8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD PureHub Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197176200·Antrum Curette oval
30° an...
TRU LEGIONELLA
FDA 510(k)
FDA Class 2
·Microbiology
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
FDA 510(k)
FDA Class 2
·Dental
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·October 7, 2008
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 27, 2013
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018