9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AUTO SUTURE SPINAL NERVE HOOK
FDA 510(k)
FDA Class 1
·Neurology
safeClinitubes D957P-70-45
FDA UDI
Radiometer Medical ApS·05700699429698·safeClinitubes D957P-70-45
ANI Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOLOC MTP PLATE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·July 27, 2015
4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·February 5, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code GIO·March 17, 2020
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·June 10, 2020