BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    DSI Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123084·Wire, Guide 1.8x200mm Sgl Trocar

    ESMARCH HEAVY BANDAGE SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054417·ESMARCH HEAVY BANDAGE SCISSORS POWER CUT GOLD

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114131·BIMANUAL IRRIGATION 21GA END OPEN PK/10

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307430·STDHO LINER 40-72/74

    BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    g.Estim FES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CADD-SOLIS VIP AMBULATORY

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·January 5, 2022

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 4, 2017

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 1, 2016

    FLEXICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 10, 2011

    UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·September 24, 2008

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 1, 2013

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 28, 2023

    EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·July 10, 2024

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014