BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Aventus Clot Management System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASSI

    FDA UDI
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645120056·Sistrunk Sciss. Cvd.,Standard,14cm

    ANTHRACIS REAL-TIME PCR ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRANS1 AXIAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    2.47 MM X 30.3 MM SPIRAL ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    TECNIS IOL

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·September 30, 2024

    DLT TS CER HD 12/14 32MM +9

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 6, 2023

    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

    FDA Enforcement
    Class II ·Ongoing·North American Rescue LLC.·October 8, 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