32 results
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20ms
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Sources: EU EUDAMED, US FDA
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
FDA 510(k)
FDA Class 2
·General Hospital
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·February 27, 2026
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
FDA 510(k)
FDA Class 2
·Orthopedic
STARBAND CRANIAL ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·December 30, 2025
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036536·STENT PED3-021-350-18 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036543·STENT PED3-021-350-20 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036499·STENT PED3-021-350-10 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036550·STENT PED3-021-350-25 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036505·STENT PED3-021-350-12 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036512·STENT PED3-021-350-14 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036529·STENT PED3-021-350-16 V03 VANTAGE
PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 30, 2025
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·December 30, 2025
PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 30, 2025
PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 9, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 8, 2026
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 15, 2019
PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 3, 2026
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code OUT·January 30, 2025