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

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    Oligio X

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR72403131·High-Tech-Brackets Ricketts 'N' .018" f. weld. ...

    ABL800 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·March 25, 2024

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR72403130101·High-Tech-Brackets Ricketts 'N' .018" f. weld. ...

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR72403131001·High-Tech-Brackets Ricketts 'N' .018" f. weld. ...

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR72403130051·High-Tech-Brackets Ricketts 'N' .018" f. weld. ...

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021206·FM5 - Alice 6

    TITUS MEDICAL (UTERINE MANIPULATOR INJECTOR)

    FDA Adverse Event
    Malfunction ·TITUS MEDICAL LLC·Product code LKF·June 6, 2025

    STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    HRV TOOLS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 20, 2020

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 9, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 10, 2014

    1.85MM X 16MM FLUTED ROUTER

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

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·June 14, 2021

    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

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

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

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

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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