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

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    Akunah REFLECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·November 9, 2006

    STEALTH 360 ORBITAL PAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMP,TSV,3.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 22, 2021

    IMP,TSV,3.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 17, 2021

    PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·August 17, 2011

    ZEPHYR XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 17, 2024

    LEEP PRECISION GENERATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·March 16, 2020

    SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012

    LEEP PRECISION GENERATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·July 1, 2025

    SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·September 6, 2012

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018