BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    SR-8100 Portable X-ray Unit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142006370·CC-417

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925047327·ES-IP iOR Danderyd Small (no rack)

    SPATULA OSTEOTOME 7MM

    FDA UDI
    W.H. Holden, Inc.·D9282006370·

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120063700000·Right X-Ray Marker

    CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SELECT STIM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTRATHECAL CATHETER

    FDA Adverse Event
    Other ·RICE CREEK MANUFACTURING·Product code LKK·June 4, 2007

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·February 1, 2016

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDG·October 24, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·February 1, 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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018