BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Glidewell TuffSplint™ Appliance Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024040045·

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ARTICUL/EZE BALL 28 +1.5 GR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 19, 2014

    HUT EXT DR FINAL ASSY, RE , FDP

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM COMPANY·Product code MQB·August 5, 2014

    ACTIVA RC

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·August 18, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·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