7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BMLS03-3
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOSCAN FD MINI C-ARM
FDA 510(k)
FDA Class 2
·Radiology
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 14, 2010
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·January 29, 2013
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021