BEUDAMED
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    STRYKER PRECISION DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Bosworth Ultra Trim

    FDA UDI
    Harry J Bosworth Company·H66809218051·Bis-Acryl C&B Kit, A3.5

    SEAL & PROTECT PROTECTIVE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    AMS LARGE PORE POLYPROPHLENE MESH

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

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 6, 2010

    AMS SPHINCTER 800 URINARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·January 15, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·August 27, 2020

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022