7 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Endocem MTA Premixed Regular
FDA 510(k)
FDA Class 2
·Dental
ASPIRE MAX ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ROCHE ACETAMINOPHEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GEI·October 22, 2008
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 16, 2011
UNKNOWN
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code DTB·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019