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9,060 catalysts · 3,350 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
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9,060 catalysts · 3,350 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
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
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem — Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. — Status: Ongoing
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; — 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 FD10F; System Code: 722002; — 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 FD20/10; System Code: 722029; — 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 OR Table; System Code: (1) 722015, (2)722023, (3)722035; — 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 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); — 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 M12; System Code: (1)722078, (2)722223, (3)722233; — 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 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); — 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 FD20/20 OR Table; System Code: 722039; — 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 FD10/10; System Code: (1) 722005, (2)722011, (3)722027; — 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 FD10 OR Table; System Code: (1) 722022, (2)722033; — 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; System Code: 722058; — 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 FD20/20; System Code: 722038; — 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; System Code: (1) 722006, (2)722012, (3)722028; — 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 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); — 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 FD10C; System Code: 722001; — 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 B12; System Code: (1)722067, (2)722225, (3)722235; — 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 FD10; System Code: (1) 722003, (2)722010, (3)722026; — 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
EB grant. $542,947. PI: Brett C Byram
DA grant. $101,214. PI: Jason Richard Paris
AI grant. $19,000. PI: Nicole Franziska Steinmetz