BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Digital Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DUVAL COLLIN FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084919·DEBAKEY COLLIN FORCEPS DOUBLE DEBAKEY TIP

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108707·5 MM DIA., 33 CM BIPOLAR DUAL NEEDLE MYOMA COAG...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026369·Drill Guide, Neutral, Short

    MTP CLEARVISION DISPOSABLE TUBING SET

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VITALOGRAPH BASE STATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARCHITECT I1000SR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 16, 2022

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    ARCHITECT I1000SR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 5, 2022

    ARCHITECT I1000SR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 19, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    REVEAL XT

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

    LCS COMP VVC INS STD+ 10MM

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NJL·November 4, 2015

    ARCHITECT I1000SR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 19, 2023

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 23, 2019

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 16, 2019

    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