1,141 results · 20ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA/VERSA/SENSIA IPG

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FEMCARE FILSHIE CLIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VOYAGER RX CORONARY DILATATION CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SENSE BIPOLAR LEAD

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Aid, Surgical, Viscoelastic

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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses