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

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    AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700331·GC Initial™ MC Opaqus Dentin ODA3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556702007·GC Initial™ MC Opaqus Dentin ODA3, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·10888867312774·Guidewire, Trocar, 1.1mm

    MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPAC TM T3 UPTAKE KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IRIDEX MICROPULSE P3 PROBE

    FDA Adverse Event
    Injury ·IRIDEX CORP.·Product code GEX·July 27, 2022

    PINNACLE MTL INS NEUT28IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 12, 2014

    UNKNOWN STRYKER LEFT KNEE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·December 4, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 25, 2015

    SILK SUTURE 30"(75CM) 5-0 BLK

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAP·December 22, 2020

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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