8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioProtect Balloon Implant System
FDA 510(k)
FDA Class 2
·Radiology
CDC ZIRCONIA BLANKS
FDA 510(k)
FDA Class 2
·Dental
MICROFILL 13
FDA 510(k)
FDA Class 2
·Dental
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 10, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
3 ML BD LUER-LOK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·October 15, 2019
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018