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

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    Little Wave Clik, Rogue XP, Little Wave XP, Spark

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ZESPIN SI Joint Fusion System

    FDA UDI
    Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

    ENDER NAIL

    FDA UDI
    Smith & Nephew, Inc.·03596010104397·3.5MM DIAMETER NAIL 3.5MMX27CM ...

    IMP,TSV,4.1MM,SBM,13

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 25, 2022

    AIRLIFE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RIATA ACTIVE FIXATION

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

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 15, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 12, 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