BEUDAMED
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    Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Surgical Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACTIVE FIXATION ENDOCARDIAL LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    CXDI CCS NE VER.2.02.0.16

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·June 28, 2013

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·August 18, 2011

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026