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10,225 catalysts · 3,350 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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10,225 catalysts · 3,350 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
AI grant. $451,000. PI: Bibhuti Bhusan Mishra
NS grant. $250,328. PI: Vincenzo Alessandro Gennarino
AI grant. $249,000. PI: Pei Su
HD grant. $553,065. PI: Lisa M Bebell
AI grant. $835,269. PI: ULRICH H VON ANDRIAN
AI grant. $427,625. PI: Ronit Fraiman
DK grant. $796,742. PI: Stephen Anthony Zderic
AI grant. $412,749. PI: Christopher D Scharer
AI grant. $3,601,712. PI: Alexander Marson
HD grant. $66,310. PI: Lisa M Bebell
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL
Sponsor: QOL MEDCL. Form: SPRAY, METERED. Route: NASAL
Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL
Sponsor: APOTEX INC. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: CAPSULE. Route: ORAL
Sponsor: USPHARMA. Form: PATCH. Route: TOPICAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Abbreviated
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 — Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. — Status: Ongoing
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable — Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. — Status: Ongoing
AI grant. $384,939. PI: Michael James Holmes
AI grant. $332,414. PI: Michaelle Chojnacki