30 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
FDA Enforcement
Class II
·Terminated·LW Scientific, Inc.·April 3, 2019
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
FDA Enforcement
Class II
·Ongoing·Breas Medical, Inc.·December 6, 2023
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 21, 2018
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 21, 2018