BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707015253·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 33

    IMMULITE/IMMULITE 1000 TURBO INTACT PTH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 22, 2016

    CAPSUREFIXNOVUS

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

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

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

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 21, 2011

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 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

    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

    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