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

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    Passeo-18 Peripheral Dilation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASSEO-18 5/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 6/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 2.5/170/130

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

    MaxFuse,VBR, 12 (D) x 14 (W) x 28 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468056186·VBR, 12 (D) x 14 (W) x 28 (H)

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 21, 2024

    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE

    FDA 510(k)
    FDA Unclassified ·Unknown

    THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    CAPSURE EPI

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·June 7, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023