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9,449 catalysts · 3,147 8k filing · 2,043 grant · 1,000 device adverse event · 973 approval · 698 device 510k · 584 earnings
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9,449 catalysts · 3,147 8k filing · 2,043 grant · 1,000 device adverse event · 973 approval · 698 device 510k · 584 earnings
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: DRT. Advisory committee: Cardiovascular. Type: Special
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: LYK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: NDN. Advisory committee: Orthopedic. Type: Traditional
Product code: OBH. Advisory committee: Cardiovascular. Type: Traditional
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Special (Immediate Track). Product code: EZY. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SGV. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: POH. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NPV. Advisory committee: CV. Decision: APPR
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. — Reason: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. — Status: Ongoing
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL — Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection. — Status: Ongoing
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT — Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection. — Status: Ongoing
AI grant. $921,320. PI: Michaelle Chojnacki
AI grant. $3,178,476. PI: Michael S Glickman
AI grant. $883,295. PI: Matteo Porotto
AI grant. $1,042,346. PI: ANDREW W GRIMSON
NS grant. $47,079. PI: Thu-Lan Lily Nguyen
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GENSCO. Form: FILM. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: RISING. Form: CAPSULE. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL
Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: JOURNEY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCS. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional