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

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    CALCIGEN-S BONE VOID FILER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NVM5

    FDA UDI
    Nuvasive, Inc.·00887517071613·NVM5 Cable, Gray Anode

    Natus

    FDA UDI
    XLTEK·00382830016452·Natus Base DC Input Y Cable

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450635926·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033544815·

    DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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

    CORTISOL LIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·June 10, 2023

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 10, 2011

    EASY LOAD INSERTER

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·March 14, 2008

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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