7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BeautiBond Xtreme
FDA 510(k)
FDA Class 2
·Dental
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
reVive Light Therapy Essentials
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·October 28, 2008
AML SM STATURE 15.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 12, 2011
PINNACLE MTL INS NEUT44IDX66OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·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