8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ELITE 1500 RADIOGRAPHIC TILTING TABLE
FDA 510(k)
FDA Class 2
·Radiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867364356·Percutaneous Insertion Handle, 4.5mm
HERMITEX SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PREEMICARE MODEL 2500 TRANSPORT WARMER
FDA 510(k)
FDA Class 2
·General Hospital
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 26, 2014
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014