BEUDAMED
    24 results · 21ms · Sources: EU EUDAMED, US FDA

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    Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·14026704734341·RUSCH POLARIS FO BLADE WIS-HIPPLE 1

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918179452·Sustainable Surgical Sponge Bowl_1500cc_Non-ste...

    Malibu™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981030148·PRECONTOURED ESS ROD, 5.5 x 500 mm

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088323·

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·October 15, 2022

    Phantom Hindfoot TTC/TC Nail System

    FDA UDI
    Paragon 28, Inc.·00889795097620·Phantom TC Nail, 11.5 X 150mm

    Smart Correction

    FDA UDI
    Wishbone Medical, Inc.·B5621070211515000·Dual Joint Express Strut, Short, Non-Sterile

    FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A

    FDA 510(k)
    FDA Class 2 ·Radiology

    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    MICRO INFILTRATION MULTI-HOLE 6

    FDA UDI
    The Wells Johnson Company·B458201515000·Cannula, Micro Infiltration Multi-Hole 6, on dl...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707097983·TITANIUM WIRE D1,5 L150MM

    II Ring Retractor

    FDA UDI
    Automated Medical Products Corp.·00810118341359·Malleable Retractor 2" x 6" with Protective Edge

    VACUTRON

    FDA UDI
    Allied Medical, LLC·00026072008331·CONTINUOUS INTERMITTENT SUCTION REGULATORS

    INSYTE - W 20 GA 1 1/4 IN

    FDA Adverse Event
    Injury ·BECTON DICKINSON & CO.·Product code FOZ·July 12, 1996

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    VEST, MODEL 105

    FDA Adverse Event
    Injury ·HILL-ROM SERVICES PRIVATE LIMITED·Product code BYI·June 23, 2011

    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

    FDA Enforcement
    Class II ·Ongoing·Wishbone Medical, Inc.·February 15, 2023