14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXCELSIOR XT-27 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LEFORTE NEURO SYSTEM BONE PLATE
FDA 510(k)
FDA Class 2
·Dental
PEACE OF MIND HOME DRUG TEST
FDA 510(k)
FDA Unclassified
·Unknown
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
STRATA 2 VALVE, REGULAR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·June 2, 2011
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 14, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 19, 2020
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025