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

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    PIONEER LATERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 15, 2013

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047300176·Headless Compression Screw, Cannulated, D=2.0mm...

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020258·Blue Silicone Tungsten Hurst Esophageal Dilator...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450414118·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193532·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327044478·Cruciate Retaining Tibial Insert

    DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSSEOTITE II MODEL XIFOSSXXX

    FDA 510(k)
    FDA Class 2 ·Dental

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 22, 2013

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·May 20, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    UNIVERSAL INSET PAT 32-4MM PEG

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 14, 2008

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 11, 2024

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2013

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HWC·January 23, 2026

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

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