BEUDAMED
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    TINA-QUANT CRP (LATEX)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032336·Baltic Denture System BDLoad Sm6 PLSEbm6DFs A1pink

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120323361·Diamond, flame, COOL DIAMANT, coarse grit, gree...

    MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017

    PREPMATE ACCESSORY

    FDA Adverse Event
    Malfunction ·TRIPATH IMAGING, INC.·Product code MKQ·September 25, 2008

    PREPMATE ACCESSORY

    FDA Adverse Event
    Malfunction ·TRIPATH IMAGING, INC.·Product code MKQ·August 6, 2008

    PREPMATE ACCESSORY

    FDA Adverse Event
    Malfunction ·TRIPATH IMAGING, INC·Product code MKQ·July 8, 2009

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    OLYMPUS/GYRUS ACMI

    FDA Adverse Event
    Malfunction ·GYRUS ACMI·Product code FAS·March 10, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·April 21, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016