8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EXETER BONE LAUAGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)
Optimus NEURO System - Sterile Kit
FDA 510(k)
FDA Class 2
·Neurology
INSPIRA HD, MODEL: NL1000
FDA 510(k)
FDA Class 2
·Radiology
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 5, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018