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

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    UNIFAST III

    FDA 510(k)
    FDA Class 2 ·Dental

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

    PROMOTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    2 PIECE MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 17, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023

    METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024