BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    VEGA ULTRASONIC NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 25, 2022

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506062063·BOWEL SIZER; 31MM

    STAR™

    FDA UDI
    Stryker GmbH·00886385019451·Trial S.T.A.R. P.E. Core 11mm

    STAT-SHELL DISPOSABLE SP02 SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEEDLELESS TRANSFER DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·February 21, 2023

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS LLC (PR)·Product code NIQ·February 28, 2011

    COVIDIEN/KENDALL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·February 21, 2008

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·September 30, 2020

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024