BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MD-2300S Ultrasonic A/B Scanner for Ophthalmology

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169501850·INTERBODY 2152318 LARGE - 12 DEG 18MM

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055226·

    Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLEARPATH 24

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LACTOSORB TRAUMA PLATING SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·July 24, 2017

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 7, 2013

    PUREPOINT

    FDA Adverse Event
    Malfunction ·ALCON-IRVINE TECHNOLOGY CTR·Product code HQF·October 2, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011

    ULTRAFLEX DUO HIGH FLUID CART

    FDA Adverse Event
    Malfunction ·DORNOCH·Product code JCX·August 28, 2017

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024