8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
FDA 510(k)
FDA Class 1
·Physical Medicine
CALCIGEN-S BONE VOID FILER
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE VINYL EXAM GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
TAPERLOC 133 TYPE1 PPS HO 11.0
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 2, 2015
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 22, 2008
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 17, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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