calendar
83 catalysts · 32 approval · 25 grant · 12 device pma · 10 device 510k · 4 device recall
next 91 dayslessmore
MonWedFri
83 catalysts · 32 approval · 25 grant · 12 device pma · 10 device 510k · 4 device recall
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. — Status: Ongoing
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
IBA Proton Therapy System - PROTEUS 235 — Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used. — Status: Ongoing
AI grant. $803,591. PI: GEORGE M SHAW
AI grant. $411,780. PI: Yifan Wang
AI grant. $422,125. PI: Anthony T Maurelli
AI grant. $491,663. PI: Wenhao Chen
AI grant. $616,042. PI: Chrysothemis Brown
AI grant. $444,125. PI: PEDRO GAZZINELLI GUIMARAES
DC grant. $818,502. PI: Rachel Reetzke
AI grant. $610,971. PI: Emily K. Moser
MH grant. $863,276. PI: Megumi J Okumura
NS grant. $236,250. PI: Ahmet ARAC
AI grant. $762,847. PI: Dane Parker
AI grant. $448,089. PI: John Tanner Wilson
AI grant. $435,379. PI: Janani Ravi
AI grant. $227,115. PI: Cara Theresia Pager
NS grant. $669,891. PI: Kurt William Farrell
AI grant. $648,891. PI: Joseph Richard McMillan
AI grant. $798,107. PI: Amy K Barczak
NS grant. $121,554. PI: Sidar Aydin
AI grant. $444,125. PI: JOHN M HAWDON
AI grant. $455,500. PI: Cristiana Cairo
AI grant. $431,750. PI: George S. Yap
AI grant. $755,801. PI: STEFAN FESKE
AI grant. $466,125. PI: Juan Lafaille
AI grant. $440,908. PI: Paul R Carlier
NS grant. $264,746. PI: Shawn L. Hervey-Jumper