BEUDAMED
    9 results · 19ms · 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 ×

    HOPKINS Telescopes

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Ryno Lacer Wrist and Thumb Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357238859·

    COMBI-SCREEN, MODELS 10SL AND 11SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    ZEPHYR XL DR

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

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC TIJUANA·Product code LOX·August 18, 2011

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 2, 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