926 results · 21ms · Sources: EU EUDAMED, US FDA

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

Catheter, Percutaneous, Long Term, Intraspinal

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS NEUROSTIMULATION SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval
FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS NEUROSTIMULATION (IPG) SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM