BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    PROVI CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Plum

    FDA UDI
    ICU Medical, Inc.·10887787003434·Primary PLUM MICRODRIP Set CLAVE Secondary Port...

    Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003463·Dental Composite Resin

    Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172011969·Dental Composite Resin

    Brasseler USA

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919913634·EVANESCE AU CMP SAMPLE 75PK

    UNITY Sacroiliac Joint Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAKO(TM) AUTOKIT CK-NAC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 21, 2013

    MINI-CAP WITH POVIDONE LODINE

    FDA Adverse Event
    Malfunction ·Product code KDI·January 28, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 1, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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