7 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Completed
×
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Recall
Completed
·IMMUNDIAGNOSTIK, Inc·Product code DEG·March 27, 2023
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Enforcement
Class II
·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
FDA Recall
Completed
·Boston Scientific Corporation·Product code DQK·September 18, 2019
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Recall
Completed
·Invivo Corporation·Product code DQK·September 24, 2018
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
FDA Recall
Completed
·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 13, 2017
CardioTek EP-TRACER Software V2.x.
FDA Recall
Completed
·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 25, 2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
FDA Recall
Completed
·GE Healthcare, LLC·Product code DQK·March 16, 2022