8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
L.C.S. 2000 SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEXINGTON MEM W COLUMBIA SC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·October 30, 2013
ROCHE REAGENT FOR TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AVI MICRO 210D INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NIQ·December 3, 2010
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·January 14, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 3, 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