BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH

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

    BOSS-2000-2 VACUUM ERECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 25, 2023

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 31, 2023

    BD INSYTE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 11, 2023

    LOGIC CR TIB INSERT STD, SZ 5, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 7, 2024

    BD INSYTE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 14, 2023

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·April 29, 2013

    1030489-2011-00533

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·May 10, 2011

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM GREEN

    FDA Adverse Event
    Malfunction ·POWER MEDICAL INTERVENTIONS·Product code GDW·July 23, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012