BEUDAMED
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    FLO ASSISTANT, MODEL 4-250-00

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092103593·Straumann® TL WN-compatible Non-Engaging Gold/P...

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143251·

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18052469476703·FITBONE TROCHANTERIC TRIAL NAIL L325MM D11MM

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001325·artVeneer life lower anteriors, UBIM, C1

    Immunalysis Corporation

    FDA UDI
    IMMUNALYSIS CORP·00840937108024·Immunalysis Corporation cTHC Urine Calibrator L...

    Rampart One Lumbar Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7401001325·Trial 16mm L 12°

    Midmark IQecg® Digital ECG

    FDA UDI
    MIDMARK CORPORATION·00841709100901·The IQecg®from Midmark is an easy-to-use, digit...

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 4, 2021

    LIFECARD CF COMPACT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    VENACURE NEVERTOUCH

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code GEX·March 6, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 24, 2011

    ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·February 19, 2008

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 18, 2023

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

    FDA Enforcement
    Class I ·Ongoing·Fresenius Kabi USA, LLC·September 11, 2024

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FPA·August 1, 2024