BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169606197·SPACER 2133550 OLIF25 27MM 18 DEG 16X50

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035521·3.5mm x 50mm Locking Screw

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK

    YOBOSHI DENTAL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    DXL CALSCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    TINBN VANGUARD INT PS ANAT FM R 65MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·March 7, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 15, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 22, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023