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

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    BDC Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613111021·Vannas Capsulotomy Scissors, Straight, Sharp Po...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613111014·Vannas Capsulotomy Scissors, Curved, Sharp Poin...

    iTotal Posterior Stabilized (PS) Knee Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK, MODEL 1000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ALARIS SYSTEM

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

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·November 21, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

    11.0MM TI HELICAL BLADE 90MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·July 23, 2013

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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