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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564033147·Towel, 5-Pack

    MULTI-STRAP FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LOGIC FEMORAL PS POR RIGHT SZ 2

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

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 10, 2011

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·EBI, L.P.·Product code KWQ·August 20, 2008

    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

    BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    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