BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Stryker MIS Attachments and Cutting Accessories

    FDA 510(k)
    FDA Class 2 ·Neurology

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·November 11, 2024

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 11, 2014

    MAXI MOVE

    FDA Adverse Event
    Other ·ARJO HOSPITAL EQUIPMENT AB·Product code FNG·July 6, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 23, 2013

    E1 44-41 RTNV +3 HMRL BRG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 24, 2021

    PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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