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

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    Simple Science Antimicrobial Facial and Eyelid Cleanser

    FDA 510(k)
    FDA Unclassified ·Unknown

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515024892·Middledorpf Retractor, ring handle, 7x14mm, 8"

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    COREVALVE 29MM AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 17, 2014

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·June 20, 2013

    PCA PLS II

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 7, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018