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

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    ANTIHUMAN IGG GLOBULIN FITC LABELED

    FDA 510(k)
    FDA Class 2 ·Immunology

    PreView™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210180·PreView All-in-One Guide-Cervical

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707034047·.018 Lower Stainless Steel Resilient Internatio...

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690115427·Retaining Bolt PS or PS-C Insert, Modular Tibia...

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651445831·MIC* Gastro-Enteric Feeding Tube with ENFit® Co...

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00350770445830·MIC* Gastro-Enteric Feeding Tube with ENFit® Co...

    BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRUETEST

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·July 27, 2021

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 7, 2014

    REPLY

    FDA Adverse Event
    Injury ·SORIN CRM S.R.L.·Product code NVZ·October 26, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 27, 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

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012