BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    JAZZY ELITE 6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750002962·76 V2 ASSY EXSMALL 22OD W/HG

    Arx

    FDA UDI
    Life Spine, Inc.·00190837035495·Arx A/O Hexalobe Driver

    CONCORDE BULLET CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

    FDA 510(k)
    FDA Class 2 ·Neurology

    R3 XLPE INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 24, 2014

    PENTA 3MM LEAD, 60 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 31, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    ACCOLADE DR EL MRI (Model L331)

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