BEUDAMED
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    ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 2, 2023

    CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DELTA CERAMIC FEM HD 36/-3MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·November 11, 2019

    DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 10 HOLE / L238MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA SELZACH·Product code HRS·October 1, 2014

    ESSURE

    FDA Adverse Event
    Injury ·Product code HHS·May 17, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    VORTEX

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC·Product code LJT·October 22, 2024

    VORTEX

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC·Product code LJT·October 23, 2024

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015