Quantum Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

URODYNAMIC ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation 12 Elite

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL RIGID GAS PERMEABLE CONTACT LENS MATERIAL

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·VISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES

DERMATRON SKIN RESISTANCE METER

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS

Sunrise

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sunrise Sleep Disorder Diagnostic Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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