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25,951 catalysts · 16,950 approval · 3,627 device 510k · 2,351 grant · 1,190 device recall · 1,071 device pma · 762 recall
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25,951 catalysts · 16,950 approval · 3,627 device 510k · 2,351 grant · 1,190 device recall · 1,071 device pma · 762 recall
CA grant. $498,565. PI: Surbhi Grover
CA grant. $1,033,055. PI: Bianxiao Cui
ES grant. $124,728. PI: Jagadeesh Puvvula
AI grant. $2,536,503. PI: Laura B Dickson
HG grant. $3,349,527. PI: Anne O'Donnell-Luria
DE grant. $716,123. PI: CHRISTINE H CHUNG
CA grant. $1,549,462. PI: Timothy William Mullett
AG grant. $77,752. PI: Julianne Clina
DC grant. $75,052. PI: Melissa C Franch
GM grant. $2,313,209. PI: Sathish K Ramakrishnan
DK grant. $759,135. PI: Lily Dara
HL grant. $37,289. PI: Elizabeth Mariya Engle
GM grant. $361,283. PI: Roy Rabinu Lederman
ES grant. $631,279. PI: Ellen Joan Bluth
CA grant. $197,518. PI: Theodore Willis Laetsch
NS grant. $302,782. PI: Sherif M Elbasiouny
CA grant. $703,321. PI: Erin Elizabeth Hahn
HD grant. $2,416,587. PI: Sharon Dekel
DK grant. $315,747. PI: Yan sHI Zhao
CA grant. $406,500. PI: Kenneth Schultz
DK grant. $178,026. PI: Justin Xavier Boeckman
HL grant. $1,266,937. PI: Matthew Dominic Bacchetta
NR grant. $3,399,035. PI: LORETTA DIPIETRO
GM grant. $543,750. PI: Christopher L Colbert
Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LOL. Advisory committee: Microbiology. Type: Traditional
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KPO. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: ONN. Advisory committee: Neurology. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DSB. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Product code: MCN. Advisory committee: OB. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). — Status: Ongoing