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7,952 catalysts · 3,312 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
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7,952 catalysts · 3,312 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing
TR grant. $3,124,604. PI: Ivan Rusyn
MH grant. $2,039,804. PI: Isabelle Rhyssa Joe Eduria Baconguis
GM grant. $406,250. PI: LIJUN ZHOU
GM grant. $434,000. PI: Owen Samuel Skinner
NS grant. $427,712. PI: WENDY B MACKLIN
NS grant. $420,750. PI: RAVINDRA N SINGH
GM grant. $500,500. PI: J MICHAEL MCINTOSH
MH grant. $75,052. PI: Zhenglong Zhou
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: GLENMARK SPECLT. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional