BEUDAMED
    23 results · 24ms · Sources: EU EUDAMED, US FDA

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    ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Premier Carvers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783009309·CARVER DE ROACH

    ZEVO™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000663131·PLATE 3003069 ZEVO 69MM 3 LVL

    ZEVO™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169329560·PLATE 3003069 ZEVO 69MM 3 LVL

    Premier Carvers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783009293·Carver DE_Ward 1S

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523132508·3-Level Anterior Cervical Plate, 69mm

    MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    V500, SAVINA AND VENTILATORS OF EVITA FAMILY

    FDA Adverse Event
    Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 13, 2013

    K-WIRE, RECON 3.2X400 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HTY·February 8, 2011

    LIFE PULSE HIGH FREQ. VENTILATOR W/PATIENTBOX

    FDA Adverse Event
    Other ·BUNNELL, INC.·Product code LSZ·February 25, 2008

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MFK·November 19, 2024

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013