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40 catalysts · 15 device 510k · 13 approval · 5 device pma · 4 device recall · 3 grant
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40 catalysts · 15 device 510k · 13 approval · 5 device pma · 4 device recall · 3 grant
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GENSCO. Form: FILM. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: RISING. Form: CAPSULE. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL
Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: JOURNEY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCS. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: KPO. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: QSK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QZH. Advisory committee: TX. Decision: APPR
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MJO. Advisory committee: OR. Decision: APPR
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. — Reason: Potential for rubber fragment detachment during use. — Status: Ongoing
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. — Reason: Potential for rubber fragment detachment during 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
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