BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

    MaxFuse,VBR, 12 (D) x 14 (W) x 14 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055912·12 (D) x 14 (W) x 14 (H)

    Endo-Model Knee System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575303076·Knee femur prosthesis trial - General Instrument

    DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING

    FDA 510(k)
    FDA Class 1 ·Dental

    RN SYNOCTA TEMPORARY MESO ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 6, 2011

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 8, 2014

    D902 LILLIPUT ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022

    LILLIPUP PMP, LILLIPUT PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019