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9,637 catalysts · 3,189 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 device 510k · 584 earnings
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9,637 catalysts · 3,189 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 device 510k · 584 earnings
Supplement type: Panel Track. Product code: OYB. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DXY. 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: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. — Status: Ongoing
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
IBA Proton Therapy System - PROTEUS 235 — Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used. — Status: Ongoing
AI grant. $803,591. PI: GEORGE M SHAW
AI grant. $411,780. PI: Yifan Wang
AI grant. $422,125. PI: Anthony T Maurelli
AI grant. $491,663. PI: Wenhao Chen
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