7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CREATININE-S ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DENSICOMP 250
FDA 510(k)
FDA Class 2
·Radiology
HEMODIAL CONCENTRATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MED DIV.·Product code FNL·December 4, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 15, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024