BEUDAMED
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    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 Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class II ·Ongoing·Wipro GE Healthcare Private Ltd.·October 2, 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 Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

    FDA Enforcement
    Class II ·Ongoing·Wipro GE Healthcare Private Ltd.·October 29, 2025

    GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class II ·Ongoing·Wipro GE Healthcare Private Ltd.·October 2, 2024

    Sahajanand Medical Technologies Limited

    Manufacturer
    🇮🇳 India·642 Basic UDI-DIs·642 Devices·2 Importers·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    Quality Needles Private Limited

    Manufacturer
    🇮🇳 India·2495 Basic UDI-DIs·2495 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    EUCARE PHARMACEUTICALS PRIVATE LIMITED

    Manufacturer
    🇮🇳 India·12 Basic UDI-DIs·12 Devices·1 Importer·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    Paramount Surgimed Limited

    Manufacturer
    🇮🇳 India·36 Basic UDI-DIs·36 Devices·9 Importers·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    Multimedics LLP

    Manufacturer
    🇮🇳 India·45 Basic UDI-DIs·45 Devices·1 Importer·DNV Product Assurance AS and DNV Product Assurance AS

    Lifelong Meditech Private Limited

    Manufacturer
    🇮🇳 India·15 Basic UDI-DIs·15 Devices·1 Importer·DNV Product Assurance AS and DNV Product Assurance AS

    Appasamy Associates Private Limited

    Manufacturer
    🇮🇳 India·2 Basic UDI-DIs·2 Devices·DNV Product Assurance AS

    Fanem Medical Devices India Private Limited

    Manufacturer
    🇮🇳 India·4 Basic UDI-DIs·4 Devices·DNV Product Assurance AS

    TTK Healthcare Limited (Ortho Division)

    Manufacturer
    🇮🇳 India·48 Basic UDI-DIs·48 Devices·DNV Product Assurance AS

    MHL Healthcare Limited

    Manufacturer
    🇮🇳 India·15 Basic UDI-DIs·15 Devices·DNV Product Assurance AS

    Appasamy Associates Private Limited

    Manufacturer
    🇮🇳 India·3 Basic UDI-DIs·3 Devices·DNV Product Assurance AS