BEUDAMED
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    LEDEX

    FDA 510(k)
    FDA Class 2 ·Dental

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925028203·MINI-MCGEE CUPPED FORCEPS

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093624·

    Zavation

    FDA UDI
    Zavation LLC·00842166176614·Rod Introducer

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450189177·

    Fine osteotomy Locking HA 4.5 Cortical Bone Screw - L42mm

    FDA UDI
    Laboratoires Bodycad Inc·00688346002775·Button Head Locking HA 4.5 Cortical Self Tappin...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166527·Initia T3 Acetabular Hemispherical Shell, Multi...

    BLADEVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATAC HEMOGLOBIN A1C REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    NUVASIVE GENERAL INSTRUMENTS

    FDA Adverse Event
    Injury ·NUVASIVE, INC.·Product code LXH·April 12, 2024

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 21, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 20, 2008

    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    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