9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IMPERIUM
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480108000·Camera Head 4K UHD Zoom
NA
FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480113615·Camera Head 4K UHD Zoom
OHMEDA OXYGEN BLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
PrimeSight UltraView System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUMAX 740 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code MRM·February 5, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·December 15, 2010
ACCENT DR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 23, 2014
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