5 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Posey Connected Twice-As-Tough Cuffs
FDA Recall
Terminated
·TIDI PRODUCTS·Product code FMQ·April 12, 2019
Posey Connected Twice-As-Tough Cuffs
FDA Enforcement
Class II
·Terminated·TIDI PRODUCTS·November 6, 2019
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
FDA Recall
Terminated
·Contour Fabricators Inc·Product code EAJ·September 9, 2016
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 Recall
Terminated
·Widex A/S Nymollevej 6 Lynge Denmark·Product code ESD·August 31, 2018
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 3, 2019