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

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    SomnoDent ALPHA

    FDA 510(k)
    FDA Class 2 ·Dental

    BI-METRIC INTERLOK HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222687·

    K162309

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 21, 2023

    PLASMACON N, PLASMACON L-1, PLASMACON L-2

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYNOVIS COLLAGEN MATRIX (TBD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2, BASAL-IQ, MMOL/L

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 18, 2020

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 26, 2011

    PFC SIGMARP STB TB IN 3 10.0

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·July 7, 2011

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 26MM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 11, 2013

    MTOME ST HOLSTER/CABLES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KNW·September 8, 2008

    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