8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
INSULATION PAD
FDA 510(k)
FDA Class 1
·Cardiovascular
Arthrex®
FDA UDI
ARTHREX, INC.·00888867229365·2.7mm Insertion Handle, QC
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LCS COMPLETE POLY PATELLA STD
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·June 26, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 5, 2012
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
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