BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    NON-CONDUCTIVE, SINGLE USE FACE MASK #55

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208012510·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00148012510·2G Wide VS4

    BD PLASTIPAK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 20, 2019

    SNIPER, MODEL OR-3872XX SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO AESKULISA DS DNA G

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 8, 2014

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·October 23, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015

    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025