BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    UltraGuideCTR® image guided soft tissue release system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTROCAN SAFETY®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046964478611·INTROCAN SAFETY FEP 14G, 2.2X50MM-US

    INTROCAN SAFETY®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046963189068·Introcan Safety® IV Catheter 14 Ga. x 2 in., FE...

    Medical Surgical Masks-Non Sterile

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

    WILLCARE, MODEL GW-1020

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 1, 2024

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    UNKNOWN ASR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 18, 2011

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code HAB·July 25, 2013

    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

    FDA Enforcement
    Class II ·Ongoing·Braxton Medical Corporation·February 3, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014