Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval

FDA Class 3 ·Thoraflex™ Hybrid

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Selenia Dimensions 3D System.

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

FDA Pre-Market Approval

FDA Class 3 ·EBK RIA ASSAY/ETI-EBK

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse® Lips+

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA ASSAY

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingevity MRI

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE INTRAOCULAR LENSES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) LENSES

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·Esteem Totally Implantable Hearing Device

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·RESONATE, VIGILANT NG4 CRT-Ds, AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 CRT-Ds, ACUITY™ X4 Leads, Slit Suture Sleeve Accesso