BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    ANAX 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613088385·Ballenger V-Shaped Chisel, 6mm Wide

    HALIFAX BIOMEDICAL TANATLUM BEAD SET

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

    BRIVO MR355, OPTIMA MR360

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019

    FAST-FIX 360

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code GAT·June 3, 2013

    530 G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 29, 2011

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

    FDA Enforcement
    Class II ·Ongoing·Thoratec LLC·January 21, 2026