46 results
·
8ms
·
Sources: EU EUDAMED, US FDA
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·January 1, 2014
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 10, 2014
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·July 15, 2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·July 15, 2020
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
FDA Enforcement
Class II
·Terminated·Stryker Corporation·March 14, 2018
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
FDA Enforcement
Class II
·Terminated·ConMed Corporation·December 30, 2020
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
FDA Enforcement
Class II
·Terminated·ConMed Corporation·December 30, 2020
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
FDA Enforcement
Class II
·Terminated·Corflex·January 13, 2016
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 700, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014