Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHARGER PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PREDATOR PTCA DILATATION CATHETER

REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

FDA 510(k)

FDA Class 2 ·Orthopedic

High Pressure Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Forehead Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Microwave Ablation Generator (KY-2000A, KY-2100A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNILUX REVIVE AND BLUE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Numen™ Coil Embolization System; NumenFR™ Detachment System

FDA 510(k)

FDA Class 2 ·Neurology

OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·Physical Medicine

ECG Cable/Leadwires

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRACELL ABSORBENT STICK

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Digital Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bladder Scanner

FDA 510(k)

FDA Class 2 ·Radiology

Powered wheelchair (mobility robot) (M4, M4U)

FDA 510(k)

FDA Class 2 ·Physical Medicine

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology