7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PVC Hydrophilic Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIVAL PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 7, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 6, 2012
TA PREMIUM 55 MEDIUM REUSABLE INSTRUMENT
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·August 27, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015