BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    TOMi Scope

    FDA 510(k)
    FDA Class 2 ·Radiology

    CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    GIRAFFE AND PANDA WARMERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·October 1, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013

    INTRATHECAL CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 22, 2011

    SPECTRA OPTIA

    FDA Adverse Event
    Injury ·TERUMO BCT·Product code LKN·August 18, 2020

    SPECTRA OPTIA

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·March 15, 2021

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 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