BEUDAMED
    21 results · 30ms · Sources: EU EUDAMED, US FDA

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    CMC CABLE FIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721110320·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1672111032060·

    16PW - ACCO

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588110325·16PW - ACCO

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015159·microSelectron Transfer Tube for 6F Flexible (1)

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809265158875·

    SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 3, 2014

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 4, 2022

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 9, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011

    PUREVISION TORIC (BALAFILCON A) CONTACT LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code LPM·August 12, 2008

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·July 5, 2023

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 10, 2026

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 26, 2022

    AXIUM

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·February 26, 2022

    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