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

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    EMPOWR™ blade stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pressure Sentinel® Intramedullary Reaming System

    FDA UDI
    Zimmer, Inc.·00889024039988·

    RSV OIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Symmetric Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    NEXTAR SPINE

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

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

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 10, 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