5,924 results · 150ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICDS

Bone Plugger

FDA registration
Auxein medical Private limited·1 product·🇮🇳 India

Labomed Stella OPH microscope with wall mount

FDA UDI
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED·08908006463268·'- Maxlite coated Motorized 5 Step Zoom, 0.4X...

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon System with Navigation and Touch

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK RX PENTA CORONARY STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE

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

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Alto Abdominal Stent Graft System

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

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

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM

Labomed Stella OPH microscope

FDA UDI
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED·08908006463251·'- Maxlite coated Motorized 5 Step Zoom, 0.4X...

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM