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10,186 catalysts · 3,311 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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10,186 catalysts · 3,311 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL
Sponsor: ORBION PHARMS. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: WATSON LABS TEVA. Form: TABLET. Route: ORAL
Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: RADIUS. Form: TABLET, EFFERVESCENT. Route: ORAL
Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: QILU PHARM HAINAN. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION
Sponsor: APIL. Form: TABLET. Route: ORAL
Sponsor: ORGANON LLC. Form: TABLET. Route: ORAL
Sponsor: NANG KUANG PHARM CO. Form: INJECTABLE. Route: INTRAVENOUS
Product code: QVS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Special
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: DRT. Advisory committee: Cardiovascular. Type: Traditional
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QBJ. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: OYB. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
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