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

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    InnoGenic Non-resorbable Membrane

    FDA 510(k)
    FDA Class 2 ·Dental

    BD ULTRA-FINE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 12, 2019

    Q-FLO CLOSED MALE LUER CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 22, 2008

    SYNCHRON LX20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·April 25, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 7, 2022

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025