BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    Dermablate

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

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517444387·SpheRx® II Conn, 60mm Transverse Fixed

    Measuring Device

    FDA UDI
    ADLER ORTHO SPA·08050507139323·SICKLE-SHAPED MEASURING DEVICE

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776090616·Debakey Multi Purpose Clamp

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702782462·ELVAREX 2/KNEE HIGH/OPEN TOE/DENIM

    Acetabular reamer ø46mm

    FDA UDI
    Incipio Devices SA·07630055301505·Acetabular reamer for hip arthroplasty

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160175·Integra® Miltex® DeBakey Multi-Purpose Clamp, 1...

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 14, 2002

    QWIKCHECK-BEADS

    FDA 510(k)
    FDA Class 2 ·Hematology

    NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·November 20, 2008

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (SHANGHAI)·Product code GEI·September 2, 2011

    PROFEMUR(R) L HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·July 22, 2013

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·May 7, 2024

    Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·December 18, 2009

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014