BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    OSTRONCS HEMI-HIP STEM SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123793·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 150mm

    XHIBIT CENTRAL STATION, MODEL 96102

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·May 30, 2014

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010

    FOLEY CATHETER, 2W STD SLC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code KOD·January 16, 2013

    PSI SD800.434 PEEK IMPLANT

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GXN·December 11, 2018

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

    FDA Enforcement
    Class I ·Ongoing·Abbott·October 22, 2025

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024