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

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    FDA 510(k)
    FDA Class 2 ·Immunology

    ZESPIN SI Joint Fusion System

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

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357239214·

    BODYTRONIC 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JET-X HA COATED HALF PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TANGO OPTIMO

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSITCS GMBH·Product code KSZ·April 14, 2011

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 5, 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