BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    MEDISIZE GOLD HEATER AND BOOSTER T-PIECE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Simpliciti™

    FDA UDI
    TORNIER, INC.·00846832061358·

    Tornier Simpliciti® Shoulder System

    FDA UDI
    TORNIER, INC.·00846832091577·

    LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·December 3, 2015

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    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