System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASIST DEVICE

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SUSTAIN XL FAMILY OF PACEMAKERS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed