BEUDAMED
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    EXPRESSSUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013267·Zirlux 16+ B4 98.5X12

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964153136·Endo Carry-on Procedure Kit contains Basins, VI...

    Extend Frame system

    FDA UDI
    Elekta Instrument AB·07340048306737·MIXER AND DISPENSER

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033214572·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033214558·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033214589·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033214565·

    COMFORT

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 23, 2025

    PULSECO HEMODYNAMIC MONITOR CM71

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 27, 2012

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 14, 2022

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·February 10, 2023

    AXON PATIENT MODULE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·March 14, 2013

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code FGE·March 8, 2011

    QUICKSITE XL LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    Set-Up Pack, part number PSS1305(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    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