7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NEW JERSEY FEMORAL RESURFACING COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
zenostar MO, Zenostar T, Zenostar VisualiZr
FDA 510(k)
FDA Class 2
·Dental
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·June 1, 2014
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 22, 2012
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 27, 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