BEUDAMED
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    MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048305228·ARC ATTACHMENT WITH INDEX

    Bard Poly Midline

    FDA UDI
    Bard Access Systems, Inc.·00801741108051·Catheter Placement Kit

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0005661·CC/ Effect Enamel SI-02 medium yellow

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782021569·CC/ Effect Enamel SI-02 medium yellow

    intellijoint KNEE®

    FDA UDI
    Intellijoint Surgical Inc·00628184005668·Rotational Sizer Interface

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450052730·

    SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 18, 2019

    HEART LUNG MACHINE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code KFM·December 22, 2025

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 12, 2013

    RF MULTIGEN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·February 1, 2011

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·February 15, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2015

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·February 14, 2018

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012