7 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bevel Up Holder
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
CMAP PRO
FDA 510(k)
FDA Class 2
·Physical Medicine
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 13, 2008
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 22, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 27, 2013
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
FDA Enforcement
Class I
·Terminated·Quidel Corporation·July 7, 2021