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9,311 catalysts · 3,180 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
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9,311 catalysts · 3,180 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
AI grant. $616,042. PI: Chrysothemis Brown
AI grant. $444,125. PI: PEDRO GAZZINELLI GUIMARAES
DC grant. $818,502. PI: Rachel Reetzke
AI grant. $610,971. PI: Emily K. Moser
MH grant. $863,276. PI: Megumi J Okumura
NS grant. $236,250. PI: Ahmet ARAC
AI grant. $762,847. PI: Dane Parker
AI grant. $448,089. PI: John Tanner Wilson
AI grant. $435,379. PI: Janani Ravi
AI grant. $227,115. PI: Cara Theresia Pager
NS grant. $669,891. PI: Kurt William Farrell
AI grant. $648,891. PI: Joseph Richard McMillan
AI grant. $798,107. PI: Amy K Barczak
NS grant. $121,554. PI: Sidar Aydin
AI grant. $444,125. PI: JOHN M HAWDON
AI grant. $455,500. PI: Cristiana Cairo
AI grant. $431,750. PI: George S. Yap
AI grant. $755,801. PI: STEFAN FESKE
AI grant. $466,125. PI: Juan Lafaille
AI grant. $440,908. PI: Paul R Carlier
NS grant. $264,746. PI: Shawn L. Hervey-Jumper
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INTRAVENOUS
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing
Product code: QHE. Advisory committee: Orthopedic. Type: Special
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: PNO. Advisory committee: Cardiovascular. Type: Special
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Special
Supplement type: 30-Day Notice. Product code: QVG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing
AI grant. $439,250. PI: Matthew Daugherty
AI grant. $610,124. PI: Soman N Abraham
HD grant. $35,832. PI: Pond Ezra
DC grant. $779,636. PI: Brian Lin
DK grant. $765,558. PI: Shengmin Sang
AI grant. $437,250. PI: Ryan K Shields