BEUDAMED
    62 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Atellica IM 1600 Analyzer, SMN 11066000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·October 27, 2021

    Atellica IM 1300 Analyzer, SMN 11066001

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·October 27, 2021

    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·March 15, 2023

    B125P Patient Monitor (with E-module slot option), REF 6160000-002

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·March 15, 2023

    B125M Patient Monitor, REF 6160000-004-XXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    B105M Patient Monitor, REF 6160000-003

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·March 15, 2023

    Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA

    FDA Enforcement
    Class II ·Ongoing·Microcare Medical·October 2, 2024

    Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

    FDA Enforcement
    Class II ·Ongoing·Edwards Lifesciences, LLC·April 6, 2022

    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·March 23, 2022

    Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·March 4, 2026

    medex Arterial Kit 1/EA, Product Code REF MX7827

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024