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13,623 catalysts · 3,603 8k filing · 2,401 grant · 2,100 approval · 1,445 device 510k · 1,074 device recall · 1,000 device adverse event
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13,623 catalysts · 3,603 8k filing · 2,401 grant · 2,100 approval · 1,445 device 510k · 1,074 device recall · 1,000 device adverse event
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Special
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: PGY. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PYX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QPT. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NKE. Advisory committee: CV. Decision: APPR
Product code: QTL. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MYL. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: SDQ. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 — Reason: There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room. — Status: Ongoing
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520; — Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. — Status: Ongoing
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660; — Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. — Status: Ongoing
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560; — Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. — Status: Ongoing