7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ENDAB ESTRIOL UNCONJUGATED
FDA 510(k)
FDA Class 1
·Clinical Chemistry
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
FDA 510(k)
FDA Class 2
·Orthopedic
HITACHI PRESTO
FDA 510(k)
FDA Class 2
·Radiology
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 30, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 20, 2012
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·September 15, 2010
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