BEUDAMED
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    ORGENTEC ANTI-SM ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295241010·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING CURVED...

    VOYAGER PACS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·January 24, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 28, 2014

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 17, 2011

    1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021