7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
IVAC PC ANIFUSER
FDA 510(k)
FDA Class 2
·General Hospital
DAHLBERG MODEL LU BTE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
FDA 510(k)
FDA Class 2
·Orthopedic
PARACORPOREAL VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 15, 2015
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 17, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 7, 2012
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