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9,961 catalysts · 3,086 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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9,961 catalysts · 3,086 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Supplement type: Special (Immediate Track). Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MCX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SDL. Advisory committee: AN. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PLJ. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
PIE PAK Models: P2HC-A, P2HC-S, P2HC — Reason: Lack of 510K clearance — Status: Ongoing
PIE Trolley System Model: 2005 — Reason: Lack of 510K clearance — Status: Ongoing
GM grant. $196,875. PI: Stephania A Cormier
Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL
Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS. Form: TABLET. Route: ORAL
Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS
Sponsor: SHANDONG. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL
Product code: ODP. Advisory committee: Orthopedic. Type: Special
Product code: PGM. Advisory committee: Orthopedic. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LBI. Advisory committee: General Hospital. Type: Traditional
Product code: OUO. Advisory committee: Radiology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: QHW. Advisory committee: Cardiovascular. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: SGY. Advisory committee: Gastroenterology, Urology. Type: Direct
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Special
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional