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

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    Arthrex SynergyID Endoscopic Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CG+ ARROW PICC POWERED BY ARROW VPS STYLET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    ITOTAL G2

    FDA Adverse Event
    Injury ·CONFORMIS·Product code JWH·October 30, 2014

    WAVELIGHT EX500 EXCIMER LASER

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·July 10, 2013

    NEXTAR SPINE

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

    ARCOS CON SZ D HI 80MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 23, 2019

    ARCOS 20X190MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 22, 2019

    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