BEUDAMED
    41 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·March 14, 2018

    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·July 8, 2015

    Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Dr Bragg Vein Tray - RX, part number 007912-8

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 18, 2018

    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 18, 2018

    HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    Laminectomy Pack, part number PSS1844(B

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016