9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEARFIL Universal Bond Quick 2
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Blank Paper Discs, 6mm diameter
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902310397·BD BBL™ Blank Paper Discs, 6mm diameter
BIT-Motion
FDA 510(k)
FDA Class 2
·Radiology
HepaFat-AI
FDA 510(k)
FDA Class 2
·Radiology
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·July 8, 2021
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 30, 2008
NEXGEN STEM EXTENSION, OFFSET
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·August 26, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 12, 2013
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021