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21,263 catalysts · 4,728 grant · 3,686 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
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21,263 catalysts · 4,728 grant · 3,686 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). — Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. — Status: Ongoing
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
EB grant. $7,140. PI: Stacy Marla Copp
AG grant. $46,086. PI: Anna Saylor
NR grant. $1,422,387. PI: EILEEN T LAKE
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
AA grant. $78,520. PI: Meredith Rose Bauer
AG grant. $401,404. PI: Rugang Zhang
CA grant. $766,371. PI: Ting-Yuan Cheng
NS grant. $242,250. PI: Ukpong Bassey Eyo
AG grant. $700,795. PI: VISHWA DEEP DIXIT
NS grant. $136,620. PI: Rose Berthe Creed
AG grant. $441,460. PI: Fan Fan
DK grant. $832,783. PI: Todd Christopher Bradley
GM grant. $243,046. PI: Eric James Horstick
AG grant. $49,538. PI: Allegra Kawles
GM grant. $264,270. PI: Ryan L Hanson
CA grant. $267,208. PI: Ren Xu
AI grant. $482,625. PI: Jonah B. Sacha
AG grant. $666,504. PI: Christopher Fry
AI grant. $423,500. PI: Maria Bettini
AG grant. $19,600. PI: TERRY L. SHEPPARD
TW grant. $185,185. PI: JOSEPH W HOGAN
AI grant. $51,600. PI: Barry Ryan Lutz
CA grant. $352,275. PI: Minna Roh
AI grant. $80,224. PI: Anastacia R Parks
HD grant. $151,482. PI: Lila A Sheira
AG grant. $618,410. PI: Danapala M. M. Janaka Senarathna
AR grant. $15,000. PI: Stephanie Kliethermes
NS grant. $511,402. PI: Cenk Ayata
AG grant. $552,154. PI: Jason Wright
NS grant. $247,995. PI: Nicolas Julian Abreu
DK grant. $193,075. PI: Angelina Dixon
AI grant. $739,353. PI: Murali Prakriya
AG grant. $689,148. PI: KENNETH WALSH
AG grant. $127,710. PI: Aleda Leis
AI grant. $51,676. PI: Russell Ryan Kempker
NR grant. $46,559. PI: Katherine Erin Kruger
AG grant. $589,614. PI: Andrew ASCHENBRENNER
HD grant. $44,280. PI: Sinclair William Emans
VA grant. PI: Phoebe Tsao
HL grant. $54,538. PI: Stephanie Danni Song
DK grant. $709,369. PI: Ciro Maurizio Amato
AG grant. $680,818. PI: Andrew Patrick Ambrosy
DC grant. $618,089. PI: Rita R Patel
DK grant. $757,885. PI: Sanjeev Kumar
AI grant. $429,000. PI: Matthew Carl Surdel
NS grant. $575,485. PI: Andrew P Escayg
AG grant. $1,232,416. PI: William Brent Clayton
AG grant. $481,250. PI: Volker Hans Haase