9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MODIFIED DPX BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
FORZA
FDA UDI
Orthofix US LLC·18257200077069·IMPACT CAP FOR 1/4 TURN
IDS SHBG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRE-FILLED CATHETER INFLATION SYRINGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 22, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021