BEUDAMED
    46 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    FDA Recall
    Terminated ·Cepheid·Product code OPU·February 19, 2010

    Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    FDA Recall
    Terminated ·Cepheid·Product code OPU·February 19, 2010

    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·May 4, 2016

    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

    FDA Enforcement
    Class II ·Terminated·INO Therapeutics (dba Ikaria)·February 1, 2017

    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

    FDA Enforcement
    Class III ·Terminated·Impact Instrumentation, Inc.·August 15, 2012

    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 12, 2015

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Metal Catalog Number : 45-546

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Plastic Catalog Number: 45-559

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Plastic Catalog Number : 45-547

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Metal Catalog Number : 45-542

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/37/Plastic Catalog Number: 45-555

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters -Kit/CPU/15/37/Metal Catalog Number: 45-554

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Plastic Catalog Number: 45-557

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Metal Catalog Number : 45-552

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Plastic Catalog Number : 45-551

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Plastic Catalog Number : 45-549

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Metal Catalog Number : 45-550

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005