BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CD Horizon Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLEA

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

    NELLCOR INDGO MANUAL RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BARRIER EASYWARM

    FDA Adverse Event
    Injury ·MOLNLYCKE HEALTHCARE·Product code KGO·October 29, 2014

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 22, 2011

    COMP RVS HMRL TI TRAY 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·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