BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    PRO Plating System, Stryker Trauma Pelvic Set (Matta)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Omnipod 5 SmartBolus Calculator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    RIATA ACTIVE FIXATION

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

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 25, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 12, 2013

    BIOLOX DELTA CER FEM HD 32/+3MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 27, 2025

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    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