MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAIG OBTURATOR, CATHETER INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE PATIENT CABLE MODEL 5807

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED LABELING TO PERMANENT LEAD INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS

Sleepio®

FDA 510(k)

FDA Class 2 ·Neurology

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Daylight

FDA 510(k)

FDA Class 2 ·Neurology

BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·HIGHSAIL CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM