AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS

FDA 510(k)

FDA Class 2 ·Radiology

EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

SYPHER SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EXACTECH CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARENA-C

FDA 510(k)

FDA Class 2 ·Orthopedic

MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PHYCON ALL SILICONE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

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

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

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS 3.5 MM SOFT-WIRE ORION STEERABLE PTCA BALL.