7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORFLO 300 PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·December 10, 2010
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 5, 2013
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 18, 2014
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015