BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Anatase Navi Disposable Instrument

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Synthes GmbH·10886982167422·LOCKING CALCANEAL PLATE LONG-LEFT

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688049615·

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247546·No-Profile Interbody, 43mm x 30mm x 16mm, 25 Deg

    Cook

    FDA UDI
    COOK INCORPORATED·00827002537408·Multi-Injection Needle

    STERNALOCK® BLU SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036219529·

    POLYSYN SURGICAL SUTURE

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

    LTD POLYAXIAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

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

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·September 2, 2011

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·July 22, 2013

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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