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8,953 catalysts · 3,350 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
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8,953 catalysts · 3,350 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
Product code: FWP. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SFP. Advisory committee: Anesthesiology. Type: Traditional
Product code: DTR. Advisory committee: Cardiovascular. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DTZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NUU. Advisory committee: OP. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PJY. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor — Reason: Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring. — Status: Ongoing
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235. — Reason: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. — Status: Ongoing
DK grant. $232,000. PI: ANDREW S GREENBERG
DK grant. $707,062. PI: Xu Xiao
CA grant. $634,644. PI: John A Russell
CA grant. $658,722. PI: Joseph F Costello
DK grant. $681,391. PI: TRACEY MCLAUGHLIN
GM grant. $523,255. PI: Zhao Zhang
GM grant. $616,000. PI: ALICE Y TING
GM grant. $460,625. PI: Robert Charles Brewster
GM grant. $440,000. PI: Shannon Marie Lauberth
NS grant. $616,690. PI: THOMAS L KUKAR
GM grant. $269,500. PI: Barbara Nikolajczyk
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS
Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ORBICULAR. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional