10,000 results
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1064ms
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Sources: EU EUDAMED, US FDA
i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
i-STAT G cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG4+ Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G3+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
Sejoy Biomedical Co., Ltd.
Manufacturer
🇨🇳 China·64 Basic UDI-DIs·64 Devices·14 Importers·TÜV Rheinland LGA Products GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Drill Guide, VA
FDA registration
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED·2 products·🇮🇳 India
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4)
FAJA CONTENCION FLEMING 4 BANDAS T/1
Device
EU MDR
·
Eu Md Class 1
·Fleming Comercial, S.A.·On the market
FAJA CONTENCION FLEMING 4 BANDAS T/1
Device
EU MDR
·
Eu Md Class 1
·Fleming Comercial, S.A.·On the market
FAJA CONTENCION FLEMING 3 BANDAS T/1
Device
EU MDR
·
Eu Md Class 1
·Fleming Comercial, S.A.·On the market
FAJA CONTENCION FLEMING 2 BANDAS T/1
Device
EU MDR
·
Eu Md Class 1
·Fleming Comercial, S.A.·On the market
i-STAT hs-TnI cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M-1 PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
AUROPAL SOLDER M-1
FDA 510(k)
FDA Class 2
·Dental
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer
🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH