8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PREDICTA ERYTHROPOIETIN KIT
FDA 510(k)
FDA Class 2
·Hematology
THE PEAK
FDA 510(k)
FDA Class 2
·Anesthesiology
XENON LIGHT SOURCE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·Product code FWM·September 16, 2021
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 16, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010
DIMENSION VISTA 1500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 10, 2014
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020