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    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00613994965882·SHUNT 24133-2 CSF-DELTA CHMBR PERIT 2.0

    NA

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169483934·SHUNT 24133-2 CSF-DELTA CHMBR PERIT 2.0

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 26, 2021

    JOEY CLAMP OPENING TOOL

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

    Captiva Spine SmartLOX Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIN LINER CONST NEUT 50ODX28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code KWZ·April 11, 2013

    UNKNOWN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 10, 2014

    CSE6L SMALLBORE EXTENSION SET

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code KGZ·September 2, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 26, 2024

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·February 18, 2025

    BELLATEK HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 18, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    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