9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTILEAF INTENSITY MODULATING COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
ANS1 SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIDENT T ACETABULAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
METRX FLEX ARM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 3, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 9, 2010
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 17, 2014
HEARTSTART
FDA Adverse Event
Other
·LAERDAL MEDICAL A.S.·Product code LDD·June 14, 2006
HEARTSTART
FDA Adverse Event
Other
·LAERDAL MEDICAL, A.S.·Product code MKJ·June 23, 2006
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020