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

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    FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109880·Zirlux Titanium Esthetic Abutment Posterior com...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756181006·EXTREMITY FOOT TRAY

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL SA·Product code MOQ·August 5, 2021

    REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODULAR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 7, 2025

    30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 7, 2019

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    ENDOSCOPIC BILIARY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQR·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016

    25 G X 5/8 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 24, 2017

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024