Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG,Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG,Azure S SR MRI IPG,

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT COLLAGEN HEMOSTAT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epsila EV Extravascular Lead

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG, RELIA IPG

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/650/700/800/900/ENPULSE/ADAPTA/VERSA/SENSIA/RELIA IPGS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN & SEVEN PLUS SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T; Iforia 7 VR-T; Ilesto 5 VR-T; Iforia 5 VR-T; Ilesto 7 VR T DX; Iforia 7 VR-T DX; Ilesto 5 VR-T DX; Iforia

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software