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13,570 catalysts · 3,431 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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13,570 catalysts · 3,431 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 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
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B 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 Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. 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
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 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 Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. 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
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 — Reason: Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation. — Status: Ongoing
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