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

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    V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CENTRIMAG MOTOR

    FDA UDI
    Thoratec Switzerland GmbH·07640135140078·

    SPONDY SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERCISE GENUS

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 14, 2023

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2013

    DURA DURATION A/P TIB LG 9

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·September 19, 2014

    IAB: 8 FR - 30 CC

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·May 4, 2011

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    FDA Enforcement
    Class I ·Terminated·Thoratec Switzerland GMBH·November 6, 2019

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

    FDA Recall
    Terminated ·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·September 5, 2018

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    FDA Recall
    Terminated ·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·August 22, 2019

    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

    FDA Enforcement
    Class II ·Terminated·Thoratec Switzerland GMBH·October 24, 2018

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026