BEUDAMED
    23 results · 33ms · Sources: EU EUDAMED, US FDA

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    CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304229945·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974025·UniTip High Resolution Catheter 10F

    SPINE WORKS COLLAR

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 7, 2022

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 9, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·September 19, 2014

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2011

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·October 15, 2025

    EVOLUT PRO PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·October 15, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·October 24, 2025

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·September 25, 2014

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·March 11, 2015

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Other ·SURGIQUEST, INC.·Product code HIF·December 12, 2013

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021