BEUDAMED
    14 results · 86ms · Sources: EU EUDAMED, US FDA

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    ARCTIC GEL PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·August 5, 2020

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·February 25, 2021

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·January 20, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 15, 2021

    SURGICAL ORTHO U DRAPE 10

    FDA Adverse Event
    Injury ·O&M HALYARD, INC.·Product code PUI·September 10, 2025

    NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10 MG

    FDA Adverse Event
    GENENTECH, INC.·Product code KZE·November 9, 2009

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·February 12, 2021

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 27, 2017

    DURAFLEX DURAL GRAFT

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL, GMBH·Product code GXQ·October 25, 2023

    DURAFLEX DURAL GRAFT

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL, GMBH·Product code GXQ·October 25, 2023

    PICC DRESSING CHANGE TRAY

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES INC.·Product code OXQ·July 14, 2021

    DURAFLEX DURAL GRAFT

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL, GMBH·Product code GXQ·October 26, 2023

    Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1529100***Thermasplint Kit, Small***X5***. ***REF 1529110***Thermasplint Kit, Medium***X5***. ***REF 1529120***Thermasplint Kit, Large***X5***. RECALLED PRODUCT - Front: ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code EPP·February 21, 2011

    An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1528116***External Nasal Splint Kit, Small***X5***. ***REF 1528126***External Nasal Splint Kit, Medium***X5***. ***REF 1528136***External Nasal Splint Kit, Large***X5***. RECALLED PRODUCT - Front: ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.*** Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code EPP·February 21, 2011