7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
X-RAY GRID (RADIOLOGICAL GRID)
FDA 510(k)
FDA Class 1
·Radiology
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
FDA 510(k)
FDA Class 2
·Cardiovascular
CRANIOPLUG
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 24, 2015
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 19, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 29, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020