8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BIOJECT JET INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IPLAN
FDA 510(k)
FDA Class 2
·Neurology
7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·April 15, 2019
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·December 13, 2010
ENDURITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021