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Ep Medsystems

Also registered as Ep Medsystems, Inc.

Country not established

Devices
15
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Ep Medsystems makes

Ep Medsystems manufactures electrophysiology catheters, including the Procath Electrophysiology Catheter and its modifications, along with the EP-4 Clinical Stimulator and EP-4TM Cardiac Stimulator models. They also produce the EP-Workmate system with RPM system, the ViewMate Ultrasound Imaging System, and the Procath Locking Peel-Away Introducer/Peel-Away Introducer Set.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) registry. Ep Medsystems is based in the US.

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

Catalogue15

Newest first, rows 1-15 of 15

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Rows 1-15 of 15

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 Ep Medsystems, initiated on 2006-04-04. 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.

  • 2006

    • 4 Apr 2006 Z-0914-06 Unclassified (pre-2012) Terminated Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system Distribution: Product was shipped to hospitals/users throughout the US. The firm has a Veterans Affair contract number V797P-4650A.…
      Full distribution text Product was shipped to hospitals/users throughout the US. The firm has a Veterans Affair contract number V797P-4650A. Also the firm has shipped the devices to Germany, United Kingdom, Netherlands, Italy, Japan, France, Saudi Arabia, Hong Kong, Syria, Malaysia, Sweden, Armenia, Australia, Canada, Iceland, S. Africa, and Taiwan.
      Submission numbers: K040207, K041442

Frequently asked questions

How many devices does Ep Medsystems have in the registry?

The registry currently lists 15 devices for Ep Medsystems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ep Medsystems's devices?

Among its 15 most recently registered devices, Ep Medsystems has devices listed in FDA 510(k) (15 devices).

What risk classes do Ep Medsystems's devices fall under?

Among its 15 most recently registered devices, the classes recorded for Ep Medsystems's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ep Medsystems?

FDA recall records list 1 recall initiated by Ep Medsystems, the most recent initiated on 2006-04-04. 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 Ep Medsystems in the registry?

The most recently registered devices listed for Ep Medsystems include PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER, EP-WORKMATE WITH RPM SYSTEM, EP-WORKMATE and MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER.

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