7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRATHIN/SP LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
ERYTHROPOIETIN EIA
FDA 510(k)
FDA Class 2
·Hematology
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·June 10, 2014
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2010
PLATE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·December 10, 2012
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