BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    b-ONE Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BI-METRIC XR-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650718·

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAPIDVIT AND RAPIDWARM CLEAVE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023

    AGILIS¿ INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code DYB·May 22, 2019

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ANCURE ENDOGRAFT

    FDA Adverse Event
    Death ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·September 26, 2008

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    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