7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
FDA 510(k)
FDA Class 2
·Neurology
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 30, 2014
PINNACLE DESTINATION RENAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·November 20, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018