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

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    Oragene®•Dx

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RANGE SPINAL SYSTEM (MESA AND DENALI)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    UNKNOWN COMPREHENSIVE REVERSE TAPER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·November 16, 2016

    COMP RVSR SHLDR GLNSP +3 36MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HSD·May 26, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 27, 2013

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·June 15, 2011

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·June 14, 2017

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018