BEUDAMED
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    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Reprocessed Arthrex 3.2mm Drill Bit, Cannulated

    FDA UDI
    SURETEK MEDICAL·B390AR8750041·Arthrex Drill Bit, Cannulated, 3.2mm

    Arthrex

    FDA UDI
    Provision·B504OMAR8750040·

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867266049·DRL BIT, 3.2MM, CANN.

    SWELL-RELIEF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CRIB CUDDLE - INFANT BED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867319561·3.2MM DRL BIT, CANNULATED, REUSABLE

    AUTOSOFTÂ XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 30, 2024

    AUTOSOFTÂ XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 30, 2024

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·June 2, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIVISION·Product code FPO·October 13, 2010

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/20MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·December 17, 2012

    Presource PBDS, Shoulder Procedure, Kit, Circulator

    FDA Enforcement
    Class I ·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013

    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