BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026223·microSelectron Transfer Tube for 5F Flexibles (21)

    FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEJET PRINTER 400

    FDA 510(k)
    FDA Class 2 ·Radiology

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 6, 2013

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 13, 2011

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR SWITZERLAND·Product code FGE·August 13, 2008

    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022