BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720341·GC Initial™ PC Pellets Occlusal OL-4, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709303·GC Initial™ PC Pellets Occlusal OL-4, 5pcs. X 2

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311848·Low Profile Screw, 2.0 x 34mm, Cortical

    Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    130 DEG AIMING ARM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·September 2, 2021

    CS300

    FDA Adverse Event
    Injury ·DATASCOPE CORP.·Product code DSP·April 17, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 8, 2010

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015