7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ACUSON L538 TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ECHELON SPECTROSCOPY PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
Easyscreen
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 29, 2014
TRILOGY LONGEVITY POLY LINER
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·December 6, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 26, 2015
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020