7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SECHRIST VOLUME VENTILATOR MODEL 2200B
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROTRAK EIA AUTOWASHER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012
1.5T SIEMENS ESPREE MRI
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code LNH·June 20, 2014
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