BEUDAMED
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    CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Stimwave Freedom Spinal Cord Stimulation System

    FDA UDI
    STIMWAVE TECHNOLOGIES INCORPORATED·00818225022086·Torso Belt Size XXL Assembly

    Freedom System Accessories

    FDA UDI
    Curonix LLC·00850051034512·Torso Wearable XXL

    VARISEED 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    FDA 510(k)
    FDA Class 2 ·Immunology

    BEAVER XSTAR

    FDA Adverse Event
    Malfunction ·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNN·October 25, 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

    PSI 100*60*40 PEEK

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code GXN·April 11, 2013

    CHARGER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·September 2, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 11, 2025

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·October 10, 2024

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·August 15, 2024

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·September 4, 2024

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·October 7, 2024

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·October 3, 2024

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·March 2, 2016

    MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

    FDA Enforcement
    Class II ·Ongoing·Mazor Robotics Ltd·October 18, 2023

    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013

    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.

    FDA Recall
    Terminated ·Monteris Medical Corp·Product code GEX·October 5, 2017