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

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    AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902163883·CYLN ENDO 20MM BASE CASE

    SYRINGE 0.3ML 30GA 1/2IN UF

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 14, 2020

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 24, 2019

    INFINION 16

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 3, 2021

    REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HI-DOW-XP

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 14, 2013

    DUROM ACETABULAR COMPONENT 52/46 L

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·September 10, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 3, 2011

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025