calendar
22,638 catalysts · 4,728 grant · 4,332 device 510k · 3,674 8k filing · 3,175 approval · 2,000 device pma · 2,000 device recall
next 91 dayslessmore
MonWedFri
22,638 catalysts · 4,728 grant · 4,332 device 510k · 3,674 8k filing · 3,175 approval · 2,000 device pma · 2,000 device recall
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. — Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. — Status: Ongoing
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. — Reason: When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. — Status: Ongoing
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 — Reason: Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter. — Status: Ongoing
AA grant. $1,742,166. PI: Ziming Xuan
DC grant. $445,861. PI: Brian E. Applegate
AI grant. $448,375. PI: Barbara Anne Bensing
DK grant. $275,275. PI: Muhammad Mujeeb-U-Rahman
HD grant. $43,376. PI: Cyrus Mugo Wachira
EY grant. $699,202. PI: Erik M Ullian
CA grant. $292,963. PI: Xu Han
NR grant. $3,726,027. PI: Lindsay Lawer Shea
MH grant. $980,661. PI: Joseph Novello
HG grant. $396,170. PI: ALEXANDER PERTSEMLIDIS
OD grant. $3,398,996. PI: DOUGLAS W HOUSTON
AI grant. $227,601. PI: CYNTHIA N CORNELISSEN
AA grant. $178,513. PI: Lyonna Francesca Parise
DK grant. $1,276,640. PI: Melanie Maya Kaelberer
DC grant. $567,771. PI: Ryan Michael Corey
HL grant. $1,119,410. PI: Jiantao Ma
LM grant. $828,904. PI: Lu Tang
AI grant. $640,995. PI: ASHWIN BALAGOPAL
MH grant. $608,698. PI: Erin Catherine Meek
CA grant. $352,621
HL grant. $54,538. PI: Xammy Huu Wrynla
HD grant. $313,180. PI: Chinmai Basavaraj
DK grant. $323,850. PI: Saniya Ali
MD grant. $303,389. PI: Courtney Webster
DK grant. $350,000. PI: Douglas Arm
CA grant. $833,467. PI: Kenneth L Kehl
ES grant. $314,745. PI: Donglei Emma Fan
GM grant. $349,910. PI: Cheng Chen
HL grant. $499,932. PI: Prathamesh P Prabhudesai
AI grant. $969,449. PI: Alfredo Andres Celedon
DE grant. $728,647. PI: Kimberley Lynn H Geissler
DK grant. $828,771. PI: KEVIN W WILLIAMS
TR grant. $2,074,744. PI: Julie K Freed
ES grant. $708,061. PI: Lauren Petrick
MD grant. $384,883. PI: Katherine K Kim
MD grant. $306,003. PI: DOUGLAS W BILLINGS
CA grant. $2,052,772. PI: lynn briscoe
MD grant. $313,955. PI: Mika Eddy
CA grant. $195,240. PI: Sangyeon Cho
AA grant. $711,017. PI: JULIANNE Christina Flanagan
NR grant. $273,999. PI: Kamila ANISE Alexander
NS grant. $983,042. PI: STEVEN SCHAEFER
AG grant. $43,404. PI: Yuan Yang
HD grant. $347,016. PI: Vasu V Sethuraman
HG grant. $291,232. PI: Ryan Montes
AI grant. $695,801. PI: Tamar Carter
DC grant. $364,982. PI: William W Graves