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

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    SpeedLock Knotless Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zavation

    FDA UDI
    Zavation LLC·00842166177437·Z-Link Lumbar Sizer 15 deg, 33mm x 13

    Zavation

    FDA UDI
    Zavation LLC·00842166112414·Z-Link Lumbar Spacer 15eg 33mmx13

    MOLECULAR ADSORBENT RECIRCULATING(MARS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    150 FASTURN SYRINGE KIT W/QFT

    FDA Adverse Event
    Malfunction ·BAYER MEDICAL CARE, INC·Product code DXT·March 24, 2014

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/12 MM RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 25, 2017

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    MEMBRAGEL

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·September 10, 2008

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    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