BEUDAMED
    17 results · 29ms · 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 ×

    ANTRUM & ATTIC MIRROR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LABONE MICRO-PLATE COTININE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 27, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012

    2 GALLON SHARPS CONTAINER

    FDA Adverse Event
    Injury ·MEDEGEN·Product code MMK·September 7, 2010

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016

    RP FLEX W SMART ASSIST SET, US

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code PYX·February 21, 2026

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code KNT·June 12, 2024

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018