BEUDAMED
    12 results · 32ms · 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.

    NEWPORT E360 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843835·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE ...

    Neocis Guidance System

    FDA UDI
    NEOCIS INC·00810004900042·Anterior Fiducial Array, LRUL

    SIMPLICITY CLASSIC WING QD INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JEWEL CAST PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·April 11, 2013

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 28, 2008

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·April 13, 2011

    CERAMENT G

    FDA Adverse Event
    Malfunction ·BONEUSUPPORT AB·Product code QRR·December 10, 2025

    EPIDURAL CATHETERIZATION KIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAZ·July 12, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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