7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STOCKERT-SHILEY CAPS TIMER MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
ISPVAC TM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EndoWrist Suction Irrigator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLEO 90 INFUSION SET
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FPA·June 4, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 10, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022