45 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: China
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GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
SunLED 1/MB
Device
EU MDR
·
Eu Md Class 1
·Mediland Medical Equipment Enterprise Corporation Company·On the market
NITRILE EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
NITRILE EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
NITRILE EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
Dandl
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
NON-WOVEN GAUZES IN PIECES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
BANDAGES - OTHER (see Y06 for collars, tutors, etc.)
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
VINYL EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
TAPES, MEDICAL/SURGICAL - OTHER
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
TAPES, MEDICAL/SURGICAL - OTHER
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
NITRILE EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
VINYL EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market
SAMPLE COLLECTION NEUTRAL SWABS
Device
EU MDR
·
Eu Md Class 1
·VANDL BIOTECHNOLOGY INC·On the market