BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    MICROTAINER BRAND TUBE WITH EDTA(K2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRO-SYS

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975054562·

    Varex Imaging

    FDA UDI
    Varex Imaging Nederland B.V.·08718755001815·The device is intended to be used in medical di...

    DERMAFINE

    FDA 510(k)
    FDA Unclassified ·Unknown

    WELLNESS/JOLIVETE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 16, 2013

    NEXGEN LPS ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·December 23, 2010

    AVALON FM30 FETAL MONITOR

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code HGM·July 8, 2014

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023