BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V

    Trial Cups

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038960·

    SNORERX 9.0

    FDA 510(k)
    FDA Class 2 ·Dental

    CAPIOX AF125X ARTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 22, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code DTB·January 13, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011

    VERSACARE

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

    Banana Peel™ Sheaths - 9/45 Catalog Number: 260300

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

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

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

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014