10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVO 700 series high speed handpiece
FDA 510(k)
FDA Class 1
·Dental
MINICAT DENTOCAT
FDA 510(k)
FDA Class 2
·Radiology
BARLE TISSUE ADHESIVE 2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
RAPID D INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·August 15, 2007
RAPID D INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·August 15, 2007
MDT-FIDELIS (6949)
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWS·November 14, 2008
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
PREMIUM SURGICLIP S-9.0 TITANIUM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code FZP·July 8, 2013
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024