BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    ICONIX ALL SUTURE ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE BIOABSORBABLE MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GENESYS SPINE TILOCK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018

    BMT 360 TIB TRAY 75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 1, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·May 20, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN - BENNETT CORP.·Product code CBK·August 20, 2008

    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

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

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

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025