7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VOLU-SOL NMB RETICULOCYTE STAIN
FDA 510(k)
FDA Class 1
·Hematology
COPRAN ZR/ORIGIN YZ
FDA 510(k)
FDA Class 2
·Dental
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
FDA 510(k)
FDA Class 2
·Radiology
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 16, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
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 Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018