10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Protective Face Mask for Medical Use
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QuickAligners
FDA 510(k)
FDA Class 2
·Dental
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 22, 2011
EONC
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025
BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024
ITREL 3
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·August 15, 2016
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022