BEUDAMED
    9 results · 33ms · 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.

    SURGICAL MICROSCOPE DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SAFETY NEEDLE SHEATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·March 28, 2017

    PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.,·Product code JOH·June 28, 2016

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 5, 2013

    PLMA DVC V11. 51 1 R

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·December 6, 2010

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·July 18, 2014

    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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