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

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    Filters Regulation: Us FDA ×

    KardiaAI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SignaLoc Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215116927·

    ARTHREX SWIVELOCK ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MASTERSCREEN PAED - BABY BODY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 21, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 28, 2011

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025

    MOZECTM NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·October 21, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021

    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