8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EMIT GENTAMICIN CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517672360·CoRoent® SI Trial, 10x19x16mm 7°
TDM Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 5, 2014
SENSIA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 15, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 22, 2015
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