BEUDAMED
    84 results · 18ms · Sources: EU EUDAMED, US FDA

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    ACTICOAT FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    CHATTANOOGA

    FDA UDI
    DJO, LLC·00888912151467·OptimA,Medium 2.0cc electrode, Box of 12

    Bio2 Technologies

    FDA UDI
    BIO2 TECHNOLOGIES, INC.·B01010000511·VITRIUM E 22 x 9

    RINGFIX

    FDA UDI
    Stryker GmbH·00886385009889·Half Pin System Tray (Empty); GEN II

    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023

    RINGFIX

    FDA UDI
    Stryker GmbH·00886385009896·Half Pin Gen II Tray; Lid

    QB1 NMES System

    FDA UDI
    Motive Health, Inc.·00854816006257·QB1 Post-Op Brace, NMES System; LARGE, SHORT, R...

    e-vive NMES System

    FDA UDI
    Motive Health, Inc.·00854691008087·e-vive Bilateral NMES System; Small / Medium

    PRECHOPPER COMBO CROSS SECTION SHARP TIP

    FDA UDI
    DAUD JEE MFG. CO·G006D5060000510·This instrument is used to grasp, retract, or s...

    51mm Single-Use Acetabular Reamer

    FDA UDI
    Osteofit LLC·00850032869072·

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830830000510·3-Level, 51mm Cervical Plate

    Preference 2

    FDA UDI
    SINTX Technologies, Inc.·M555281000051·5.5mm Polyaxial Screw Caddy, Complex Spine Tray 4

    MODIFIED HYDROPHILIC COATED GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·July 22, 2025

    ACUFEX, 4.5MM CANN. ENDOSCOPIC DRILL

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC. ENDOSCOPY DIVISION·Product code HTW·July 7, 2000

    ACUFEX, 4.5MM CANN. ENDOSCOPIC DRILL

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC. ENDOSCOPY DIVISION·Product code HTW·July 7, 2000

    LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·September 10, 2025

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013