BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    Stethophone

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464055210·OTICON PLAY PX 2 MINIRITE R C079

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180188952·ELMED NATHANSON STYLE LIVER RETRACTORS, SIZE: S...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776413675·SMALL 6.5MM NATHANSON RETRACTOR, ROBOTIC SHAFT 9CM

    STERITEC EMU-GRAPH, MODEL NO. CI 131/US

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Elecsys Vitamin D total III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

    FDA Adverse Event
    Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

    DINAMAP PRO 100

    FDA Adverse Event
    Malfunction ·CRITIKON DE MEXICO·Product code DXN·November 10, 2014

    3.5MM 90? SERFAS ENERGY PROBE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·August 8, 2011

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·July 17, 2013

    BD SYRINGE 5ML LL EURO 125 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 5, 2024

    BD CONVENTIONAL SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 29, 2024

    Destino Twist 14F (also branded as Guidestar 14F)

    FDA Enforcement
    Class II ·Completed·Oscor Inc.·February 23, 2022

    TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

    FDA Enforcement
    Class II ·Ongoing·TAS Medical Inc·March 12, 2025

    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

    FDA Enforcement
    Class II ·Ongoing·LetsGetChecked Inc.·March 15, 2023

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021