BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    0.014” Willow Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295129363·12/14 ARTICULEZE TRIAL 48mm +1.5

    BIPAP FOCUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bi-Blade Vitrectomy Cutter

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021

    CARETOUCH

    FDA Adverse Event
    Injury ·GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD·Product code DXN·July 10, 2023

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·December 5, 2008

    BD VACUTAINER BLOOD COLLECTION TUBE

    FDA Adverse Event
    Other ·BD·Product code JKA·September 1, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2013

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·May 19, 2021

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Recall
    Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 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