Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE CARDIAC RESYNCHRONIZATION THERAPY - PACEMAKER (CRT-P)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

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

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSINGS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE Viabahn Endoprosthesis with Heparin Bioactive Surface

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas® HBV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Methafilcon A and Methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER VS100 IOLS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS® SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV