Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 1000 Defibrillator

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX MRI LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant

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

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL BRAND ABSORBABLE HEMOSTAT

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM ASD Occluder

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier