BEUDAMED
    365 results · 24ms · Sources: EU EUDAMED, US FDA

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    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·September 10, 2025

    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·May 6, 2026

    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·December 10, 2025

    Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc·January 21, 2026

    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·July 30, 2025

    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·July 23, 2025

    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·July 30, 2025

    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·July 23, 2025

    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·September 25, 2024

    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024