85 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·December 25, 2013
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·February 7, 2024
GE Healthcare Millennium MC
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·June 27, 2012
Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·April 17, 2013
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Heathcare Giraffe OmniBed; neo natal incubator
FDA Enforcement
Class I
·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
FDA Enforcement
Class I
·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024
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 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 650 A2, Model/REF Number 1012-9650-002. 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 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 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 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025