123 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·July 4, 2012
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
FDA Enforcement
Class II
·Terminated·King Systems Corp.·October 9, 2013
6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HWX·April 13, 2012
3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
LARGE JOYSTICK THREADED PIN, REF 71173339, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
PELVIS PIN, REF 71366302, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HTW·April 13, 2012
SMALL JOYSTICK THREADED PIN, REF 71173396, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HTW·April 13, 2012
3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·April 13, 2012
6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012
JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·April 13, 2012