51 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
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 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
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 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
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
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 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
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
ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. 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 OS-6 Reverse Cutting Needles, Product Code: 223116. 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
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 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