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

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    HL168T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092117699·3i External Hex Titanium Screw

    Mariner MIS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981171438·MIS Tap A/O, Dia 7.50mm

    HammerTube System

    FDA UDI
    Paragon 28, Inc.·00889795039354·Implant Inserter, 2.75mm

    Autolith Touch

    FDA UDI
    NORTHGATE TECHNOLOGIES INC.·00817183020493·Lithotripter, Biliary, BSC

    MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP2 TEST- SCL-70

    FDA 510(k)
    FDA Class 2 ·Immunology

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

    MITEK UNKNOWN INTRAFIX

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·March 13, 2013

    PINN CAN BONE SCREW 6.5MMX35MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NDJ·February 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 26, 2008

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

    FDA Enforcement
    Class II ·Terminated·Zipline Medical·March 11, 2015

    DISP.TROCAR THRD.W.DILATING PIN 12/110MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GCJ·July 9, 2019

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013