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

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    OPENING/CLOSING WEDGE OSTETOMY PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567357·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567340·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567388·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361015901·Quad Thread Cannulated 5.5x55

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567371·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567364·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567395·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033567333·

    NA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197026680·Standard Operating Scissors Fig. 3 straig...

    INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    VERITY ADX SR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

    VICRYL POLYGLACTIN 910 SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 21, 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