BEUDAMED
    259 results · 37ms · 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 FDA Enforcement ×

    Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 5, 2016

    RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    McKesson Cardiology Hemo

    FDA Enforcement
    Class II ·Terminated·Change Healthcare Israel Ltd.·June 5, 2019

    Horizon Cardiology Hemo

    FDA Enforcement
    Class II ·Terminated·Change Healthcare Israel Ltd.·June 5, 2019

    FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·November 7, 2012

    RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·July 3, 2013

    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.

    FDA Enforcement
    Class II ·Terminated·Zeiss, Carl Inc·January 29, 2014

    SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

    FDA Enforcement
    Class III ·Terminated·Synthes (USA) Products LLC·November 11, 2020

    STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

    FDA Enforcement
    Class III ·Terminated·Synthes (USA) Products LLC·November 11, 2020

    END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

    FDA Enforcement
    Class III ·Terminated·Synthes (USA) Products LLC·November 11, 2020

    3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

    FDA Enforcement
    Class III ·Terminated·Synthes (USA) Products LLC·November 11, 2020