BEUDAMED
    12 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.

    FDA Enforcement
    Class II ·Terminated·Nipro Diagnostics, Inc.·February 12, 2014

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    FDA Enforcement
    Class II ·Terminated·Nipro Diagnostics, Inc.·April 24, 2013

    BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.

    FDA Enforcement
    Class II ·Terminated·OPTI Medical Systems, Inc·October 3, 2012

    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

    FDA Enforcement
    Class II ·Terminated·MTI Precision Products LLC.·July 23, 2014

    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

    FDA Enforcement
    Class II ·Terminated·OPTI Medical Systems, Inc·October 30, 2013