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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
FDA Enforcement
Class II
·Terminated·Widex A/S·October 17, 2018
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·June 15, 2016