BEUDAMED
    34 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

    FDA Enforcement
    Class II ·Ongoing·Conformis Inc.·April 23, 2025

    Identity Imprint PS Tibial Tray Size 4: Lot 540287

    FDA Enforcement
    Class II ·Ongoing·Conformis, Inc.·April 24, 2024

    CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

    FDA Enforcement
    Class II ·Ongoing·Conformis, Inc.·August 23, 2023

    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·January 18, 2017

    Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·February 21, 2018

    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·January 23, 2019

    ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·December 7, 2016

    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.

    FDA Enforcement
    Class II ·Terminated·Conformis Inc·August 29, 2012

    ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·December 17, 2014

    ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015

    ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)

    FDA Enforcement
    Class II ·Terminated·ConforMIS, Inc.·October 28, 2015