BEUDAMED
    8 results · 19ms · 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 ×

    Respiration Data Management Software (PAP Link PC)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Burr

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113165·DIAMOND BURR 5.0MM DIAMETER DISC

    GEMINI GXL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CareEvent

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PINNACLE PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FTM·November 21, 2008

    FORTIFY VR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2013

    PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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