BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Low Profile Companion Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITALCARE URETHRAL CATHETER RED RUBBER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ComPAS2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·April 30, 2013

    TENDRIL ST

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

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 18, 2011

    GROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) S

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·July 10, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

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

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