7 results
·
56ms
·
Sources: EU EUDAMED, US FDA
VENTREZYME PHENOBARBITAL KIT IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
Valeo C Spacer System, Valeo II C IBF Device
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 1, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 22, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 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