BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trulife

    FDA UDI
    Trulife Limited·00645517726755·First Fit External Breast Form Size 10

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600100·Tray Insert, Trials

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0600100·Tray Insert, ISP Instrument Prep

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600100·Tray Insert, Lumbar Instruments, 2

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0107100·Tamp, Rotating

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023796·Angled Tamp

    MD 10, SEM, SM 12, CBM

    FDA 510(k)
    FDA Class 1 ·Dental

    SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES

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

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862284822·LOGIC CC FEM BOX TRIAL SIZE 1 RIGHT

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862626011·TRULIANT CC MODULAR FEMORAL BOX TRIAL SIZE 1 RIGHT

    UNKNOWN NOTTINGHAM SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBF·May 17, 2017

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·April 5, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011

    CALAXO UNKNOWN SCREW SIZE

    FDA Adverse Event
    Other ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·June 12, 2008

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024