8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Videa Caries Assist
FDA 510(k)
FDA Class 2
·Radiology
SUCTION LIPOLASTY ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 19, 2019
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 22, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 9, 2013
ZIMMER
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING·Product code HSX·February 18, 2008
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