BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    HERPES GROUP IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033059·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl D...

    SlimLine®

    FDA UDI
    ZIMMER SPINE, INC.·00889024403697·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319735077·Skeele Chalazion Curette, round cup 2.5 mm, ser...

    LASER 4SPSC340

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 25, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·April 23, 2008

    BD STERILE SYRINGE CONVENIENCE TRAYS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 1, 2023

    ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·June 17, 2020

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013