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

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    ChoiceSpine Blackhawk Ti Cervical Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    'RAPIDTEC'-5M-MULTIPLE DIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    ZEPHYR XL DR

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

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 18, 2011

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·July 10, 2013

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    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