7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ULTRAGATER WHEELCHAIR LIFT
FDA 510(k)
FDA Class 2
·Physical Medicine
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
FDA 510(k)
FDA Class 2
·Physical Medicine
KLS Martin LINOS Wrist System
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 18, 2013
FUSION OMNI-TOME SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 12, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 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