BEUDAMED
    116 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·April 3, 2019

    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

    FDA Enforcement
    Class III ·Terminated·Laurimed LLC·May 7, 2014

    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

    FDA Enforcement
    Class III ·Terminated·Covidien LLC·May 22, 2013

    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

    FDA Enforcement
    Class III ·Terminated·Covidien LLC·May 22, 2013

    Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·June 26, 2019

    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·May 1, 2019

    20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·March 30, 2022

    20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·March 30, 2022

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

    FDA Enforcement
    Class III ·Ongoing·Straumann USA LLC·February 18, 2026