BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Wearable Breast Pump (Model S18)

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

    Wrist and Thumb SupportRyno Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357238866·

    ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BriefCase

    FDA 510(k)
    FDA Class 2 ·Radiology

    IDENTITY SR

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

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012