BEUDAMED
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    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·August 27, 2014

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020

    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·March 22, 2017

    SYMPHONY

    FDA Adverse Event
    Malfunction ·SORIN CRM·Product code NVZ·August 26, 2015

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    FDA Enforcement
    Class II ·Terminated·G & H Wire Company·March 10, 2021

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·May 26, 2020

    EDWARDS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFE SCIENCES·Product code DYG·February 3, 2012

    *

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·June 26, 2012

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·July 21, 2025

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·July 21, 2025

    BLAZER PRIME XP TEMPERATURE ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OAD·March 30, 2026

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·September 14, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·May 14, 2018

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 17, 2014

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 28, 2020

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NKM·June 20, 2017

    G2 X FILTER SYSTEM - JUGULAR

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 7, 2022

    KORA

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code LWP·October 7, 2017

    ALARIS

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code FRN·March 16, 2020

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·February 8, 2007