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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·December 26, 2012

    DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012

    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 15, 2013

    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 28, 2017

    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 28, 2017

    DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 28, 2017

    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 28, 2017

    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 28, 2017

    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 14, 2023

    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 14, 2023

    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 14, 2023

    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 14, 2023

    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·June 14, 2023

    DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013

    DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013

    COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·March 19, 2025

    COR Disposable Kit, 8 mm. Cartilage Transplant System.

    FDA Enforcement
    Class II ·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·March 19, 2025

    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 1, 2013

    ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 1, 2013

    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 1, 2013