BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052025373·Aggressive Full Radius Resector 3,5

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515018594·Roch-Pean Hemo Fcps, cvd, 12"

    JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALCOMATE, MODEL CA2000

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

    AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

    AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

    AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    CLINAC

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·June 1, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022