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

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    Aevumed PHANTOM™-LP Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD

    FDA UDI
    Medos International Sàrl·10886705027835·PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braid...

    SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STER H TROC NAIL 380X9X130

    FDA Adverse Event
    Death ·DEPUT ACE S.A. 'R.L·Product code HSB·November 4, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 25, 2011

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 12, 2013

    BD KIESTRA IDENTIFA

    FDA Adverse Event
    Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

    BD KIESTRA¿ IDENTIFA

    FDA Adverse Event
    Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024

    BHR ACETABULAR CUP 52MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·December 8, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014