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

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    HYGIENA-TRACH

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756393980·MAJOR BLEPH PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112342·SURG-I-BAND ORANGE GLOW

    TAPAS® Catheter

    FDA UDI
    Thermopeutix, Inc.·M7819110801·The TAPAS® Catheter consists of a two concentri...

    Ambu aScope 4 RhinoLaryngo Slim

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CER OPTION TYPE 1 TPR SLEVE +6

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 9, 2023

    EXETER V40 STEM 35.5MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·January 4, 2013

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·November 30, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014

    CER OPT TYPE 1 TPR SLEVE 0MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 9, 2023

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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