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

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    Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026116·2.0mm Locking Drill Guide CMF

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319742839·Jansen-Middleton Septum Forceps 6-3/4" (17.2cm)...

    ACUMED

    FDA UDI
    Acumed LLC·10806378014482·2.7mm x 14.0mm Locking Cortical Screw

    ACUMED

    FDA UDI
    Acumed LLC·10806378014499·2.7mm x 14.0mm Locking Cortical Screw

    MEDVIZER PACS, MODEL RELEASE 2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

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

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·August 20, 2014

    SPINAL CORD STIMULATION DEVICES

    FDA Adverse Event
    Other ·MEDTRONIC NEUROMODULATION·Product code GZB·September 21, 2007

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Death ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·August 22, 2008

    DEEP BRAIN STIMULATION DEVICES

    FDA Adverse Event
    MEDTRONIC NEUROMODULATION·Product code MHY·September 21, 2007

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

    MECTALIF TRANSFORAMINAL CAGES TIPEEK

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

    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