2,280 results · 36ms · Sources: EU EUDAMED, US FDA

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Disposable EEG Cup Electrode

FDA registration
TECHNOMED ASIA, PT.·1 product·🇮🇩 Indonesia

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

P2psa

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex reagent cartridge

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Dimension FPSA Flex reagent cartridge

V-10220128-628

FDA registration
Foundation Wellness International Co., LTD (FWIL)·1 product·🇻🇳 Vietnam

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA ASSAY

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS AFP IMMUNOASSAY SYSTEM

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

DOMAS

FDA registration
PT. Dutamulti Intioptic Pratama·1 product·🇮🇩 Indonesia

Sterilex

FDA registration
SOLOMED S.A. DE C.V.·1 product·🇲🇽 Mexico

DIANCEHT, S.A DE C.V.

FDA registration
DIANCEHT, S.A DE C.V.·1 product·🇲🇽 Mexico

Ponfecare

FDA registration
SOLOMED S.A. DE C.V.·1 product·🇲🇽 Mexico

LOMX SA DE CV

FDA registration
LOMX SA DE CV·1 product·🇲🇽 Mexico

Laboratorios PiSA, S. A. de C.V.

FDA registration
Laboratorios PiSA, S. A. de C.V.·1 product·🇲🇽 Mexico