28 results
·
21ms
·
Sources: EU EUDAMED, US FDA
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176161499·2metal polisher lense CA 6p
0800,APS1,08,N,VL,LF,LO,RDL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828153072·0800,APS1,08,N,VL,LF,LO,RDL
ACUMED
FDA UDI
Acumed LLC·10806378042171·Calcaneal Plate Tray Lid Assembly
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BELLEGLASS HP TRANSLUCENT DENTIN
FDA 510(k)
FDA Class 2
·Dental
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 5, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 28, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 1, 2012
BIODESIGN TENSION-FREE URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·April 3, 2014
EXPRESS¿ VASCULAR SD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·October 22, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 27, 2015
INTERSTIM II
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 25, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 14, 2014
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Recall
Terminated
·St Jude Medical Inc.·Product code OSR·April 16, 2018
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Recall
Terminated
·St Jude Medical Inc.·Product code LWS·April 16, 2018
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 Recall
Terminated
·St Jude Medical Inc.·Product code NIK·April 16, 2018
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Recall
Terminated
·St Jude Medical Inc.·Product code NIK·April 16, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Recall
Terminated
·St Jude Medical Inc.·Product code NIK·April 16, 2018
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Recall
Terminated
·St Jude Medical Inc.·Product code NIK·April 16, 2018