BEUDAMED
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    DELFIA FREE THYROXINE (FT4) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867201750·PIN GUIDE, MULTIPLE PARALLEL

    VAPLOK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C4 ANTIGEN ANTIBODY CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRILOGY ACETABULAR SYSTEM SHELL SPIKED POROUS

    FDA Adverse Event
    Malfunction ·ZIMMER·Product code LPH·May 14, 2010

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 19, 2014

    HYPERBARIC VENTILATOR

    FDA Adverse Event
    Malfunction ·SECHRIST INDUSTRIES, INC.·Product code CBK·December 27, 2012

    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

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021