BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100332·BARRAQUER INFANT WIRE SPECULUM

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 20, 2020

    PF4 ENHANCED SOLID PHASE ELISA

    FDA 510(k)
    FDA Class 2 ·Hematology

    LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXTAR INFRARED CAMERA

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·June 30, 2011

    UNIFY ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    FUSION ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021

    EDI BZO Uncut Sheet - Cup*, Item No. 160170

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

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024