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

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    Power wheelchair

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631381·CoRoent Ant TLIF Ti, 14x12x40mm 12°

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)

    BigEasy Non-Rebreathing Valve

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ACCUSTICK? II

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code DYB·November 11, 2014

    ATLAS PLUS DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011

    ASPHERE M SPEC 12/14 36 +5

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 23, 2013

    PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014