BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    OPTIBOND-D

    FDA 510(k)
    FDA Class 2 ·Dental

    DSS Sinusplasty Balloon Catheter

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2010

    SENSAR

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HQL·February 5, 2013

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 18, 2014

    PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021