BEUDAMED
    16 results · 21ms · 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 ×

    Z5-BL

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)

    TMC PSI Cut Guide System

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224680·Cut Guide

    INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

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

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 29, 2017

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code GKZ·October 15, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 11, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·April 6, 2018

    BD SYRINGE 5ML LL EURO 125 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 9, 2019

    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012