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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ORAcollect.Dx

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    K152468

    FDA UDI
    Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

    Low Profile Acetabular Reamer 64

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057664·

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 19, 2025

    QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

    QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    OXYGENRATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 7, 2013

    NDEHP 2CLV YSTE MACR

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·June 27, 2011

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 21, 2021

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023