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21,474 catalysts · 4,728 grant · 3,622 8k filing · 3,608 device 510k · 2,957 approval · 2,000 device pma · 2,000 device recall
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21,474 catalysts · 4,728 grant · 3,622 8k filing · 3,608 device 510k · 2,957 approval · 2,000 device pma · 2,000 device recall
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
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System) — Reason: Potential that the measured value may be smaller than the actual area. — Status: Ongoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable — Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Status: Ongoing