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

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    CALLOS CMF BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Neurology

    K042172

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022

    VOXAR VC, MODEL 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROLITE VL PULSED LIGHT SYSTEM

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 25, 2023

    APHIS PLATEAU RADIAL T1

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWJ·May 19, 2017

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·April 3, 2013

    LAMITRODE S8 SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 31, 2011

    ENDOTAK SQ PATCH

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024