7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DUPONT CRONEX PORTABLE GRID CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
CODMAN DURAFORM DURAL GRAFT IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
Nellcor Bedside Respiratory Patient Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 17, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 31, 2013
CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·December 29, 2010
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 3, 2015