10,000 results · 1064ms · 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