2,309 results
·
63ms
·
Sources: EU EUDAMED, US FDA
STAIN AWAY PLUS, 8.1 OZ
FDA Adverse Event
Malfunction
·REGENT LABS, INC.·Product code EFT·April 4, 2012
EPOC BGEM TEST CARD
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code KHP·August 14, 2013
EPOC BGEM TEST CARD
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code KHP·August 14, 2013
AU480 WITH ISE CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JLB·November 27, 2010
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·May 17, 2019
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·March 31, 2019
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·September 4, 2019
SAFESHEATH® II
FDA Adverse Event
Malfunction
·OSCOR INC·Product code DYB·July 23, 2025
VITROS CHEMISTRY PRODUCT VALP REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·March 12, 2008
THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·April 23, 2021
THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·June 4, 2020
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·June 23, 2023
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·August 9, 2023
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·March 4, 2020
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·October 6, 2022
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·February 14, 2019
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·June 25, 2019
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·August 6, 2019
THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·April 29, 2021