BEUDAMED
    16 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 ×

    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890113470·Zirlux Titanium Screw compatible with: Strauman...

    LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MERIDIAN-II AND MERDIAN-PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018

    1719045-2013-00644

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·March 19, 2013

    SIGMA PS CEM FEM SZ2.5 R

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·March 4, 2011

    INCOMPASS

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code KWP·March 11, 2008

    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

    3.5MM TI LOCKING SCREW SELF-TAPPING 55MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code KTT·September 15, 2015

    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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024