BEUDAMED
    22 results · 23ms · 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 ×

    SPINNING SPIROS, MODEL CH-2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025

    K-DEFIB/PACE, MODEL KDP-60A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CYNOSURE PHOTOGENICA VL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYMBIA T-SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

    ULTRA FAST-FIX ASSEMBLY - CURVED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·May 5, 2023

    ULTRA FAST-FIX ASSEMBLY - CURVED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·May 5, 2023

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

    E.COM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

    E.CAM

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

    ADVIA CENTAUR

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 29, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

    E.CAM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

    ULTRA FAST-FIX ASSEMBLY - CURVED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·May 5, 2023

    Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·April 7, 2006

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014