BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587T1110340·11mm TLIF Implant 10mm Wide 34mm Length

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809265158899·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015173·microSelectron Transfer Tube for 6F Flexibles (3)

    NIOX MINO MODEL 09-1000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 14, 2013

    CLIP SLING

    FDA Adverse Event
    Malfunction ·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·April 21, 2011

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 12, 2008

    BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 4, 2022

    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

    FDA Enforcement
    Class II ·Terminated·Integrated Science Systems Inc·June 15, 2016

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024