BEUDAMED
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    Microvolume Luer Access Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Signature BiPolar Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215017293·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161112128420·Bipolar Head size 42

    V*CARE MANUAL RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AMS ELEVATE PC

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    FLAT TITANIUM PECTUS BAR 10.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 12

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    UNKNOWN LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 9, 2013

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 12.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023