BEUDAMED
    6 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0MMX120MMLG CANN BONE SCREW 7.0X125LG CANN BONE SCREW 7.0MMX125MMLG CANN BONE SCREW 7.0X130LG CANN BONE SCREW 7.0MMX130MMLG RECON SCR LGE 5.5MMDX105MM RECON SCR LGE 5.5MMDX110MM RECON SCR LGE 5.5MMDX115MM RECON SCR LGE 5.5MMDX120MM RECON SCR LGE 5.5MMDX125MM RECON SCR LGE 5.5MMDX130MM ITST ANTI-ROT SCR 6.5MMDX105MM ITST ANTI-ROT SCR 6.5MMDX110MM PERI. SCR 3.5MM X105MML PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 140MM L PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 100MM L 3.5MM CORT SCR X 105MM SELFTAP 3.5MM CORT SCR X 110MM SELFTAP 5.5MM X 100MM CANN LKNG SCREW Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115 CANC SCREW FA Z NAIL 6.0 X 120 CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115CANC SCREW FA Z NAIL 6.0 X 120CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA 3.5X105 CORT SCR 3.5 X 105 CORT SCR SELF TAP 3.5X110 CORT SCR 3.5 X 110 CORT SCR SELF TAP 3.5X115 CORT SCR 3.5 X 115 CORT SCR SELF TAP 3.5X120 CORT SCR 3.5 X 120 CORT SCR SELF TAP 3.5X125 CORT SCR 3.5X130 CORT SCR 3.5X135 CORT SCR 3.5X140 CORT SCR 3.5X145 CORT SCR 3.5X150 CORT SCR 4.5 X 105 CORT SCR SELF TAP 4.5 X 110 CORT SCR SELF TAP 4.5 X 120 CORT SCR SELF TAP 6.5X105 CANC SCR, FULLY THDED 6.5X105 CANC SCR, 16MM THD 6.5X105 CANC SCR, 32MM THD 6.5X110 CANC SCR, FULLY THDED 6.5X110 CANC SCR, 16MM THD 6.5X110 CANC SCR, 32MM THD 6.5X115 CANC SCR, 32MM THD 6.5X120 CANC SCR, 32MM THD

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 3, 2014

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022

    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 30, 2019

    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 21, 2013

    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 21, 2013