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

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    SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FLOWREST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CERAMENT BONE VOID FILLER, MODEL A0210

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERIPHERAL NERVE BLOCK SUPPORT TRAY

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC·Product code CAZ·October 1, 2014

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 28, 2018

    VANGUARD COMPLETE KNEE SYSTEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HRY·October 15, 2014

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013

    CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code CAZ·October 2, 2014

    CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code CAZ·October 3, 2014

    CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code CAZ·October 1, 2014

    PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code CAZ·May 12, 2015

    CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH - IRVINE·Product code CAZ·November 8, 2015

    CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code CAZ·July 1, 2015

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU

    FDA Adverse Event
    Malfunction ·HALYARD·Product code CAZ·April 7, 2015

    ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU

    FDA Adverse Event
    Malfunction ·HALYARD·Product code CAZ·April 7, 2015

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018