BEUDAMED
    16 results · 7ms · Sources: EU EUDAMED, US FDA

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

    Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 10, 2024

    GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·December 23, 2020

    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    FDA Enforcement
    Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024

    GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026