BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 14, 2024

    SYRINGE 50ML LL PRECISE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·October 27, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    ENDOSTITCH SURGIDAC

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SURGICAL·Product code KOG·May 22, 2013

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·June 27, 2011

    ATK TURBOHAWK CALCIUM

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code MCW·April 20, 2017

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·April 20, 2017

    PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD

    FDA Adverse Event
    Injury ·COVIDIEN·Product code NIO·April 20, 2017

    PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024