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Ellman International, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Ellman International, Inc. makes

Ellman International, Inc. manufactures electrosurgical electrodes and handpieces, including noble alloy electrodes for precision tissue manipulation, the DISC-FX system for dermatological procedures, and the PelleFirm and PelleVe lines for non-invasive skin tightening and contouring. Their portfolio also includes the Surgitron 4.0 Dual RF S5-IEC device for radiofrequency-based surgical applications, designed for controlled tissue ablation or coagulation.

The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory compliance for commercial distribution in the United States. The manufacturer is based in the US.

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

Catalogue5

Newest first, rows 1-5 of 5

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 Ellman International, Inc., the earliest on 2012-05-04 and the most recent on 2016-09-07. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use 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.

  • 2016

    • 7 Sep 2016 Z-0748-2017 Class II Terminated Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02. Distribution: Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia,…
      Full distribution text Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.
      Submission number: K123366

  • 2012

    • 4 May 2012 Z-1624-2012 Not yet classified Terminated Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking. Distribution: Worldwide Distribution Submission number: K082834

Frequently asked questions

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

The registry currently lists 5 devices for Ellman International, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ellman International, Inc.'s devices?

Among its 5 most recently registered devices, Ellman International, Inc. has devices listed in FDA 510(k) (5 devices).

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

Among its 5 most recently registered devices, the classes recorded for Ellman International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ellman International, Inc.?

FDA recall records list 2 recalls initiated by Ellman International, Inc., the most recent initiated on 2016-09-07. 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 Ellman International, Inc. in the registry?

The most recently registered devices listed for Ellman International, Inc. include ELLMAN NOBLE ALLOY ELECTRODES, DISC-FX SYSTEM, PELLEFIRM and SURGITRON 4.0 DUAL RF S5-IEC.

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