KODAK T-MAT H FILM SO-118

FDA 510(k)

FDA Class 3 ·Unknown

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS-SWISS DOLORCLAST

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS SWISS DOLORCLAST

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CHECKMATE SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMIC TRANSCEND ARTICULATION SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002

Tissue Graft Of Less Than 6mm

FDA classification

FDA Class 3 ·Tissue Graft Of Less Than 6mm

Tissue Graft Of 6mm And Greater

FDA classification

FDA Class 3 ·Tissue Graft Of 6mm And Greater

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS UNI TOTAL KNEE SYSTEM

Electrical Impedance Spectrometer

FDA Pre-Market Approval

FDA Class 3 ·NEVISENSE

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval

FDA Class 3 ·MELAFIND