BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    restor3d Kinos Axiom Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 19, 2024

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    CLINITEK STATUS+ ANALYZER

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS MFG., LTD.·Product code LCX·August 25, 2011

    BIG WHEEL STRETCHER, PRIME X

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

    BD ALARIS SMARTSITE TEXIUM SECONDARY SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·November 12, 2024

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    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