8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
THOMPSON TYPE HIP PROTHESIS
FDA 510(k)
FDA Class 3
·Orthopedic
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
PRIMAGARD SURGICAL EQUIPMENT DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BABY BLUE RESUS BAG
FDA Adverse Event
Malfunction
·CAREFUSION/VITAL SIGNS·Product code BTM·June 24, 2014
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 18, 2013
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DSI·December 13, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015