5,924 results · 151ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR® 1-piece IOL, AAB00, TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00, TECNIS® 1-Piece OptiBlue

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC

Advena Limited

Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval
FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (RX)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·KONTUR 55 EW

TruFire™ Suture Passer with Non-Ratcheting Handle

FDA registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD·1 product·🇮🇱 Israel

CrossRoads™ Screw

FDA UDI
CROSSROADS EXTREMITY SYSTEMS·00815432027514·The CrossRoads™ Screw System is indicated for f...