BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

    FDA 510(k)
    FDA Class 2 ·Neurology

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357235520·

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105473·GLOBAL C.A.P. CTA CTA HEAD TRIAL 52 x 18

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105480·GLOBAL C.A.P. CTA CTA HEAD TRIAL 52 x 21

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105497·GLOBAL C.A.P. CTA CUTTING BLOCK SIZE 52

    Rapid Reboot

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INSTINCT JAVA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REALIZE ADJ GASTRIC BAND STR

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·August 25, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 4, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 12, 2013

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    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