935 results · 19ms · Sources: EU EUDAMED, US FDA

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)
FDA Class 3 ·Cardiovascular

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice HRD CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice HRD CDx

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDx BRCA HRD

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX KIT

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

FDA Pre-Market Approval
FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA SR MRI

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO OCCLUDER

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR-PERL Ridaforolimus Eluting Coronary Stent System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON®

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLES 30 & 31 POSTERIOR CHAMBER IOLS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System