Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan and CapSureFix MRI SureScan Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI and Amplia MRI Quad CRT-D SureScan, Compia MRI and Compia MRI Quad CRT-D SureScan and Claria MRI and Claria M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 Plug, Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScan and Sprint Quattro MRI SureScan

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOCYTE PREP SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense Guided Coagulation System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Liver

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·NUXFLEXXA (SODIUM HYALURONATE)

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS