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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PROCTIGARD
FDA 510(k)
FDA Unclassified
·Unknown
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740774·Gray Forcep, 8-3/4" (22cm) serrated
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
QUANTA DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
OLM INTRACRANIAL PRESSURE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES·Product code GWM·August 28, 2008
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