BEUDAMED
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    BIO-CHALLENGE TEST PAK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Richard Wolf GmbH·04055207010570·STABILISATION DISC Ø 5.5MM 86MM Length 152mm, ...

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209106257·KIT, M-FAK - ODG

    KHEIRON® Spinal Fixation System, including patient specific K-ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABL80 FLEX ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IDENTITY ADX XL DR

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·June 5, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 29, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010

    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015