8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GILLETTE HEAT WRAP
FDA 510(k)
FDA Class 2
·Physical Medicine
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
FDA 510(k)
FDA Class 2
·Orthopedic
DIALYZER (MODEL 1850)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA Adverse Event
Malfunction
·ACCURAY, INCORPORATED·Product code IYE·April 21, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 2, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025