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Baxter Edwards

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Devices
11

What Baxter Edwards makes

Baxter Edwards manufactures vascular access and cardiac devices, including externally supported EPTFE vascular grafts, percutaneous mechanical thrombectomy systems, coronary angioscopes, and central venous catheters. Their portfolio also covers cardiac catheterization tools like the Fogarty valvulotome and Swan-Ganz thermodilution catheters, as well as mitral and tricuspid valve repair rings with Duraflo treatment. Hemostasis valve introducers and side-branch occlusion systems for interventional procedures are also part of their offerings.

The company’s devices are regulated under FDA Class I and Class II classifications, with most products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Baxter Edwards have in the registry?

The registry currently lists 11 devices for Baxter Edwards. Devices recorded under merged duplicate company entries are counted once.

Which registries list Baxter Edwards's devices?

Among its 11 most recently registered devices, Baxter Edwards has devices listed in FDA 510(k) (11 devices).

What risk classes do Baxter Edwards's devices fall under?

Among its 11 most recently registered devices, the classes recorded for Baxter Edwards's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Baxter Edwards in the registry?

The most recently registered devices listed for Baxter Edwards include BAXTER HANDLE MODEL 1150, BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS, FOGARTY VALVULOTOME MODEL 700091 and BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD.

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