BEUDAMED
    1,034 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    IgE Calibrator Series

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DGC·September 7, 2016

    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code DAP·December 3, 2004

    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DGC·March 5, 2018

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

    Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·April 3, 2006

    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.

    FDA Recall
    Terminated ·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009

    DiaSorin Analyte Specific Reagent

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DGK·January 18, 2005

    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code DAP·April 17, 2013

    D-Dimer Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DAP·November 3, 2025

    VIDAS DEX@, Dimer Exclusion II, REF 30455-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code DAP·September 22, 2021

    Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·April 3, 2006

    Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DAP·July 29, 2005

    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DAP·November 11, 2015

    Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

    FDA classification
    FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma