11 results
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6ms
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Sources: EU EUDAMED, US FDA
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics Llc·September 26, 2012
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics Llc·December 12, 2012
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Butterfly Network, Inc.·April 8, 2020
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