8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPERATURE WELL PROBE, TWP SERIES
FDA 510(k)
FDA Class 2
·General Hospital
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
FDA 510(k)
FDA Class 2
·General Hospital
CINTEC PLUS CYTOLOGY
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code QKF·February 21, 2024
BLOWER MISTER WITH IV SETS
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GCJ·June 12, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 15, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 6, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015