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

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    Three Way Stop Cock

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 22, 2023

    AEROPILOT

    FDA 510(k)
    FDA Class 2 ·Radiology

    GOLD CORE PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    ICHEM VELOCITY

    FDA Adverse Event
    Injury ·IRIS INTERNATIONAL·Product code KQO·October 29, 2014

    MAQUET OPERATING TABLE SYSTEM TRANSPORTER

    FDA Adverse Event
    Malfunction ·MAQUET GMBH & CO. KG·Product code FPO·June 14, 2011

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 12, 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