Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASIST DEVICE

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

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

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS HBV TEST

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICAL SNOW ABSORBABLE HEMOSTAT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VENOUS WALLSTENT

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·RESPONSE CV CATHETER SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Digital Breast Tomosynthesis

FDA classification

FDA Class 3 ·Digital Breast Tomosynthesis

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY