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10,436 catalysts · 3,350 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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10,436 catalysts · 3,350 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: MSN. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: KINDOS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS
Sponsor: APOTEX INC. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL
Sponsor: NOVITIUM PHARMA. Form: SOLUTION. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
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