9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
artegral life
FDA UDI
Merz Dental GmbH·D7091993557·anteriors; shade BL1; mould IXL
ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTWAND-DTX
FDA 510(k)
FDA Class 1
·General Hospital
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 26, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·March 7, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·January 24, 2011
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024