7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
Tissue of Origin Test Kit-FFPE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTERSPEC APOGEE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NEK·February 18, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 1, 2014
PARADIGM INSULIN INFUSION PUMP MMT-512RNAS
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·January 20, 2011
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015