10,000 results · 43ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

FDA Pre-Market Approval
MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RX5000 PROGRAMMER

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL

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

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·Koning Breast CT, KBCT

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARASTAR™ Pulsed Field Ablation

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune Gio

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

hyperbaric oxygen treatment chamber

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Submarine Manufacturing & Products Ltd·1 device

Hyperbaric oxygen treatment chamber

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Submarine Manufacturing & Products Ltd·1 device

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav MiFi Open-Irrigated Ablation Catheter

Oral Fluid Multi-Panel Drug Test Kit (THC/AMP/ OPI/MET/COC /BZO)

Device
EU IVDD · Eu Ivd General ·Hangzhou Immuno Biotech Co., Ltd·On the market