BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INTELLIVUE MX40 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMORY CARDIAC TOOLBOX 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR·Product code OUT·December 18, 2012

    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 29, 2011

    UNKNOWN DEPUY HIP LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·August 28, 2008

    PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 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