9 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·February 21, 2018
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·February 21, 2018
GE 9100c NXT anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 30 anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·October 11, 2023