BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    Female Luer Lock Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006628·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 5.0mm

    Intraoral Scan Body EV/5.4

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075052·

    Instrument Tray

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224864·Instrument Tray

    RAGNELL SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083721·RAGNELL SCISSORS FLAT CURVED TIP POWER CUT GOLD

    HASKAL TORQUE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD LOGIC CO-BRANDED BLOOD GLUCOSE METER

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code CFR·October 17, 2003

    ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·January 3, 2005

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·February 24, 2017

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MARINR

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code LPB·August 21, 2017

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Kit BD Max GC RT PCR Assay; Catalog # 443486

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    CAPSURE EPICARDIAL LEAD

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code NVN·October 18, 2022

    CAPSURE EPICARDIAL LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·October 18, 2022

    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