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9,481 catalysts · 3,350 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
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9,481 catalysts · 3,350 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing
TR grant. $3,124,604. PI: Ivan Rusyn
MH grant. $2,039,804. PI: Isabelle Rhyssa Joe Eduria Baconguis
GM grant. $406,250. PI: LIJUN ZHOU
GM grant. $434,000. PI: Owen Samuel Skinner
NS grant. $427,712. PI: WENDY B MACKLIN
NS grant. $420,750. PI: RAVINDRA N SINGH
GM grant. $500,500. PI: J MICHAEL MCINTOSH
MH grant. $75,052. PI: Zhenglong Zhou
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: GLENMARK SPECLT. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: DYE. Advisory committee: CV. Decision: APPR
Product code: SHH. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QPT. Advisory committee: GU. Decision: APPR
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Allura Xper FD20/15 OR Table; System Code: 722059; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 5 M12; System Code: (1)722227, (2)722231; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing