BEUDAMED
    19 results · 34ms · Sources: EU EUDAMED, US FDA

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    BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776380557·24/26fr 360° Rotatable Continuous Flow Sheath, ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694031400·1.6mm Buttress Plate, Right, Modified

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776127251·24Fr Inner Sheath

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450188965·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450541708·

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00840326401958·Carbide Bur Taper

    TISSUE FORCEPS POTTS-SMITH-7"-SERRATED

    FDA UDI
    W.H. Holden, Inc.·D9281300650·

    Momentum

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386025645·Tap, Ø 6.5mm, non-cannulated, 1/4"-square

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315056949·

    SPAULDING IQ ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAKO NEFA LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    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

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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