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

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    INTRA-LOCK DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INPECTRA STO2 SPOT CHECK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 29, 2013

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·June 16, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 3, 2016

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·August 26, 2016

    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