311 results · 20ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS FREE PSA

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

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

FDA Pre-Market Approval
FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT IMX FREE PSA

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval
FDA Class 3 ·MENTOR POLYTEF PASTE /FOR INJECTION

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT ASSAY

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

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA

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 AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval
FDA Class 3 ·FPSA IMMULITE SUBSTRATE REAGENT

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

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Free PSA / Alinity i Free PSA

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 ON THE ACCESS IMMUNOASSAY SYSTEM

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