42 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: China
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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
Bodor P and C series laser cutting machines
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·January 29, 2025
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·February 21, 2018
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 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·February 21, 2018
Dental Zirconia Block
Device
EU MDD
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Eu Md Class 2a
·Shenzhen Yurucheng Dental Materials Co., Ltd.·On the market·2 countries
Dental Zirconia Block
Device
EU MDD
·
Eu Md Class 2a
·Shenzhen Yurucheng Dental Materials Co., Ltd.·On the market·2 countries
Shouren
Device
EU MDR
·
Eu Md Class 1
·Shaoxing Shouren Medical Health & Technology Co., Ltd.·On the market
Pen Needle
Device
EU MDR
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Eu Md Class 2a
·Beijing Fert Technology Co., Ltd.·On the market·1 country
PUSH WHEELCHAIRS
Device
EU MDR
·
Eu Md Class 1
·Anhui JBH Medical Apparatus Co., Ltd·On the market·32 countries
FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER
Device
EU MDR
·
Eu Md Class 1
·Yongkang beiqin industry and trade co.,ltd·On the market·32 countries
Quik-Check U500 Urine Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries
Leukemia DEK-CAN Fusion Gene Real Time RT-PCR Kit
Device
EU IVDD
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Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·On the market
PTA BALLOON DILATATION CATHETERS
Device
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·On the market·1 country
Dental Zirconia Block
Device
EU MDD
·
Eu Md Class 2a
·Shenzhen Yurucheng Dental Materials Co., Ltd.·On the market·2 countries