BEUDAMED
    83 results · 24ms · Sources: EU EUDAMED, US FDA

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    Aquilion Prime SP, TSX-303B/1, v8.4

    FDA 510(k)
    FDA Class 2 ·Radiology

    PIEZOTOME SOLO

    FDA 510(k)
    FDA Class 2 ·Dental

    CYBOW READER, MODELS 300 & 720

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

    U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013

    MAXFIRE W/ZIPLOOP

    FDA Adverse Event
    Malfunction ·BIOMET SPORTS MEDICINE, INC.·Product code JDR·July 22, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 18, 2008

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 29, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 27, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 1, 2021

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 4, 2022

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KNS·July 19, 2021

    FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·January 11, 2021

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 29, 2021