7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
MIDDLEBROOK 7H10 AGAR BASE-LOWPH
FDA 510(k)
FDA Class 2
·Microbiology
TAMPONADE BALLOON CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 25, 2014
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ILJ·January 2, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 2, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020