BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    Single Use Balloon Dilator V (with knife)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SMITH & NEPHEW RADIOPAQUE TRIAL NECKS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CDI BLOOD PARAMETER MONITORING SYSTEM 500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 22, 2011

    HANDLE ACETABULAR PRESS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    ACETABULAR PRESSURIZER SMALL

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016