11 results
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14ms
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Sources: EU EUDAMED, US FDA
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 20, 2012
Multitom RAX with software version VF10
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014
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