BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    VASCUTRAK PTA DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: BIOMET HUMERAL CABLE PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTOUR

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NMJ·April 12, 2013

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 20, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 20, 2011

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·May 20, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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