Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED REBEL PTCA CATHETER

Interlude Rolled Tampons in Plastic Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Interlude 100% Cotton Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

YO Home Sperm Test

FDA 510(k)

FDA Class 2 ·Hematology

Interlude and private label Unscented 3-piece compact applicator tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ADANTE PTCA CATHETER

MD-2300S Ultrasonic A/B Scanner for Ophthalmology

FDA 510(k)

FDA Class 2 ·Radiology

CODMAN-MEDOS VALVE SHUNT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

LITEDUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MD-6000P Bladder Scanner

FDA 510(k)

FDA Class 2 ·Radiology

TI-FRAME

FDA 510(k)

FDA Class 2 ·Orthopedic

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 ·SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER

IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS

FDA 510(k)

FDA Class 2 ·General Hospital

Fit & Brilliant Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

GT990402 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital