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Greatbatch Ltd

Country not established

Devices
369

What Greatbatch Ltd makes

Greatbatch Ltd manufactures vascular catheter introduction sets, including peelable introducer kits designed for single-use procedures, as well as vascular guide-catheters for guiding medical instruments through blood vessels. Their portfolio also includes spinal cord stimulation systems for pain management, neurosurgical kits for non-medicated procedures, and electrical stimulation leads and adaptors for pacing, defibrillation, and neural-tissue applications. Epicardial pacing leads are among the company’s offerings for cardiac rhythm management.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class III, reflecting varying levels of risk and regulatory oversight. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

DUNS number
968623467
Phone
+1(727)937-2511

Frequently asked questions

How many devices does Greatbatch Ltd have in the registry?

The registry currently lists 369 devices for Greatbatch Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Greatbatch Ltd's devices?

Among its 50 most recently registered devices, Greatbatch Ltd has devices listed in FDA GUDID (50 devices).

What risk classes do Greatbatch Ltd's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Greatbatch Ltd's devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Greatbatch Ltd in the registry?

The most recently registered devices listed for Greatbatch Ltd include GORE GUIDRA Steerable Sheath GDSTS1205520, GORE GUIDRA Steerable Sheath GDSTS1206520, PTFE Peelable Introducer Kit 667127-303 and Algovita® 1126-75-USA.

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