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17,939 catalysts · 4,728 grant · 3,606 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,939 catalysts · 4,728 grant · 3,606 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F — Reason: Labeling error, Incorrect expiration date — Status: Ongoing
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION
Product code: KWT. Advisory committee: Orthopedic. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DSA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: PEK. Advisory committee: Orthopedic. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: NWX. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: DSQ. Advisory committee: CV. Decision: APPR
HL grant. $75,520. PI: Hannah Kelsey Fandl
HL grant. $75,052. PI: Brydie Ryan Huckestein
NS grant. $75,052. PI: Adam Farsheed
DE grant. $50,338. PI: Chloe Alexis Munderloh
EY grant. $75,520. PI: Kelli E Cannon
GM grant. $77,752. PI: Stephanie Gu
AI grant. $37,613. PI: Colin Mann
DK grant. $75,520. PI: Sarah Virginia Paramore
GM grant. $75,052. PI: Sara Volz
GM grant. $79,120. PI: John Lee
NS grant. $44,751. PI: Syed Mohammad Adil Wafa
HD grant. $45,200. PI: Ye Eun Esther Yoon
DC grant. $52,538. PI: Candace van der Stelt
NS grant. $42,870. PI: Camilo Londono
NS grant. $49,538. PI: Thomas Payne Newton
DC grant. $44,751. PI: Sarah Ethridge
AG grant. $82,744. PI: Yuan Liu
AI grant. $128,298. PI: Joseph J Eron
AI grant. $1. PI: Joseph J Eron
AI grant. $134,711. PI: Alberto La Rosa
AI grant. $1. PI: Dan H. Barouch
AI grant. $272,708. PI: Joseph J Eron
AI grant. $1. PI: Joseph J Eron
AI grant. $332,850. PI: James Beeson
HD grant. $272,637. PI: Craig D. Newgard
HD grant. $43,138. PI: Logan N Beyer
NS grant. $49,538. PI: Devika Shukla
HD grant. $49,538. PI: Emma Taylor Margolis
EY grant. $49,538. PI: Shannon Hu
NS grant. $42,433. PI: Saovleak Khim
NS grant. $79,552. PI: Adam Lewis Smoulder
AI grant. $44,751. PI: Zachary McDonald Shaver
AR grant. $75,520. PI: Keril Poukalov
CA grant. $33,538. PI: Salma Youssef