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

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    OSS/Arcos IM Total Femur Rod

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Signature Femoral Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215001926·

    Paxeon Femoral Head

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570200146·Paxeon Head, Ceramic Size 32mm S

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111526210·Ceramic Femoral Head, 32mm, S (-4.0 mm)

    SOLSTICE

    FDA 510(k)
    FDA Class 2 ·Dental

    1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGNATURE Head - BIOLOX Delta

    FDA UDI
    AMPLITUDE SAS·03701089520751·

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 8, 2014

    THERAPY COOL PATH CATHETER, 1304-CP-7-25-L-AB (USA)

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·June 5, 2013

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 22, 2011

    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

    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 Recall
    Terminated ·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023