BEUDAMED
    17 results · 17ms · Sources: EU EUDAMED, US FDA

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    SCHOLTEN FRAME

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004059·PowerChem Neoprene Exam Gloves, Extra Large

    Retention Cuff Inflator

    FDA UDI
    Bracco Diagnostics Inc.·10815112021228·One Shot Cuff Inflator

    Retention Cuff Inflator

    FDA UDI
    Bracco Diagnostics Inc.·10815112020887·One Shot Cuff Inflator

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746135545·DB BKT MASTER MAX RIGHT CUSPID 018 T-7 A+8 R=0

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981129521·Screw Depth Adjuster, T30, Axial

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584474·Apex Tibial Nail Ø 9.0 x 405mm

    INTERCURE LTD. RESPI-LOW

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIPIDPRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2014

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code JDI·January 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2010

    SMR GLENOSPHERE Ø 40MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·December 15, 2021

    SMR CTA HUMERAL HEAD Ø50 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 29, 2022

    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, 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