Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ABSORBABLE HEMOSTAT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Verds, Sensia IPG ; Advisa DR IPG; Advisa DR & SR MRI IPG; Relia IPG

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT-

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Coronary Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT0P, Syncra CRT-P, Viva CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Reno MRI SureScan IPG

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Coronary Stent System

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSymm, iSpheric IOL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity™, RHA® Redensity™ Mepi, RHA®2, RHA®2 Mepi, RHA®3, RHA®3 Mepi, RHA®4, RHA®4 Mepi

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·R Series MCU 20.01 software release

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

FDA Pre-Market Approval

FDA Class 3 ·Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Fortify Assura , Ellipse

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GEL-ONE(R)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALTRUA 2, ESSONTIO, PROPONENT, ACCOLADE, ADVANTIO, INGENIO, VITALIO, Non-MRI Pacemakers