BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CSNP-001A NEURO PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IBP ELBOW INTERLOK FINISH ULNAR COMPONENT STANDARD LEFT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDB·June 14, 2017

    UNKNOWN KUDO ELBOW

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDB·February 9, 2017

    UNKNOWN KUDO ELBOW

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDB·March 2, 2017

    UNKNOWN KUDO ELBOW

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDB·February 9, 2017

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·February 21, 2013

    BBRAUN STIFFEN MICRO-INTRODUCER KIT

    FDA Adverse Event
    Other ·BBRAUN·Product code BSR·January 21, 2011

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPP·August 1, 2014

    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