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8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
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8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Product code: SHC. Advisory committee: SU. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZY. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNF. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: OOB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR
Burlington Medical, Wrap Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Leg Wraps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Vest — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Demi Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit — Reason: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units — Status: Ongoing
Burlington Medical, Kilt Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing
Burlington Medical, Protective Sleeves. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Frontal Aprons — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing
Burlington Medical, Thyroid Shield. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Caps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Kilt — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
HD grant. $743,116. PI: Christopher Bennett Geyer
NS grant. $544,568. PI: BRUCE D TRAPP
AI grant. $427,625. PI: Ryan Zander
NS grant. $620,504. PI: John Nicholas Betley
NS grant. $243,750. PI: Xiaofeng Guo
NS grant. $80,000. PI: Roxana Gabriela Burciu
NS grant. $508,533. PI: JAVIER F MEDINA
NS grant. $644,345. PI: Christopher G. Favilla