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10,418 catalysts · 3,332 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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10,418 catalysts · 3,332 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation — Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. — Status: Ongoing
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation — Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. — Status: Ongoing
NR grant. $2,009,207. PI: Karen Blanchette Lasater
AI grant. $466,125. PI: Susan Ruth Schwab
GM grant. $280,905. PI: Sandipan Brahma
Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: CIPLA LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: PLATINUM. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL
Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: IMMUNEX. Form: SYRINGE
Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL
Product code: GQG. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: SCL. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NIU. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30