BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867522626·Cannulated Canc Screw, FT, 7.0x80mm

    AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 80mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010275·

    SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BEHRING COAGULATION SYSTEM, MODEL BCS

    FDA 510(k)
    FDA Class 2 ·Hematology

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    ASSURANT COBALT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIO·April 9, 2013

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 31, 2011

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    INTERSTIM

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code EZW·February 21, 2020

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·January 6, 2022

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 1, 2021

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·January 6, 2022

    PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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