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

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    Erchonia DPN Laser (Model# EVRL)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FETALGARD LITE-NIBP, MODEL FGL-NIBP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Slendertone connect Abs

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IMP,TSV,3.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 12, 2022

    IMP,TSV,3.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 6, 2024

    LONG SCALPEL HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GDZ·June 7, 2023

    IMP,TSV,3.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 12, 2022

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·December 8, 2008

    L/B KIT 1000ML TURNTAP

    FDA Adverse Event
    Injury ·COLOPLAST MANUFACTURING US LLC·Product code FAQ·September 16, 2011

    OPERA

    FDA Adverse Event
    Malfunction ·ARJO, MED AB LTD·Product code FSA·July 22, 2013

    LONG SCALPEL HANDLE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GDZ·January 21, 2021

    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    FDA Enforcement
    Class I ·Terminated·Sterilmed Inc·January 3, 2018