BEUDAMED
    35 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    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

    Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room

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

    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

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. 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

    2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

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

    Syngo.via systems with SW VB20A

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 7, 2018

    Facial Plastic Pack, part number AMS3327(C

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

    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room

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

    Minor Procedure Pack, part number AMS4799

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

    Knee Scope Pack, Kit number AMS2498 and AMS2498(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 Tray AMS2685 convenience custom kits used for general surgery in hospital operating room

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

    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

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

    Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

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

    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corp·December 30, 2015

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Upper Torso Tray, Kit number PSS1554(B 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

    Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room

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

    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

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

    Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room

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