14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: India
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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 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 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
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
FDA Enforcement
Class II
·Ongoing·Wipro GE Healthcare Private Ltd.·October 29, 2025
Micro Plate Centrifuge
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device
Gel Card Centrifuge iFuge GC12
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device
Hematocrit Centrifuge
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device
Clinical Centrifuge iFuge CS03 NXT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device
Clinical Centrifuge
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device
Cytoslide Centrifuge iFuge CYTO
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Accumax Lab Devices Private Limited·1 device