5,885 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024
DEVICES FOR BODY PROTECTION - OTHER
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS)
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
DEVICES FOR BODY PROTECTION - OTHER
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
ARM AND ELBOW PROTECTIONS
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
DEVICES FOR BODY PROTECTION - OTHER
Device
EU MDR
·
Eu Md Class 1
·SHANDONG ESP HEALTHCARE CO., LTD.·On the market·32 countries
Suzhou Hualun Medical Appliance Co.,Ltd.
Manufacturer
🇨🇳 China·1 Importer
ASTAR ORTHODONTICS INC.
Manufacturer
🇨🇳 China·57 Basic UDI-DIs·5140 Devices·1 Importer
LATEX EXAMINATION / TREATMENT GLOVES
Device
EU MDR
·
Eu Md Class 1
·SUZHOU TEKTOP IMP & EXP CO.,LTD·On the market·32 countries
PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER
Device
EU MDR
·
Eu Md Class 1
·SUZHOU TEKTOP IMP & EXP CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·SUZHOU TEKTOP IMP & EXP CO.,LTD·On the market·32 countries
NASOPHARYNGEAL DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Hangzhou Weize Imp & Exp Co., Ltd.·On the market·32 countries
NASOPHARYNGEAL DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Hangzhou Weize Imp & Exp Co., Ltd.·On the market·32 countries
STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM
Device
EU MDR
·
Eu Md Class 1
·Anqing MedColor Imp. & Exp. Co.,Ltd·On the market·32 countries
STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM
Device
EU MDR
·
Eu Md Class 1
·Anqing MedColor Imp. & Exp. Co.,Ltd·On the market·32 countries
STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM
Device
EU MDR
·
Eu Md Class 1
·Anqing MedColor Imp. & Exp. Co.,Ltd·On the market·32 countries
ODONTOLOGY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Xiamen Yizhou Imp. & Exp. Co., Ltd.·On the market·32 countries
NI01
Device
EU MDR
·
Eu Md Class 1
·NINGBO FUWELL IMP. & EXP. CO.,LTD.·On the market·32 countries
FUNCTIONAL BANDAGES WITH ANELASTIC TAPES
Device
EU MDR
·
Eu Md Class 1
·Hangzhou Weize Imp & Exp Co., Ltd.·On the market·32 countries