7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PHYSIOLOGICAL RECORDER MODEL 740
FDA 510(k)
FDA Class 1
·Cardiovascular
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Materialise Glenoid Positioning System
FDA 510(k)
FDA Class 2
·Orthopedic
SOFTCLIX LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 1, 2007
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 2, 2014
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·October 1, 2012
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025