2 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
FDA Recall
Open, Classified
·LumiraDx·Product code KXG·April 25, 2023
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
FDA Recall
Open, Classified
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·March 8, 2023