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

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    K121116

    FDA UDI
    Life Spine, Inc.·00190837016029·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016043·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016258·

    PLATEAU SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010061911·COMPRESSION HIP SCREW HEX HEAD COMPRESSING SCRE...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690130017·Retaining Bolt, PS or PS-C Insert, Revision Tib...

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180098·Integra® Jarit® Plastic And Reconstructive Need...

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321211160·

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PEDICLE SCREW 7X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·April 10, 2018

    Widex

    FDA UDI
    Widex A/S·05706069886085·WIDEX MOMENT MRB0 (Dark cherry ) 220, RIC 10

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    PEDICLE SCREW 7X50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·February 23, 2018

    PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·March 23, 2018

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    M.U.S.T. RODS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·April 20, 2026

    PEDICLE SCREW PEDICLE SCREW 5X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·January 17, 2024

    M.U.S.T. POLYAXIAL PEDICLE SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MNI·October 28, 2024

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025