BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Approach CTO Microwire Guide

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·Product code DQX·May 21, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·December 28, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 17, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 3, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·October 31, 2023

    ABL90

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ORTHOSIS,PEDICLE SPINAL FIXATION

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MNI·December 8, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 7, 2013

    BARDPORT IMPLANTED PORT

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code LJT·September 13, 2007

    PLATE ADAPTER DIST. LAT. FEMUR RIGHT

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·May 11, 2017

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 25, 2015

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Ingenia 3.0T-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 Models: 781342 781377

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