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21,342 catalysts · 4,728 grant · 3,674 8k filing · 3,491 device 510k · 2,901 approval · 2,000 device pma · 2,000 device recall
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21,342 catalysts · 4,728 grant · 3,674 8k filing · 3,491 device 510k · 2,901 approval · 2,000 device pma · 2,000 device recall
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
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing