17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NEONATAL PHYSIOLOGICAL MONITOR 903
FDA 510(k)
FDA Class 2
·Cardiovascular
DECT Handset HAC
FDA UDI
Lifeline Systems Company·00884838081451·DTHS1000 Refurbished HAC
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916494970·Long-arm Multi-Axial Cannulated Screw, Ø10.5 x ...
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
FDA 510(k)
FDA Class 2
·Microbiology
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ACCU-CHEK ® COMPACT PLUS TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 30, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 12, 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