BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    THE DOME S6C

    FDA 510(k)
    FDA Class 2 ·Radiology

    Zavation

    FDA UDI
    Zavation LLC·00197157005429·Trial Drill Guide 12x14x9

    NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MERIT HYDROPHILIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERCUFLEX? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FGE·May 29, 2013

    UNK

    FDA Adverse Event
    Injury ·COOPERVISION, INC.·Product code LPL·June 16, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·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

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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