BEUDAMED
    39 results · 14ms · Sources: EU EUDAMED, US FDA

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    Cios care fusion system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    Cios care fusion system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DAP·May 22, 2012

    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DAP·June 7, 2012

    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

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

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

    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

    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

    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·July 6, 2022

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·April 15, 2020

    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ¿M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.

    FDA Enforcement
    Class II ·Terminated·Accriva Diagnostics, Inc.·June 1, 2022

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code GAD·November 28, 2019

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·March 27, 2019

    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, INC·February 21, 2018