10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TREZ_HD
FDA 510(k)
FDA Class 2
·Neurology
SURSHIELD SAFETY WINGED INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
EASYLOCK OSTEOSYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016
RUSCH 100% SILICONE FOLEY 6 FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KOD·May 23, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
DIAMOND 3
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 20, 2026
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017