INSERTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Synq Software Version 1.3

FDA 510(k)

FDA Class 2 ·Radiology

Modus IR

FDA 510(k)

FDA Class 2 ·Radiology

STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TITANIUM CONNECTOR (2 PART)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABARIS

FDA 510(k)

FDA Class 2 ·Radiology

TRUCATH.IP

FDA 510(k)

FDA Class 2 ·Immunology

BrightMatter Plan 1.6.0

FDA 510(k)

FDA Class 2 ·Radiology

PERCUNAV

FDA 510(k)

FDA Class 2 ·Radiology

LGO-Surgical Laser Fibers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Anti-Mutated Citrullinated Vimentin Igg

FDA classification

FDA Class 2 ·Anti-Mutated Citrullinated Vimentin Igg

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Syringe, Balloon Inflation

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation

Syringe, Balloon Inflation, Exempt

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation, Exempt

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535