BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    ChartCheck

    FDA 510(k)
    FDA Class 2 ·Radiology

    OneLIF™

    FDA UDI
    Novapproach Spine LLC·G07001322011190·Retention Plate, Anterior-Only, Medium, 11 mm -...

    ESOP®

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489011191·

    POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ROVERS ENDOCERVEX-BRUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Widex

    FDA UDI
    Widex A/S·05706069710380·Widex EVOKE E-FS (Silver Grey ) Telecoil, RC coil

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Death ·HEARTWARE, INC·Product code DSQ·October 27, 2014

    PARADYM

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA S.R.L.·Product code MRM·June 28, 2013

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·July 29, 2011

    WALLFLEX COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024

    WALLFLEX COLONIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

    NEEDLE SFTYGLD 25X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·December 7, 2023

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012