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

    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.

    FDA Enforcement
    Class II ·Terminated·PhotoMedex, Inc.·April 29, 2015

    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

    Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012

    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012

    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012

    Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012

    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

    FDA Enforcement
    Class II ·Terminated·Mercedes Medical, Inc.·July 21, 2021

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Enforcement
    Class II ·Terminated·BRAEMAR, INC.·July 10, 2013

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Enforcement
    Class II ·Terminated·BRAEMAR, INC.·July 10, 2013

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·October 2, 2013

    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 13, 2017

    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 11, 2016

    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

    FDA Enforcement
    Class II ·Terminated·Gentherm Medical, LLC·July 28, 2021