11 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Centricity PACS RA1000
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Enterprise Web
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Radiology RA600
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Cardiology CA1000
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Universal Viewer Zero Footprint Client
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·August 31, 2022
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
FDA Enforcement
Class II
·Ongoing·Defibtech, LLC·December 4, 2024
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·April 9, 2025
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·April 9, 2025