BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Mini TENS Therapy Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    Bernafon

    FDA UDI
    Bernafon AG·05711584081587·ZERENA 9 B 105 FW 1.0

    SILVER CARE ANITBACTERIAL TOOTHBRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·July 8, 2011

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code NEW·October 24, 2024

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    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