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

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    SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

    FDA 510(k)
    FDA Class 2 ·Radiology

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721391·Frazier Ferguson Suction Tube 14Fr. (4.8mm), w/...

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 14, 2019

    ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIMADZU COLLIMATOR R-30H

    FDA 510(k)
    FDA Class 2 ·Radiology

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 19, 2020

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC.·Product code MUJ·July 28, 2021

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 15, 2019

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 14, 2019

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·October 2, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CCW·June 21, 2013

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC·Product code MUJ·August 25, 2021

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    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