BEUDAMED
    23 results · 15ms · Sources: EU EUDAMED, US FDA

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    Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

    FDA Enforcement
    Class II ·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022

    Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16

    FDA Enforcement
    Class I ·Ongoing·ZOLL Medical Corporation·June 26, 2024

    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.

    FDA Enforcement
    Class III ·Terminated·HemoCue AB·January 9, 2013