BEUDAMED
    43 results · 8ms · Sources: EU EUDAMED, US FDA

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    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·September 10, 2025

    WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·September 10, 2025

    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·September 10, 2025

    WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·September 10, 2025

    Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·October 15, 2025

    Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·October 29, 2025

    Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·August 6, 2025

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016

    AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016