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

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    MRSA/SA ELITE MGB

    FDA 510(k)
    FDA Class 2 ·Microbiology

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750007028·8300C PNT/HTRSHELL/CONN ASSY

    KNEE MODULE FOR THE STEALTHSTATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSTEOPHIL BETA-TCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO, INC.·Product code GCJ·May 25, 2011

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    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