OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER

LASER SHIELDING TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER WITH 3.5 MM BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS

IFA SENSIBAC VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

IFA SENSIBAC TOBRAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

THROMBOSTIN IFA*

FDA 510(k)

FDA Class 2 ·Hematology

PACS CORE/ENCORE

FDA 510(k)

FDA Class 2 ·Radiology

IFA SENSIBAC GENTAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

BRUCELLA IFA*

FDA 510(k)

FDA Class 2 ·Microbiology