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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
DC grant. $473,749. PI: Artur Indzhykulian
AI grant. $1,000,000. PI: Nathan Allan Stasko
NS grant. $499,863. PI: Christopher Dockendorff
AG grant. $499,940. PI: Vladislav Bergo
DE grant. $655,455. PI: Mildred Christine Embree
AA grant. $3,291,402. PI: Anna E. Jaffe
CA grant. $183,835. PI: Montserrat Soler
HD grant. $54,594. PI: krystle perez
ES grant. $127,384. PI: Matthew Allen Schaich
AI grant. $481,214. PI: Yohei Doi
AA grant. $248,999. PI: Severine Patricia Lannoy
Product code: DQD. Advisory committee: Cardiovascular. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: ONB. Advisory committee: General Hospital. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MXD. Advisory committee: Cardiovascular. Type: Special
Product code: LHN. Advisory committee: Radiology. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: IRT. Advisory committee: Physical Medicine. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRL. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LYJ. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B — Reason: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. — Status: Ongoing
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure. — Reason: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Cardiac Workstation 5000; Model Number: 860439; — Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. — Status: Ongoing