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

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    Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362616·Integra® Miltex® Castroviejo Needle Holder, 5-1...

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704512984·

    SignaLoc Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215116941·

    31G X 8MM 1/2CC WALGREENS INSULIN SYRINGE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMF·September 22, 2011

    ENSPLINTCMX CLAVICLE PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

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

    31 G X 8 MM 1/2 CC WALGREENS INSULIN SYRINGE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMF·October 31, 2011

    MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2019

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    LAGUNA PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·PHYGEN, LLC·Product code MNH·June 14, 2013

    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