BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Neurology

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169502277·INTERBODY 2152112 SMALL - 12 DEG 12MM

    Eagle Derma2 Nitrile Examination Gloves

    FDA UDI
    Eagle Protect Pbc·09421024254681·Derma2 Nitrile Examination Gloves, Black, Powde...

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054588·

    Simpact Tri-Fin

    FDA UDI
    Life Spine, Inc.·00190837062712·#2 Dilation Tube, Aluminum

    XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CRITICOOL PRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·October 8, 2014

    INSYNC III PROTECT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 29, 2020

    2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 29, 2020

    2.0 LACTOSORB SYSTEM STRAIGHT PLATE - 6 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 29, 2020

    2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 29, 2020

    ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Allura Xper FD10/10; Model Number: 722011;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024