BEUDAMED
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    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    FDA 510(k)
    FDA Class 2 ·Immunology

    Safco T&F Bur - 12 Bladed

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310220173·Safco T&F bur - 12 bladed, carbide, #7901 needl...

    infinity OCTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220171·BL NC Healing abutment, conical Ø3.6 mm GH 2.0 ...

    Flex-TENS Retail 022017

    FDA UDI
    Emsi·00858688006957·

    Flex-IT Retail 022017

    FDA UDI
    Emsi·00858688006940·

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710460220170·Lateral Guide, Closing Wedge Osteotomy, 22mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310220170·Talar Osteotmy Guide, 22mm x 17mm

    VARISEED 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDX 1000 SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 26, 2013

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD)·Product code KNT·March 31, 2008

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·March 1, 2017

    CIRCON ACMI CYSTOSCOPIC INSTRUMENTATION

    FDA Adverse Event
    Injury ·CIRCON ACMI·Product code FAJ·September 29, 1995

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·October 19, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·February 21, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·June 29, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·August 28, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 28, 2017