BEUDAMED
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    PSI CALCIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788224690·Cervical Rasp +DS 6x12x12

    ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECO E4

    FDA 510(k)
    FDA Class 2 ·Dental

    STERLING?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 21, 2014

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    FDA Adverse Event
    ETHICON ENDO-SURGERY, INC.·Product code GDW·October 23, 2012

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·August 26, 2010

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025