7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
UPSHERSCOPE(TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
DELTA 32; DELTA 32 TACT
FDA 510(k)
FDA Class 2
·Radiology
ARTISAN EXTEND CONTROL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·January 15, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·July 9, 2014
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