BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Modified Bencox Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490542722·ADAPTER 9150007 CYLINDRICAL CAGE 24MM

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756611602·CAST BOOT

    NUTRI-LOK

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67141500070·NUTRI-LOK CONTINUOUS FEED ADAPTOR

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075022385·KLEOS PSL METAL ROTH 022 UL45 PK5 UNI

    ABACUS TM SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLEEP PROFILER

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    Zimmer, Inc.·00889024033603·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 6, 2013

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JQX·July 5, 2011

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·August 27, 2008

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    FDA Enforcement
    Class I ·Terminated·Merit Medical Systems, Inc.·April 5, 2017

    7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·February 16, 2017