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

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    Televere Podiatry Digital Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES

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

    DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 18 G X 1.16 IN.

    FDA Adverse Event
    Injury ·BD (SUZHOU)·Product code FOZ·April 18, 2017

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 11, 2013

    COULTER LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 15, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 18, 2008

    PENUMBRA COIL 400

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·November 29, 2016

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024