BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    DYONICS CONTROL RF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KALORE™

    FDA UDI
    Gc America Inc.·14548161293068·KALORE™ Syringes (2 mL/4 g)AO2

    KALORE™

    FDA UDI
    Gc America Inc.·D0470035721·KALORE™ Syringes (2 mL/4 g)AO2

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019476·Jacobson Needle Holder

    E.N.S.I. SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEOLUS NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·January 16, 2025

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022

    PINNACLE MTL INS NEUT28IDX54OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTERNATIONAL·Product code KWA·March 14, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 23, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 25, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024