calendar
46,427 catalysts · 18,987 approval · 7,299 phase readout · 5,000 device 510k · 4,728 grant · 3,622 8k filing · 2,000 device pma
46,427 catalysts · 18,987 approval · 7,299 phase readout · 5,000 device 510k · 4,728 grant · 3,622 8k filing · 2,000 device pma
MAGNETOM Cima.X Upgrade. Model Number: 11689304. — Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed — Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. — Status: Ongoing
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; — Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues. — Status: Ongoing
VA grant. PI: Alan Benjamin McGuire
VA grant. PI: NEAL S. PEACHEY
VA grant. PI: Brittney C Muir
VA grant. PI: Aasef G Shaikh
VA grant. PI: JOHN A CURCI
VA grant. PI: MARK H. TUSZYNSKI
DA grant. $150,505. PI: Richard Macatee
VA grant. PI: Shirley Ann Cohen-Mekelburg
VA grant. PI: Haijing Wu Hallenbeck
VA grant. PI: Natalie Riblet
VA grant. PI: Juliana V. Baldo
VA grant. PI: Timothy Patrick Hogan
VA grant. PI: Nicole Michelle Weston
VA grant. PI: Takashi Hato
OD grant. $408,750. PI: Emily Kelley Presseller
VA grant. PI: Emily Treichler
TW grant. $164,984. PI: Theresa Stichick Betancourt
VA grant. PI: Kevin Edward Houston
VA grant. PI: Marianna Gasperi
VA grant. PI: ABIDEMI BOLU AJIBOYE
VA grant. PI: David Benner Lombard
VA grant. PI: Christina Lebonville
VA grant. PI: Harikrishna Nakshatri
VA grant. PI: Nathan Adam Boucher
VA grant. PI: Adam Patrick McGuire
VA grant. PI: Monica A Perez
VA grant. PI: Charlie M Wray
VA grant. PI: Hannah Grigorian
VA grant. PI: Sarah Shue
VA grant. PI: Marianne E Casilio
VA grant. PI: Jonathan E Elliott
VA grant. PI: Ziyad Al-Aly
EY grant. $199,749. PI: Christopher Dale Conrady
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS
Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: TEVA PHARMS. Form: SOLUTION. Route: INHALATION
Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION