34 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 LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Huizhou Anboson Technology Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Sterile hypodermic syringe for single use without needle
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market
Sterile hypodermic syringe for single use without needle
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market
Sterile hypodermic syringe for single use without needle
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market
Laparoscopy l set
Device
EU MDD
·
Eu Md Class 1
·Cobes Industries(Hefei) Co.,Ltd·On the market
ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE
Device
EU MDD
·
Eu Md Class 1
·Tianjin Zhengtian Medical Instrument Co., Ltd.·On the market·2 countries
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
Device
EU MDR
·
Eu Md Class 1
·Wuxi Yushou Medical Appliances Co.,Ltd.·On the market·1 country
PTA BALLOON DILATATION CATHETERS
Device
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·On the market·1 country
Tribest
Device
EU MDR
·
Eu Md Class 1
·Tribest Dental Products Co., Ltd.·On the market·32 countries
JADE PTA (JADE 14 OTW)
Device
EU MDD
·
Eu Md Class 2a
·OrbusNeich Medical (Shenzhen) Co.,Ltd·On the market·1 country