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13,309 catalysts · 3,603 8k filing · 2,401 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 931 device pma
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13,309 catalysts · 3,603 8k filing · 2,401 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 931 device pma
VA grant. PI: Jessica M Ross
VA grant. PI: Nichole Goodsmith
VA grant. PI: Nipa P Kamdar
VA grant. PI: Frances Aunon
VA grant. PI: Wei Dong
VA grant. PI: Kristina L Bailey
VA grant. PI: William Dean Lack
AA grant. $40,186. PI: Brooke Ruth Hafer
CA grant. $37,613. PI: Collin James Harlan
AI grant. $11,187. PI: Lisa M Bebell
GM grant. $155,484. PI: JIAN ZHAO
VA grant. PI: Alex Bryant
DK grant. $74,632. PI: Madigan Snyder
VA grant. PI: Arianne K Baldomero
VA grant. PI: JONG H YOON
VA grant. PI: Jonathan D Cherry
MH grant. $43,420. PI: Jana Hicham Badrani
GM grant. $75,052. PI: Omar M. Hedaya
VA grant. PI: MARTIN J GALLAGHER
VA grant. PI: MONIQUE Eun Hee CHO
Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL
Product code: GXP. Advisory committee: Neurology. Type: Special
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Special
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. — Reason: Tyvek bag seal issue which may compromise sterility of the kit. — Status: Ongoing
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing
NS grant. $42,647. PI: Colista Sue West
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: SUSPENSION. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: LTJ. Advisory committee: Immunology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30