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13,623 catalysts · 3,603 8k filing · 2,401 grant · 2,100 approval · 1,445 device 510k · 1,074 device recall · 1,000 device adverse event
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13,623 catalysts · 3,603 8k filing · 2,401 grant · 2,100 approval · 1,445 device 510k · 1,074 device recall · 1,000 device adverse event
Allura Xper FD20 OR Table; Model Number: 722023; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Allura Xper FD20 Biplane; Model Number: 722013; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 — Reason: Nasal feeding tube packaged without the nasal transfer tube component. — Status: Ongoing
Allura Xper FD10; Model Number: 722026; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Allura Xper FD20; Model Number: 722006; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
AG grant. $716,579. PI: Erik Bradley Bloss
DC grant. $41,394. PI: Bao Le
AG grant. $639,838. PI: MARC D TAMBINI
AG grant. $659,309. PI: Tatiana V Byzova
AG grant. $429,394. PI: Shawn Brady Bender
Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL
Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION
Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: IBSA. Form: FILM. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Product code: OVK. Advisory committee: Immunology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PPW. Advisory committee: Cardiovascular. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: QLR. Advisory committee: Orthopedic. Type: Traditional
Product code: QPC. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NUU. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MWL. Advisory committee: OP. Decision: OK30
Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: Special (Immediate Track). Product code: QBA. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: QIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30