BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Bernafon AG·05711584090329·ZERENA 1 MNR T FW 3.0

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197194549·Ferreira Style Breast Retractor 190x25...

    VIDAS® RUB IGG II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFX·August 21, 2018

    VISION SCIENCES FLEXIBLE ENT SCOPE

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

    2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 18, 2014

    CYLOS DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO KG·Product code DTB·June 30, 2011

    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 14, 2019

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 11, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2022

    STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019