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

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    NONABSORBABLE NYLON SURGICAL SUTURE*

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00887517386526·Universal Extractor, 3.5mm Tap

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861029217·3M™ Unitek™ Stainless Steel Permanent First Bic...

    CRANEX 3D

    FDA UDI
    PaloDEx Group Oy·06430035872190·

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981129026·Tab Remover

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531101·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531601·IN-OVATION® C Roncone 018 U5-5/L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531111·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531001·IN-OVATION® C Base Rx 018 U5-5/L3-3

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531611·IN-OVATION® C Roncone 018 U5-5/L3-3 CS-BC HK

    RADCALC SOFTWARE, VERSION 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    VISCOPE, MODEL 100P,100S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·June 27, 2014

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·January 7, 2013

    NOVAMAX LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP·Product code NBW·October 29, 2010

    CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LPN·June 23, 2022

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 28, 2023

    CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014