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80 catalysts · 53 grant · 12 device 510k · 8 device pma · 6 approval · 1 device recall
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80 catalysts · 53 grant · 12 device 510k · 8 device pma · 6 approval · 1 device recall
Sponsor: ZYDUS PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: SQUARE PHARMS PLC. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: INGENUS PHARMS LLC. Form: CAPSULE. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Abbreviated
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: SBG. Advisory committee: Neurology. Type: Traditional
Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PRL. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MNQ. Advisory committee: AN. Decision: APPR
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system — Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board. — Status: Ongoing
AI grant. $49,538. PI: Elisabeth Nelson
OD grant. $1,697,492. PI: Amy Louise Cochran
OD grant. $3,996,872. PI: M Daniele Fallin
OD grant. $4,249,998. PI: Margaret Gillis
OD grant. $4,853,391. PI: Ananth V Annapragada
DA grant. $10,000
HD grant. $24,882. PI: PAULA CASTAÑO
AI grant. $1,000,000. PI: MATTHEW DAVIES
DA grant. $1,537,332. PI: ANDY CROUSE
DA grant. $10,550
DA grant. $54,000
DA grant. $9,000
CA grant. $354,878
OD grant. $4,283,587. PI: Laura G Klinger
OD grant. $5,097,004. PI: RAINU KAUSHAL
AG grant. $75,052. PI: Kristi Ann Dietert
DA grant. $16,000
HL grant. $1,236,673. PI: JEAN WACTAWSKI-WENDE
HL grant. $1,121,018. PI: MARCIA STEFANICK
HL grant. $47,440. PI: MARA VITOLINS
AI grant. $499,825. PI: SCOTT SCARNEO
DA grant. $348,217
HL grant. $1,529,606