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

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    A-GENT CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dealmed

    FDA UDI
    Leonhard Lang GmbH·19005531002194·Resting ECG electrode

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111295737·JACKSON TUBE IMPR. #5 STL

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515203457·Excavator & Probe, 6" D/E

    PATIENT HEATER SYSTEM, MODEL PH112

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Piccolo Composite® Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 30, 2014

    SKIL-CARE CORPORATION

    FDA Adverse Event
    Other ·SKIL-CARE CORP.·Product code KNN·September 24, 2012

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code LZG·May 19, 2015

    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 7, 2023

    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·March 21, 2023

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021