675 results · 26ms · Sources: EU EUDAMED, US FDA

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

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

P2psa

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Acess AFP 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

P2psa

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech p2PSA 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

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS

FDA 510(k)
FDA Class 3 ·Unknown

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORY GEL SILICONE GEL- FILLED BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORY GEL SILICONE GEL-FILLED BREAST IMPLANTS

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN GEL

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One