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

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    ARTERIAL EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VENTURE™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000890247·PLATE 9790082 ANT CERV ASSY 82 5MM

    VENTURE™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902989193·PLATE 9790082 ANT CERV ASSY 82 5MM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196341·AK3 PS Femoral Trials Size 1 - 5 Left Pan

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515204089·Blunt Jaw Pliers, serrated 5 1/2"

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195047·AK3 PS Femoral Trials Size 1 - 5 Left Pan Insert

    Straumann BLX Variobase Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    BOTTLE, CONDENSATE (#1628)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 5, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 15, 2012

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·August 2, 2010

    UNSPECIFIED BD ALARIS INFUSION SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·May 28, 2021

    BD ALARIS¿ SECONDARY SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023

    UNSPECIFIED BD ALARIS¿ INFUSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024