15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: India
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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 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
ClearLLab Compensation Kit
Device
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter India Private Limited·On the market·32 countries
ClearLLab LS Lymphoid Screen Reagent
Device
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter India Private Limited·On the market·32 countries
BIO MECAJECT
Device
EU MDR
·
Eu Md Class 2a
·BIO-TECH VISION CARE PVT. LTD.·On the market·1 country
BIO HYDROJECT
Device
EU MDR
·
Eu Md Class 2a
·BIO-TECH VISION CARE PVT. LTD.·On the market·1 country
OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE
Device
EU MDR
·
Eu Md Class 2a
·BIO-TECH VISION CARE PVT. LTD.·On the market·1 country
STICKS/LANCETS/STRIPS FOR OPHTHALMIC USE
Device
EU MDR
·
Eu Md Class 1
·BIO-TECH VISION CARE PVT. LTD.·On the market
STICKS/LANCETS/STRIPS FOR OPHTHALMIC USE
Device
EU MDR
·
Eu Md Class 1
·BIO-TECH VISION CARE PVT. LTD.·On the market
ClearLLab Compensation Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter India Private Limited·1 device
ClearLLab LS Lymphoid Screen Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter India Private Limited·1 device
Intraocular Lens Delivery System
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·BIO-TECH VISION CARE PVT. LTD.·2 devices
IRIS RETRACTOR
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·BIO-TECH VISION CARE PVT. LTD.·1 device
BIO FLUORO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·BIO-TECH VISION CARE PVT. LTD.·1 device
BIO SCHIRMER
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·BIO-TECH VISION CARE PVT. LTD.·1 device