7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PTH RIA 200
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LATERAL TRUNK SUPPORTS
FDA 510(k)
FDA Class 1
·Physical Medicine
Vantage Titan 3T, MRT-3010, V2.5
FDA 510(k)
FDA Class 2
·Radiology
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 10, 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