System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·CARDIOVERSION SWITCHBOX II SYSTEM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM215 Growth Factor Enhanced Matrix

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ADAPTER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BioMimics 3D Vascular Stent System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Extensions

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate™ Irrigation Tubing Set

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX SODIUM HYALURONATE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx