BEUDAMED
    9 results · 34ms · Sources: EU EUDAMED, US FDA

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    TRANSGROW MEDIUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 27, 2014

    RETROFLEX 3 INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·November 14, 2012

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2015

    11.0MM TI HELICAL BLADE 100MM-STERILE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 15, 2021

    11.0MM TI HELICAL BLADE 100MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·February 17, 2016

    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·June 22, 2016