WAKO AUTOKIT C3

FDA 510(k)

FDA Class 2 ·Immunology

N-ASSAY TIA MULTI V-NL

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY C3

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA 2

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CORONARY CUTTING BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS

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 ·MAVERICK FAMILY PTCA BALLOON CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Sentimag System, Sentimark Magnetic Marker Systerm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER OTW BALLOON DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PERCUTANEOUS CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS