8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TRIGLYCERIDES REAGENT (PRODUCT #88218)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
AST(SGOT) IN VITRO DIAG. REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZIMMER GREAT TOE
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·June 19, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 1, 2015
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·December 21, 2012
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025