BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    HemiCAP MTP Resurfacing Hemi-Arthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Low Profile Acetabular Reamer 54

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057572·

    THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    PLUM A+ UK WITH 3PIN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 28, 2011

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 6, 2014

    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 14, 2016

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    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