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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Stellar Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180159051·MALLEBALE TAPERED BLACK BLADE 1/4" X 3/4" WIDE,...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776191016·Tapered Retractor Blade

    VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ANN PH NAIL RT 10X220MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·January 26, 2026

    ANN BLUNT TIP SCREW 4X40MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·January 26, 2026

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 1, 2025

    GORE PROPATEN VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·November 21, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 10, 2011

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code HET·July 22, 2013

    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