7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ALKALINE PHOSPHATASE ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICROALBUMIN MULTI-CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LessRay with Tracking
FDA 510(k)
FDA Class 2
·Radiology
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·June 1, 2014
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 22, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 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