BEUDAMED
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    COMPANION SPEECH AID, MODEL 432

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756378161·ORTHO SPORTS KNEE ARTHROSCOPY PACK

    LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 28, 2020

    SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE

    FDA 510(k)
    FDA Class 2 ·Dental

    AIA-PACK BRCA, ST AIA PACK BRCA

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNKNOWN RIGHT HIP NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWY·January 8, 2013

    PUMP MMT-722LCAL PRDGM INS CL EN LN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·November 22, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014

    BD BACTEC FX, INSTRUMENT TOP, PACKAGED

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 22, 2021

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

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