8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
METATECH ROBINSON BOLT ACCESSORY
FDA 510(k)
FDA Class 2
·Neurology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65888825521·Custom Pack
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
FDA 510(k)
FDA Class 3
·Cardiovascular
StatStrip Xpress Glucose Hospital Meter System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 19, 2014
EZ-PRO 2 AMBUL COT
FDA Adverse Event
Injury
·STRYKER CORP, MEDICAL DIV.·Product code FPO·October 21, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 20, 2012
Custom Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015