BEUDAMED
    15 results · 23ms · 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 ×

    NAUTILUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ ST 98x12 ML D2

    FDA UDI
    ARGEN CORPORATION, THE·D818123373·Dental porcelain/ceramic restoration kit

    SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

    FDA 510(k)
    FDA Class 1 ·Radiology

    QUANTA SYSTEM S. P. A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 9, 2014

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 10, 2011

    UNK HIP FEMORAL STEM CORAIL

    FDA Adverse Event
    Malfunction ·DEPUY IRELAND·Product code LZO·March 10, 2026

    UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code LZO·March 10, 2026

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 10, 2026

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024