BEUDAMED
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    RENEGADE STC 18 MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Responder Pro AED Battery

    FDA UDI
    Cardiac Science Corporation·00812394020423·IntelliSense lithium battery: For Responder Pro...

    6MM BD¿ INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 12, 2017

    EBI OMEGA21 SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIO-LOGIC SLEEPSCAN NETLINK

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALARIS¿ GP SERIES PRIMARY INFUSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 13, 2023

    ZYPLAST COLLAGEN IMPLANT

    FDA Adverse Event
    Injury ·COLLAGEN CORP.·Product code LMH·November 19, 1998

    CODMAN DISPOSABLE PERFORATOR

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code HBF·March 27, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 1, 2014

    LIFESHIELD CONV SOLUSET

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·April 1, 2008

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 10, 2018

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 10, 2018

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 22, 2018

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 21, 2018

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018