7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CANNULA CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Dextramer CMV Kit
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
FDA 510(k)
FDA Unclassified
·Unknown
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·April 3, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 5, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 3, 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