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

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    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large

    SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113260·LOCATOR R-Tx Abutment for 5.5mm XiVE Connection...

    FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2020

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    EXCELSIOR SL-10 PRE-SHAPED 90 150CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR CORK·Product code DQY·April 22, 2013

    MATRIX2 FIRM 360 COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION·Product code HCG·July 7, 2008

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011

    CAPIOX FX25 OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 25, 2022

    CAPIOX FX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 26, 2024

    CAPIOX FX HOLLOW FIBER OXYGENATOR WITH HARDSHELL RESERVOIR, ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 10, 2023

    CAPIOX FX25

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·July 18, 2023

    CAPIOX FX15 OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 3, 2025

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 23, 2020

    CAPIOX CUSTOM PACK

    FDA Adverse Event
    Injury ·TERUMO MEDICAL CORPORATION·Product code DTZ·June 10, 2023

    CAPIOX CUSTOM PACK

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 10, 2023