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

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    Noris Medical MBI-2mm Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517567017·CoRoent Ant TLIF PEEK, 16x12x30mm 8°

    BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304001114·

    BI-METRIC INTERLOK HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222700·

    K162309

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

    LMT-KATH-S; LMT-KATH-I

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 25, 2019

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 11, 2013

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·July 7, 2011

    MTOME ST HOLSTER/CABLES

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

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 1, 2024

    M2A-MAGNUM 42-50MM TPR INSRT-6 0/-6MMT1

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 1, 2024

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 1, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Death ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    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