BEUDAMED
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    PRENATAL SUPPORT PILLOW

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Keystone Industries

    FDA UDI
    Keystone Industries·H66818100351·Pk/10 Strength Braid Ss

    Lab

    FDA UDI
    STERNGOLD DENTAL LLC·00841549115868·Lab Burnout Post Starter Kit

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

    IdentiTi II

    FDA UDI
    ALPHATEC SPINE, INC.·00190376662312·ALIF SA ANGLED SCREW REMOVAL DRIVER, 35°

    INDIKO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IVS TUNNELLER

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

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 31, 2012

    31G X 8MM PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMI·August 12, 2010

    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·February 11, 2026

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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