9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SAF FIXATIVE
FDA 510(k)
FDA Class 1
·Microbiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112736·3M™ Victory Series™ Second Molar Bands, 905-120...
KOAGULAB 60-S COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCENT DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 9, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 1, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024