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

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    MEDIGROUP KEY TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Diamond D

    FDA UDI
    Keystone Industries·H66810130171·Denture Acrylic SC Liquid

    Zavation

    FDA UDI
    Zavation LLC·00842166114838·TLIF 30, 6deg -17

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130070·Rocker, One Piece

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710640130170·3rd TMT Joint Cut Guide, 13mm x 17mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710630130170·2nd TMT Joint Cut Guide, 13mm x 17mm

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 14, 2017

    AV 800 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GRAMSORB SYNTHETIC ABSORBABLE SUTURE

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

    NITINOL TC ELECTRODE 10CM

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·August 29, 2018

    APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·March 20, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    ILS 29MM CURVED

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2014

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 14, 2017

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014