BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    AVENIR MULLER STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032966·Set Up Pack, Urology

    ArgenZ ST 98x18 ML OM2

    FDA UDI
    ARGEN CORPORATION, THE·D818123392·Dental porcelain/ceramic restoration kit

    NOVO Health Services, LLC

    FDA UDI
    SRI Healthcare, LLC·00810019801938·Set Up Pack, Urology

    CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AGC SPECIAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    ALT HA S CLR EXT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 10, 2011

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

    THREE PEG PATELLA 41MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 26, 2025

    BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 27, 2017

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 1, 2024

    NV GXL LINER LIPPED 36MM ID GROUP 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021