4,549 results · 42ms · Sources: EU EUDAMED, US FDA

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit(Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica® IM Prostate-Specific Antigen (PSA) Assay

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·Fluency® Plus Endovascular Stent Graft