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

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    VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Equinoxe

    FDA UDI
    Exactech, Inc.·10885862610911·Baseplate Trial, L Superior Post Aug

    ADVIA CENTAUR HOMOCYSTEINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GUARDED NEEDLE 2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUVASIVE

    FDA Adverse Event
    Injury ·NUVASIVE·Product code NKB·January 10, 2011

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 11, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·March 15, 2011

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable Stainless Steel Surgical Instrument Part Number: 125382A

    FDA Recall
    Terminated ·Tnco, Inc.·Product code GCK·December 2, 2005

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    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