BEUDAMED
    19 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 9, 2016

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

    FDA Enforcement
    Class II ·Terminated·Sysmex America Inc·September 21, 2016

    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 25, 2015

    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 1, 2017

    Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 28, 2019

    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·February 1, 2017

    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·February 1, 2017

    INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 10, 2016