2,599 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Prostrate Cancer Genes Nucleic Acid Amplification Test System
FDA Pre-Market Approval
FDA Class 3
·PROGENSA PCA3 ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·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 FPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA 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 AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CONTACK RENEWAL IS1/DR1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(TM)
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(TM)
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(TM)
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(R) OSSMOTIC CERVICAL DILATOR
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(R) OSSMOTIC CERVICAL DILATOR
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL OSMOTIC CERVICAL DILATOR
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL OSMOTIC CERVICAL DILATOR
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(R) OSMOSTIC CERVICAL DILATOR
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
FDA Pre-Market Approval
FDA Class 3
·LAMICEL(TM)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace/and Sentimag Magnetic Localization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Localization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System