BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704605·GC Initial™ IQ/ Layering-over-Zircon Body B, 50g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740041·GC Initial™ Ti Powder Opaque OA3.5, 20g

    ESCHMANN TDB50 BIPOLAR COAGULATION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MYCOBIOTIC AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Span-America

    FDA UDI
    SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300387400400·ZIMMER SKIN TRAC X-LG 225/CS

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code MFK·November 17, 2022

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·October 15, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 21, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 14, 2012

    Pressure Monitoring Tray, C-PMSY, G02854

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 10, 2020

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·April 21, 2023

    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

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017