BEUDAMED
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    MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284676·

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809845471·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE ...

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124580·Modular Offset Stem 17mm x 100mm x 4mm

    ECG

    FDA UDI
    Zoll Medical Corporation·00847946021825·12 LEAD ECG LIMB LEAD, 7FT BLACK

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

    CLEARFIL ST OPAQUER

    FDA 510(k)
    FDA Class 2 ·Dental

    KSEA MINIATURE NEUROENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020

    SILICONE INJECTION

    FDA Adverse Event
    Injury ·UNK·Product code KGM·April 5, 2013

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·April 7, 2011

    PROVISC

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.·Product code LZP·April 23, 2008

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 2021

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    FDA Recall
    Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

    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