2,309 results · 63ms · Sources: EU EUDAMED, US FDA

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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