Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR COMPONENTS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas TaqMan HBV Test v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cobas HPV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SelectSecure Lead