8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
DANAM ELEC. SA-1000
FDA 510(k)
FDA Class 2
·Hematology
VECTRIX EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A-38 CUP NON FLARED SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014
URISYS 1100
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code KHE·November 20, 2012
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 17, 2010
VERSYS FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER, TURPEAUX INDUSTRIAL PARK·Product code JDI·March 31, 2016
IMPELLA
FDA Adverse Event
Death
·ABIOMED, INC. - 1220648·Product code PYX·February 23, 2026