7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
FDA 510(k)
FDA Class 2
·Anesthesiology
DIAMED MODELS 600, 900, 960, 964
FDA 510(k)
FDA Class 2
·Radiology
PLANMED SOPHIE
FDA 510(k)
FDA Class 2
·Radiology
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 11, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 24, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
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