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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF ASPHERIC UV-ABSORBING RESTOR +2.5 INRAOCULAR LENS & ACRTSOF ASPHERIC UV-ABSORBING RESTOR +3.0 INTRAOCULAR LENS

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ST.JUDE MEDICAL ICDS/CRT-D

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO System Software 9.0

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA PACEMAKER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM FAMILY OF DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700)

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Placental Alpha Microglobulin-1 Immunoassay

FDA classification

FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay