LIFELINE -UNIPOLAR LEAD #487-05

FDA 510(k)

FDA Class 3 ·Cardiovascular

COAXIAL BALLOON URETHRAL DILATOR

FDA 510(k)

FDA Class 3 ·Unknown

PROLITH MODEL 21S CARDIAC PULSE GEN.

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS UL-804 AND BL-801 UNIPOLAR LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

JUMP START, MODEL 970300

FDA 510(k)

FDA Class 3 ·Cardiovascular

SPINAL SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

PACEMAKER, PERM. & TEMP., ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

VENTRICULAR PACING LEADS MODELS 865/867

FDA 510(k)

FDA Class 3 ·Cardiovascular

Antigen, Cancer 549

FDA classification

FDA Class 3 ·Antigen, Cancer 549

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification

FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA classification

FDA Class 3 ·Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification

FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

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

FDA classification

FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA classification

FDA Class 3 ·Prostrate Cancer Genes Nucleic Acid Amplification Test System

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

FDA classification

FDA Class 3 ·Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA classification

FDA Class 3 ·Antigen(Complexed),Prostate Specific,(Cpsa)

P2psa

FDA classification

FDA Class 3 ·P2psa

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA classification

FDA Class 3 ·Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum