BEUDAMED
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    ARMADA 35/35LL PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584005989·CT5 N, PS SF MAC CANTEO 5

    PF 5050 PRESSURE UNIT, MODEL PF 5050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 23, 2025

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 21, 2024

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 21, 2024

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 23, 2024

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 1, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2013

    CONSERVE A-CLASS

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL·Product code KWY·May 29, 2011

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·August 12, 2008

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·June 16, 2022

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 9, 2025

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 27, 2024

    IMP,TSV,MCOL MG,4.7MM,13M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 20, 2023

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·February 13, 2019

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021