BEUDAMED
    27 results · 26ms · Sources: EU EUDAMED, US FDA

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    A-GENT QUANTICHROM THROMBIGEN I

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACUMED

    FDA UDI
    Acumed LLC·10806378044281·Fragment Reduction Tool

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867042513·3 HOLE DBL COMP PLATE, 25MM

    Endo-Model Saddle Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575047833·Base components with inside anti-rotation pin, ...

    HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Citregen Tendon Interference Screw and Citrelock

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    Product: STA Liatest D-Di; REF: 00515;

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025

    Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code KFF·July 18, 2014

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JPA·June 15, 2012

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJT·January 28, 2013

    STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023

    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023

    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023