13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
METALIT
FDA 510(k)
FDA Class 1
·Dental
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)
VITROS XT Chemistry Products TBIL-ALKP Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REGIONAL OXIMETER SYSTEM, MODEL 7600
FDA 510(k)
FDA Class 2
·Cardiovascular
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016
SIMULUS FLEXIBLE BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 5, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012
LAMITRODE TRIPOLE 16
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