8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRAUMA TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209120505·
Ligence Heart
FDA 510(k)
FDA Class 2
·Radiology
VIVAWAVE MICROWAVE ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·December 3, 2012
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010
EGIA ULTRA UNIVERSAL STAPLER
FDA Adverse Event
Injury
·COVIDIEN, USSC PUERTO RICO, INC.·Product code GDW·June 3, 2014
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