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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
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
Supplement type: Normal 180 Day Track No User Fee. Product code: LTI. Advisory committee: GU. Decision: APPR
Product code: LPB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 — Reason: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. — Status: Ongoing