BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    SLENDERTONE FLEX MAX, MODEL 517 US

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Comfort Soft Plus

    FDA UDI
    WESTMED, INC.·00709078014185·Oxygen Cannula Adult Soft Prongs W/7' Kink Resi...

    Procure

    FDA UDI
    Twin Med, LLC·10840330700075·Oxygen Cannula Adult Soft Prongs W/7' Kink Resi...

    HS Dia.Burr,coarse,Ø5.0x70,50k

    FDA UDI
    Bien-Air Surgery SA·07630055506979·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    MEDCOM RT-VIEWER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Death ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 8, 2013

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·May 17, 2011

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    MicroAire K-Wires

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·March 15, 2017

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020