BEUDAMED
    18 results · 32ms · Sources: EU EUDAMED, US FDA

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    ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX

    FDA 510(k)
    FDA Class 2 ·Dental

    TruLock

    FDA UDI
    Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...

    BD INTIMA-II¿ PRN Y ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 19, 2023

    ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS

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

    MODEL 455GE PHASED ARRAY WRIST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 4, 2025

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 22, 2009

    BD INTIMA-II¿ PRN Y ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 19, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Other ·INO THERAPEUTICS LLC/IKARIA·Product code MRN·July 15, 2008

    BD INTIMA-II Y 22GAX1.00IN

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 1, 2023

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 10, 2018

    GUARDIAN ANDROID¿ APP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·May 1, 2024

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 1, 2023

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018