent initiated on 24 Mar 2014. 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 Soma Access Systems, LLC in the registry?

The most recently registered devices listed for Soma Access Systems, LLC include SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT.

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