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18,423 catalysts · 4,728 grant · 3,288 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,423 catalysts · 4,728 grant · 3,288 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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
Millenium MPR; 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
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 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. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Elscint Model 4XX; 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
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated — Reason: Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied — Status: Ongoing
Millenium MG/MC; 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
Product: STA Liatest D-Di; REF: 00515; — Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. — Status: Ongoing