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8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A — Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. — Status: Ongoing
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) — Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. — Status: Ongoing
DC grant. $490,487. PI: David W Raible
AI grant. $441,204. PI: Derek J Bays
AI grant. $452,375. PI: Adam Mor
AI grant. $508,750. PI: Yongqiang Feng
AI grant. $429,499. PI: WERNER A BRAUN
AI grant. $404,570. PI: STEPHEN J MCSORLEY
AI grant. $744,328. PI: Katherine S Ralston
AI grant. $670,529. PI: Michael Joseph Rybak
AI grant. $681,110. PI: Daniel Swale
AI grant. $825,054. PI: Jennifer Melinda Bomberger
AI grant. $246,881. PI: Stefan Lyne Oliver
GM grant. $440,000. PI: Joshua A Riback
AI grant. $416,279. PI: YOSUKE KUMAMOTO
AI grant. $880,417. PI: Yongqiang Feng
AI grant. $411,704. PI: Zach N. Adelman
AI grant. $224,368. PI: Chong Wang
AI grant. $447,960. PI: Andrew Olive
NS grant. $216,025. PI: Jessica C Jimenez
AI grant. $511,531. PI: Kimmo Ilmari Rantalainen
AI grant. $418,985. PI: Rita V M Rio
AI grant. $453,063. PI: Matthew Brewer
AI grant. $192,500. PI: Jianguo Liu
AI grant. $234,715. PI: Alexei V Tumanov
GM grant. $457,875. PI: OSCAR VARGAS-RODRIGUEZ
HL grant. $437,119. PI: HENRY N GINSBERG
AI grant. $426,250. PI: Anup Ramachandran
GM grant. $429,000. PI: Ariel Bazzini
AI grant. $422,125. PI: ALEXANDER MICHAEL COLE
AI grant. $186,953. PI: Sarah E Clark
AI grant. $242,250. PI: Micah T. McClain
DK grant. $50,114. PI: Hannah A Anderson
Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL
AG grant. $408,504. PI: BERNARD CHOI
NS grant. $249,000. PI: Xin Chen
AG grant. $738,105. PI: MARK J SIEDNER
AG grant. $624,837. PI: Randy R Brutkiewicz
DK grant. $683,660. PI: John Cijiang He
AG grant. $676,587. PI: Robert Tyler Braun
AG grant. $427,625. PI: Gretchen A Meyer
GM grant. $457,875. PI: Abhijit Deb Roy
DA grant. $193,752. PI: Lynsie Ranker
DA grant. $647,142. PI: Shanna Babalonis
DK grant. $763,647. PI: Chengwen Li