8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANTI-DISCONNECTION MECHANISM
FDA 510(k)
FDA Class 1
·Anesthesiology
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029047415·LL 2nd BI W/DISTAL HK
BEBIG ISOSEED I-125
FDA 510(k)
FDA Class 2
·Radiology
DECLIPSESPECT LAPAROSCOPY
FDA 510(k)
FDA Class 1
·Radiology
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 23, 2014
SYNCARDIA CARDIOWEST
FDA Adverse Event
Injury
·SYNCARDIA CARDIOWEST·Product code DSQ·January 29, 2013
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 21, 2010
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020