11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707012245·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 28
IPS EMPRESS DIRECT FLOW
FDA 510(k)
FDA Class 2
·Dental
SPIROTEL
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·June 3, 2013
MAXI MOVE
FDA Adverse Event
Injury
·ARJO MED AB LTD·Product code FSA·September 3, 2014
RESIDENT BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 2, 2011
TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016