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

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    BASAL DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Lifeshield

    FDA UDI
    ICU Medical, Inc.·10887787005131·LIFESHIELD, Extension Set - 15 Inch, 1.2 Micron...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088025·UTERINE DILATOR, HEGAR, 5.5MM DIAMETER

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037503·Unitek(TM) Bicuspid Band General Purpose Narrow...

    Verteloc Spinal System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215129019·

    FO NX Nail System

    FDA UDI
    FIELD ORTHOPAEDICS PTY LTD·09353903012603·1.4 Double-ended Trocar K-wire 150 mm 5/pkg

    RTVUE CAM WITH CORNEAL POWER UPGRADE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RTVUE MODEL RTVUE 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    BD NOKOR FILTER NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·October 27, 2020

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·February 8, 2012

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    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