8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUTEX HEADLIGHT SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867126091·HEADLESS COMPRES SCRW 4.3X80MM
PALL EC PLUS FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
BILE DIFFERENTIAL DISK
FDA 510(k)
FDA Class 1
·Microbiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 4, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 6, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020