37 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HOT/ICE DUAL FUNCTION EQUIPMENT
FDA 510(k)
FDA Class 2
·Physical Medicine
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
FDA 510(k)
FDA Class 2
·Neurology
Klassic HD® Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMON BILIARY STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 25, 2018
ZIMMON BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 14, 2018
ZIMMON BILIARY STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 9, 2019
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 22, 2021
ZIMMON BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 11, 2018
OASIS ONE ACTION STENT INTRODUCTION SYSTEM
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 11, 2018
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 4, 2020
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 4, 2020
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 4, 2020
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 4, 2020
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 4, 2020
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 16, 2018
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 13, 2014
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 16, 2010
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·December 11, 2012
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 18, 2018
COTTON-LEUNG BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 16, 2018