BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 14, 2020

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·November 18, 2014

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·May 14, 2015

    LOGIC FEMORAL PS POR RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·March 19, 2015

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 22, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

    LOGIC CR FEMORAL POR, RIGHT, SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 14, 2019

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·June 5, 2015

    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 Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025