BEUDAMED
    20 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 17, 2013

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·November 29, 2017

    Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.

    FDA Enforcement
    Class II ·Terminated·Shippert Medical Technologies·August 30, 2017

    Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

    FDA Enforcement
    Class II ·Terminated·Signature Orthopedics Pty Limited·March 14, 2018

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    FDA Enforcement
    Class II ·Terminated·Southern Implants, (Pty.) Ltd.·April 25, 2018

    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

    FDA Enforcement
    Class II ·Terminated·Signature Orthopedics Pty Limited·February 20, 2019

    Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component

    FDA Enforcement
    Class II ·Terminated·Signature Orthopedics Pty Limited·February 20, 2019

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Cocoon Convective Warming System, Product Code: CWS5000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

    FDA Enforcement
    Class II ·Terminated·Signature Orthopedics Pty Limited·June 9, 2021

    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019